A collection of customer success stories
laboratory informatics Business solutions
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[ TABLE OF CONTENTS ]
emPoW er cHromAtoGrAPHY DAtA softWArecompliant-ready software for advanced data acquisition, processing, reporting, and distribution. Provides control of Waters AcQuitY uPlc,® uPc,2® HPlc, and lc/ms systems, as well as non-Waters HPlc, Gc, ce, and PDA systems.
A cro increases competitive Advantage by implementing empower chromatography Data software ..................................7
Becoming Paperless with an integrated laboratory informatics landscape ............................................................................9
improving laboratory efficiency and reducing compliance efforts With a networked chromatography Data system ........ 13
improving Quality control and stability testing efficiency with standardized chromatography operations ...................... 15
supporting innovation by implementing a lean Paperless lab ..............................................................................................17
increasing lab efficiency by chromatography Data system Harmonization ..........................................................................21
manufacturer reduces Vitamin Qc Analysis times by up to 90% ........................................................................................ 23
multi-Vendor instrument control minimizes training and Validation efforts with empower software ................................. 25
eliminating chromatography Data transfer to spreadsheets: reducing errors and improving Productivity with custom calculations using empower software ................................................................. 27
streamlining method Validation in Pharmaceutical Product Development with empower software method Validation manager ............................................................................................................ 29
[ TABLE OF CONTENTS ]
customer success is tHe true meAsure of ProDuct PerformAnce
Waters Laboratory Informatics Software comprises a powerful suite of solutions for instrument control, scientific data management, scientific search, network integration, and compliance management to streamline analytical laboratory operations.
our informatics solutions have helped leading pharmaceutical, environmental, food and beverage, and chemical materials organizations reduce costs, accelerate decision making, improve laboratory effectiveness, and get products to market faster.
[ TABLE OF CONTENTS ][ TABLE OF CONTENTS ]
nuGenesis PlAtformA comprehensive compliance-ready data management and workflow solution that uniquely combines data repository, electronic laboratory notebook, sample management, laboratories inventories, and e-record lifecycle management.
improving Data Accessibility and intellectual Property management with nuGenesis sDms .............................................. 33
employing a Bioanalytical Data management system to increase Workflow efficiency with nuGenesis sDms .................. 35
increasing efficiency in manufacturing Quality control with nuGenesis sDms ................................................................... 39
improving Data management and Accessibility Across multiple Geographies with nuGenesis sDms ..................................41
informatics technology Assists in 21 cfr 11 compliance with nuGenesis sDms ............................................................... 43
optimizing efficiency with electronic regulatory submissions with nuGenesis sDms ........................................................ 45
optimizing image Data Processing and storage for Drug Development with nuGenesis sDms ........................................... 47
regional Healthcare laboratory Automates QA/Qc Process Workflow with nuGenesis eln ............................................... 49
Automation of Doping control Applications with nuGenesis sDms and targetlynx ............................................................51
mAsslYnX softWAreAcquires, analyzes, and distributes Waters mass spectrometry information for comprehensive instrument control and data processing. Application managers automate manual data processing to optimize workflow.
compound Profiling: increasing the throughput of Physicochemical Profiling with Profilelynx Application manager for masslynx software ............................................................................................. 55
High-throughput food safety lab Automates QA Data interpretation and recordkeeping with nuGenesis sDms and masslynx software ............................................................................................. 57
AnAlYticAl WorKfloW mAnAGerProvides a single point of access for the complete handling of all an alytical laboratory tasks.
Analysis order turnaround times reduced by 25% with Analytical Workflow manager .....................................................61
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BACKGROUND
A&m stabtest is an independent private contract research organization (cro) that provides
analytical research and development services for the pharmaceutical industry in support of drug
development programs. the German-based company has headquarters in Bergheim/cologne and
a branch in mainz. the company works for nearly all major pharmaceutical organizations with
clients located primarily in Germany, Austria, switzerland, france, and the Benelux countries.
the company also supports small biotech startup companies with their services.
A&m stabtest specializes in analysis and stability testing of finished pharmaceutical
products and active pharmaceutical ingredients (APis) according to icH requirements;
hence, the test results and documentation need to demonstrate expected quality. t he
company also provides development and product release testing; bioanalytical services;
and unknowns identification. the tested samples range from small molecule drugs
to biopharmaceutical therapies including proteins, peptides and antibodies. All activities
and analyses adhere to GmP/GlP regulations and to demonstrate compliance, the company
is routinely audited by customers and regulatory agencies. A&m stabtest operates in a
cost and time sensitive industry, consequently they continuously invest into efficiency
increasing strategies like employee training and adopting the latest technologies.
CHALLENGE
the laboratories at both sites employ more than one hundred users and operate approximately
50 HPlc instruments manufactured by shimadzu. Additional chromatographic equipment
includes six gas chromatograph instruments from Agilent and two capillary electrophoresis
instruments from Beckman and Agilent.
the HPlc instruments had been running under
the shimadzu class-VP software, which was
used as a hybrid system. only data recording
was performed with the system. chromatograms
were printed on paper and integrated
manually. in order to perform calculations,
data were transferred manually into validated
excel sheets. the different manual activities
required extensive double checks for errors
and corrections when necessary.
Business Benefits
As a result of the Empower
Chromatography Software
implementation, A&M
Stabtest’s scientific operations
have realized a variety of high-
value benefits including:
■■ Efficiency gains, such as a
time savings of 20% for the
result evaluation of a project.
■■ Enhanced response times
during regulatory and
customer audits given the
ease and speed for which
information can be accessed.
■■ Reducing the waste and
variability associated
with the chromatographic
workflow.
■■ Improved laboratory
productivity.
■■ Lower project costs.
■■ Increased competitiveness.
A CRO Increases Competitive Advantage by Implementing Empower Chromatography Data SoftwareClient: A&m stabtest Technology: empower™ chromatography Data software (cDs)
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
8
Waters is a registered tradermark of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2012 Waters corporation. Produced in the u.s.A.July 2012 720004413en iH-PDf
System deployment
today empower is implemented in a citrix environment with
a server at each of the two sites to provide greater system
performance – analysts can access either empower server as
needed to share information. Advantages of operating under a
citrix environment include easy deployment of empower clients
on Pc hardware of differing specifications and streamlined
software validation, since only the empower and citrix servers
require validation.
empower software controls all chromatographic instruments
at both sites including data collection, chromatographic peak
integration, calculations and evaluations, and results review
and approval.
A&m stabtest opted for the integrated system suitability testing
option that allows for direct integration of their results into
reports – manual interaction is no longer required for these steps.
raw data, reports, and audit trails can easily be accessed within
empower, which is very convenient during routine audits.
Waters assisted A&m stabtest with the system Validation by
performing the installation and operation Qualification (iQ/oQ).
Performance Qualification was done by A&m stabtest’s staff.
concurrent with the validation efforts, all end users and power
users were trained by Waters in a test environment to ensure that
they could take full advantage of the empower production system.
With the validated production system in place and system training
for staff completed, A&m stabtest was able to switch from their
legacy system to the new cDs literally overnight.
Due to the competitiveness of the industry, A&m stabtest sought
to minimize waste and variability in the laboratory operations
by reducing time-consuming and error prone manual steps in the
chromatographic testing process.
THE SOLUTION
Platform selection
the decision was made to introduce a modern, state-of-the-art
chromatographic Data system (cDs). the user’s requirements
specification (urs) document developed by the company identified
required functionality, such as Part 11 technical controls, automated
calculations, data management, and multi-vendor instrument
support. As a result of the urs, two cDs solutions were considered,
Waters® empower software and Dionex/thermo chromeleon. the
company chose empower because it satisfied their functionality
requirements and provided an intuitive/professional user interface,
as well as a broad range of multi-vendor instrument drivers
(including those for shimadzu). interfaces were built through
partnerships with the instrument manufacturers to ensure reliability
and future upgrade paths. empower’s market leading position,
reputation for compliance-ready features, and continuous product
improvement solidified the decision.
Regulatory compliance
Because A&m stabtest must comply with regulatory safeguards
and demonstrate this to both customers and government agencies,
empower software functionalities that help facilitate regulatory
compliance are of tremendous value to the company. the data
traceability provided by empower’s audit trails allows staff
to easily locate information during routine audits. Because
speed of retrieval is so critical, the ability to separate audit trail
information by project, method, etc., was considered a key feature.
BACKGROUND
the pharmaceutical division of a global healthcare organization has a comprehensive distribution network
along with major production facilities in europe, north America, latin America, and Asia-Pacific.
the Qc laboratories at one of the company’s large Active Pharmaceutical ingredients (APi) production
sites in europe utilize more than 100 chromatographic instruments manufactured by multiple vendors.
most of the chromatographic operation was controlled by empower chromatography Data software (cDs),
but a second cDs solution was used for some of the instruments. their sample workflow was managed
by Waters® legacy Q-Dis/Qm,™ a classical laboratory information management system (lims), and the
weighing process was supported by Balance View, a third independent system.
CHALLENGE
Although the existing system architecture managed daily chromatographic activities adequately,
integration of these platforms was lacking. As a result, laboratory operations were still dominated by
paper processes. utilizing paper for information exchange was identified as a significant source of waste
and variability, e.g., handling paper documentation was very time-consuming and the related manual
steps were prone to errors. Additionally, archiving the analytical raw data on paper added significant
cost overhead to their laboratory services. for example, a chromatographic sequence that consisted
of 20 samples would equate to the storage of a 50 to 60 page report.
Becoming Paperless with an Integrated Laboratory Informatics LandscapeClient: Pharmaceutical Division of a Global Healthcare organization Technology: empower™ chromatography Data software and nuGenesis® sDms software
Costs for the entire
solution were
recouped in less
than 12 months and
analysis processes
are more than 50%
faster than before.
9
since their laboratory operations adhere to GxP regulations,
customer and regulatory agency audits are a routine part
of business. However, retrieving results and data stored
on paper was a very laborious process. for example, the
Pharmaceutical inspection convention and Pharmaceutical
inspection co-operation scheme (Pic/s) or fDA regulatory
audits, required significant preparation time for structuring paper
data, photocopying the relevant documents and cross-checking.
Additionally, customers throughout the company’s distribution
channels would occasionally request information during root
cause investigations, which would necessitate expending
significant effort to locate and retrieve paper records.
to establish a more automated data flow along with enhanced
data management integrity, the client sought to achieve a fully
integrated laboratory informatics landscape.
T HE SOLUT ION Standardizing on a single CDS
the first step towards comprehensive integration was to standardize
on a cDs - empower software was chosen for this purpose.
the advantages of empower identified by the client include:
■■ continuous product improvements
■■ Ability to run under technologies like citrix
■■ comprehensive Application Programming interface (APi)
for information exchange between external systems
■■ full scalability so it can be extended as needed.
Previous experience with empower software in the client’s
corporate headquarters laboratories further solidified its
selection as the single cDs solution. empower now controls
all chromatographic instruments (over 100) and supports
80 to 90 users at the production site.
A single data repository
Although empower provides comprehensive management of
chromatographic data, the client desired an additional solution
capable of managing information from a wide variety of analytical
techniques. Waters nuGenesis scientific Data management system
(sDms) was introduced into the laboratory to meet these needs.
nuGenesis sDms was implemented to capture all printed reports
for both chromatographic and non-chromatographic results so
that all reports would reside in a single compliance-ready and
searchable data repository. the benefits of a single repository for
reports include a common place for review and approval; easier
retrieval of during an audit; and the ability to summarize and send
reports to other systems such as lims by making using of the APi.
A paperless information workflow
After the adoption of a single cDs for chromatography workflows
and an sDms for all testing reports, it was possible to integrate
the laboratory information workflow together electronically. Work
lists are created within the lims and transferred into an internally
developed database. the weighing system transfers the weights
from the balances into the same database where the weights are
included into the work lists. the relevant data is consolidated
into the work lists and then transferred into the sample sets of
empower software. After performing the tests and calculations
within empower, the reports are generated by empower and
printed into nuGenesis sDms where they can easily be accessed.
the electronic signature workflow includes two checks by different
individuals and is fully supported by nuGenesis sDms. the results
are displayed again before eventually being transferred to the
lims. this entire process, which includes an audit trail, is done
without paper or manual steps, thereby reducing time and errors.
Hence, nuGenesis sDms works as a central data repository where
all chromatographic and related data are securely stored and
can easily be retrieved and accessed. result reports captured
by nuGenesis sDms also appear exactly as they had in paper,
facilitating a high level of acceptance.
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Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
Electronic data retrieval
When customers request information about certain batches they
can now retrieve it themselves within the system based on the
iD number. Granting customers access to data within nuGenesis
sDms can be done confidently – access levels allow them to see
only what they have permission to use. An additional benefit of
electronic searching within the sDms data repository is that the
time required to prepare documentation for audits is almost zero.
Data can be retrieved on short notice independently of record age.
Data can be accessed by relevant search terms (i.e. metadata),
and printed out for the auditor. in total, this takes only ten minutes
(instead of days), which demonstrates to auditors that data
management is effective and compliant.
BUSINESS BENEFIT S
Adoption of empower and nuGenesis sDms as the standard cDs
and sDms solutions (and integration with the lims and sample
weighing system) have allowed the company to transition to
a greater than 90% paperless process in the chromatographic
portion of laboratory operations for APi batch release. this has
led to a number of significant business benefits, including:
■■ increased compliance
■■ reduced errors
■■ increased data security
■■ improved data sharing
■■ streamlined workflow
■■ increased efficiency
■■ significant cost savings (time, storage space, paper)
measurements performed after project completion have
demonstrated that costs for the entire solution were recouped in
less than 12 months and analysis processes are more than 50%
faster than before. the new paperless lab is an important step
towards meeting the company’s first time-right culture.
Waters and nuGenesis are registered trademarks of Waters corporation. empower, Q-Dis/Qm, and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2012 Waters corporation. Produced in the u.s.A.June 2012 720004399en lB-PDf
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BACKGROUND
erregierre is a leading international manufacturer of active ingredients for the pharmaceutical
and generics industries. the company has two cGmP manufacturing sites in italy and
includes a research and Development organization that enables erregierre to provide
fast-track process development and a high level of service in custom synthesis. t he
products include cardiovascular, central nervous system disease, antifungal, anti-
inflammatory, gastrointestinal, anti-allergic, and expectorant areas. the broad area
of products demand about thirty different synthesis reaction categories, which require
high flexibility in the production process, as well as in the accompanying quality control
testing and review. erregierre serves international markets requiring compliance with
fDA and emeA regulations; hence, the business and laboratories must strictly adhere
to GxP regulations.
CHALLENGE
the main site in san Paolo d’Argon includes a Quality control and an Analytical Development
laboratory with 20 HPlc and uPlc® instruments and nine users. the site in sovere has a
Quality control lab where three people work with five HPlc instruments. All of the liquid
chromatographic instruments were manufactured by Waters and were controlled by separate
empower personal workstations.
the laboratory challenge centered on supporting quality testing for a large variety of
products with differing production timetables. chromatography testing on different
projects often required the development and utilization of different separation methods;
however, reliance upon un-networked personal workstation chromatographic systems
meant that it was necessary to manually
maintain projects and methods for each of
the 25 individual instruments. Hence, the
ideal solution to avoid the redundant manual
work was to convert the isolated empower
personal workstations into a single networked
chromatographic Data system (cDs) so
that developed methods were available on
appropriate HPlc and uPlc instruments.
Improving Laboratory Efficiency and Reducing Compliance Efforts With a Networked Chromatography Data SystemClient: erregierreTechnology: empower™ chromatography Data software (cDs)
Business Benefits
With the migration to the
Waters Empower CDS network
and by using the option of self-
directed software qualification,
Erregierre has been able to
increase their productivity,
improve regulatory compliance
adherence, and reduce costs.
Key benefits include:
■■ Increased efficiency in
method creation and
maintenance.
■■ Cost savings of 50,000
Euros per year.
■■ Reduced qualification and
validation efforts by 20%.
■■ Increased regulatory
compliance adherence.
■■ Increased data security.
13
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
14
Waters and uPlc are registered trademarks of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2012 Waters corporation. Produced in the u.s.A.July 2012 720004414en iH-PDf
compliance efforts have been significantly reduced because now
only one network cDs solution requires validation versus the
25 separate personal workstations that were required prior to
the migration. An additional observation has been made during
regulatory audits.
the backup of the chromatographic data is now done automatically
from the individual client systems to the empower server. this
automation of the process not only saves time but has also
increased data security. erregierre’s qualification and validation
efforts have been reduced by 20%.
After the implementation of the empower cDs network, erregierre
took an additional step to improve the lab efficiency. Waters®
Global services provided maintenance and qualification of the
chromatographic software and system. After deployment of
the empower cDs network, the staff received additional training
by Waters on performing periodical qualifications themselves
by using the Automated Qualification tool (AQt). AQt is an
electronic tool for empower that fully automates and simplifies the
qualification process for Waters chromatography and electronic data
management systems. With this training erregierre became self-
sufficient in their cDs qualification activities. they now perform the
tests four times a year, whereas previously they had only performed
qualification once per year. the time effort has remained the same,
but now they have the opportunity to update and cover more aspects
of the system. today Waters is still performing the maintenance of
the system, but by using the self-directed AQt, erregierre is now
able to qualify more systems in a more complete way, which
has led to time savings and increased confidence at the same
time. Additionally, they were able to achieve a cost savings of
50,000 euros per year.
Backing up chromatographic data represented an additional
challenge because utilizing isolated personal workstations
meant that the backups had to be done manually by saving data
on cDs or the intranet. this process was tedious and there was no
guarantee that all data were securely stored.
Working as a contract manufacturing organization (cmo) in
an international market, erregierre is subject to audits and
inspections by regulatory agencies and customers on a regular
basis. customer audits require that the laboratories spend
approximately one week per month focused on inspection and
related activities, such as preparation. While this is a necessary
part of doing business for a cmo, inspection activities are
time-consuming and considered non-value added with regards
to laboratory productivity.
THE SOLUTION
the decision was made to migrate from empower personal
workstations to an empower cDs network because the functionalities
of the network solution are suitable for erregierre’s chromatographic
quality testing application and regulatory compliance requirements.
they were also satisfied with the Waters’ unique range of service
offerings, including qualification for HPlc instrumentation.
tremendous efficiency gains have been achieved for the
chromatographic method development by using empower as a single
cDs network solution. once a method is created it can now be used
by all of the compatible chromatographic systems in service, which
has simplified their activities and increased productivity.
BACKGROUND
uK-based napp Pharmaceutical Group is part of a worldwide association of independent
companies. the company manufactures and markets innovative products in the areas
of oncology, respiratory, and pain management – with analgesia being their largest
therapeutic area.
one of napp Pharmaceuticals core values is innovation, which defines behaviors and
decisions within the organization and therefore drives strategies in the laboratory and
informatics environment.
At the site in cambridge, the Quality control (Qc) and stability laboratories perform the
required testing of raw materials, intermediates, and final release. A total of 22 people
are tasked with release and shelf life stability testing. the two laboratories are equipped
with 54 chromatographic instruments from multiple vendors where 34 of the 54 systems
consist of dissolution baths. the chromatographic data system (cDs) used in the two
labs is considered vital for achieving release of the products to market – and therefore
a key element in ensuring success of the entire organization.
CHALLENGE
the difficulties in managing and efficiently using different chromatography data
systems for chromatography and dissolution represented the largest challenge for
the laboratories. further adding to the complexity of operating separate cDs solutions,
the laboratory’s on-going data generation started to exceed the limits of the existing
file-based system data management process.
Besides the data management challenges, the use of excel for calculations and reporting
was an additional source of waste and variability in laboratory workflows. for example,
manual steps in documentation workflows provided the opportunity for errors due to
incorrect data transcriptions. furthermore, managers sometimes interrupted analysts
during testing to request access to reports.
in recent years, napp Pharmaceuticals’ success in the marketplace has translated
into greater product demand, which in turn led to the need for more sample testing
and reduced result turnaround times. Any delays in testing translated into delays
in product releases thus directly impacting revenue. since chromatographic testing
was recognized as vital for the product release process, management determined
Improving Quality Control and Stability Testing Efficiency with Standardized Chromatography OperationsClient: napp Pharmaceutical GroupTechnology: empower chromatography Data software (cDs)
Empower Software
provides a single
compliant-ready CDS
solution to improve
data management,
boost laboratory
productivity, and
reduce compliance risk.
15
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
16
Waters is a registered trademark of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2012 Waters corporation. Produced in the u.s.A.April 2012 720004312en ll-PDf
that a single compliant-ready cDs solution was required to
improve data management, boost laboratory productivity, and
reduce compliance risk.
in order to deliver a single compliant-ready cDs solution for the
laboratory operations of napp Pharmaceuticals, the it department
developed a plan to implement a commercial off-the-shelf
software (cots) package. the ideal solution would standardize
chromatography operations on a single comprehensive cDs
solution that included integrated data capture, analysis (including
automated calculations), and reporting.
for a forward-looking company such as napp Pharmaceuticals, the
new cDs system should not only satisfy the needs of today, but
also serve as a platform for the needs of future business growth.
T HE SOLUT ION
A dedicated team of four analysts was assigned to the cDs
implementation project. During the six months analysis phase,
the team identified data security and integrity as key aspects
of the project. Armed with vendor selection criteria, the team
chose Waters® empower™ chromatography software as their new
cDs standard. empower was identified as a complete solution for
data capture, data analysis (with automated calculations), and
flexible reporting in one platform. As future workflow needs
arise, empower offers a large variety of add-on options such as
Data Guard for database replication and enterprise Data manager
(eDm) for archiving and restoring empower projects.
With the comprehensive reporting capabilities of empower, the
team was able to replace other reporting tools, including excel.
managers now have better access to critical reports by logging
onto empower from their own computers without the need to
stop an analyst during a testing procedure. making use of Waters’
“train-the-trainer” concept, the project team has designed custom
training for their colleagues to fit the workflows that analysts
perform routinely.
An additional advantage of empower is its advanced technology
and the fact that it is based on an oracle database. it is considered
a complete but continuously evolving solution and therefore
a sound investment for the future. the selection process was
weighted heavily on the capabilities of the product, but the team
also valued the culture of innovation prevalent at Waters – one
which aligned well with napp Pharmaceuticals’ own culture.
BUSINESS BENEFIT S
standardizing on empower software has enabled napp
Pharmaceuticals Qc and stability laboratories to increase sample
throughput for product release. At the same time, it provides
a foundation for future chromatographic data handling needs,
enabling innovation – one of the core values of this organization.
Benefits include:
■■ easier sharing of data between the labs
■■ improved communication
■■ removal of transcription errors
■■ easier access to information
■■ reduced errors because of a smoother
and undisturbed workflow
■■ reduced bottlenecks in the lab workflow
■■ increased sample throughput without
compromising on release times
■■ flexibility in staff allocation
■■ reduced training costs
Chiesi wanted to speed up
and automate activities,
such as processing,
transcription, and cross-
checking of data, in order
to provide a more rapid and
reliable information system
that allows innovation and
interpretation of data
to take priority.
Every aspect of the laboratory
is designed to support science
and innovation. Chiesi’s Technology Research Laboratory, Chippenham, UK
BACKGROUND
chiesi farmaceutici is a privately owned international research and strategic innovation
focused company in the Pharmaceutical sector that develops and markets products in the
respiratory, cardiovascular and musculoskeletal therapeutic areas.
Part of corporate r&D, chiesi ltd. is a technology research laboratory in chippenham,
uK that became fully functional in 2009. chiesi ltd. has initiated cutting-edge research
in the field of inhalation delivery, with a special focus on pressurized systems. the aim
is to leverage and broaden chiesi’s technology capabilities and to find innovative ways
to deliver drugs to the lungs. in order to remain at the forefront of inhalation delivery
technology, chiesi is constantly examining new and existing technologies with a view
of enhancing the performance of current and future pipelines.
CHALLENGE chiesi’s technology research laboratory was created de novo with a long-term vision
of enabling innovation, while taking full control of all data without the need for role
segregation and specialist input. the entire laboratory staff of 12 people possess
flexible skill sets that allow them to run all laboratory equipment. Hence, every aspect
of the laboratory is designed to support science and innovation and minimize any
non-value added activities.
Supporting Innovation by Implementing a Lean Paperless LabClient: chiesi ltd.Technologies: nuGenesis® sDms, nuGenesis eln, empower™ 3 cDs, AcQuitY uPlc®
17
the laboratory was designed around the concept of a paperless
system for data capture, retrieval, and archive. An electronic
solution was sought to provide an alternative to paper-based
processes and disparate databases, which many of chiesi’s users
had experienced at previous companies. their aim was to speed
up and automate activities, such as processing, transcription
and cross-checking of data, in order to provide a more rapid
and reliable information system that allowed innovation and
interpretation of data to take priority.
Based on user requirements, data retrieval and collaboration were
two compulsory key functionalities. Hence, from a technology
perspective, they desired a solution that utilized a relational
database with a centralized server in order to facilitate easily
storage and location of data.
Another aspect was the compatibility of the proposed software
with their instrument hardware. the research laboratory
simultaneously acquired two AQuitY uPlc systems from Waters,
and several analytical balances from mettler toleDo, and had
recently added sartorius. Hence, these analytical instruments
needed to interface with their new software solution.
T HE SOLUT ION
Besides fulfilling the technical requirements, chiesi’s purchasing
decisions were driven by the capability of the software and
instrumentation solutions to streamline and simplify their
laboratory – based processes. the demonstration phase of
the instrument and software solution confirmed this and built
confidence within the team.
in order to achieve a paperless lab and to eliminate all non-value
added manual and paper based steps in the laboratory, they
selected the complete laboratory informatics solution from
Waters, that included empower cDs (chromatographic Data
software), nuGenesis sDms (scientific Data management system),
and nuGenesis eln (electronic laboratory notebook).
two AcQuitY uPlc systems with AcQuitY® sQD (single
quadrupole ms detection) running under empower were
implemented. each of the systems is equipped with sample
organizer, Binary solvent manager, sample manager, column
manager, PDA Detector and sQD. on one of the systems,
a coronaultra rs for charged aerosol detection was utilized, that
is also controlled by empower. in addition to the comprehensive
multi-vendor instrument control provided by empower, other key
functionalities of the networked empower software are the custom
fields and custom calculations that allow chiesi ltd to eliminate
isolated spreadsheets for any cDs related calculations.
for laboratory data management, nuGenesis sDms is interfaced
with all instruments in the laboratory, including uPlc®, balances
etc. Although empower is capable of managing chromatography
data, it was decided that all laboratory data should reside in a
single data repository. Hence, data and reports from empower
as well as all results generated by any other instrument are
automatically captured into nuGenesis sDms. Additionally,
all scientific documentation created internally or by external
collaborators is securely stored in nuGenesis sDms. this includes
reports and even scanned drawings. the automatic metadata
extraction capability enables the easy retrieval of any information
for collaboration.
the creation of electronic documents plays a major role in the
paperless environment. the potentially time-consuming process
of searching for data and manually transcribing it has been
replaced by automatic import of information from the nuGenesis
sDms repository into nuGenesis eln reports.
even though the chippenham technology research centre does
not work under GxP regulations, reviews/approvals and double
signatures are an integral part of their data system – the ability
to verify continuous processes, concept development, and project
progression is essential for intellectual property protection. the
signature process is fully integrated into the electronic workflow
to demonstrate the integrity of the data.
every member of the staff was trained by Waters: this was
identified as the most efficient method to cross-train the entire
team. Hence, with everyone equally trained on all equipment
and software, workflow bottlenecks were eliminated. shortly
following training, the staff confidently designed custom fields in
the empower cDs and templates for documentation in nuGenesis
eln – as a result, the team was able to utilize the solutions within
a short timescale.
18
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
BUSINESS BENEFIT S
the main goal of implementing a paperless lab by utilizing
Waters solutions was to prioritize innovation activities
at chiesi ltd. Key benefits include:
■■ With uPlc and empower, an example run time was reduced
from ten minutes to one minute while solvent consumption
was reduced approximately twenty-fold.
■■ By using uPlc, the lab required fewer instruments compared
to traditional HPlc – this translates to reductions in individual
system suitability checks, maintenance, waste, and occupied
lab space.
■■ use of empower software not only provides chiesi ltd with
increased efficiency and data integrity by reducing manual
calculations and transcription; but also enables rapid
identification of unexpected results by setting definable
thresholds within empower.
■■ creation of documents for experiments had previously been
a paper-based and manual process. entering information
electronically into nuGenesis eln templates and importing
data from the nuGenesis sDms database greatly reduced the
time spent on this activity.
■■ review and signature activities are performed easily and
quickly within the nuGenesis system by research peers. Due
to the automatic transfer of data, cross-checking has been
reduced to a minimum, freeing up time for scientific tasks
rather than non-scientific, time-consuming activities.
■■ Proof of scientific integrity as well as intellectual Property
protection is possible with nuGenesis eln.
■■ Basic method development can now be completed in
a few hours, entire feasibility studies in a markedly shorter
length of time.
■■ elimination of superfluous documentation tasks has
contributed to very positive employee morale, keeping
the turnover minimal and allowing the team to remain
agile by keeping the staff number low.
Waters, AcQuitY uPlc, uPlc, AcQuitY, and nuGenesis are registered trademarks of Waters corporation. empower and the science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2012 Waters corporation. Produced in the u.s.A.september 2012 720004448en Ao-PDf
19
The harmonization of the
CDS application installations
and introduction of Empower
has significantly increased
overall operational efficiency.
BACKGROUND
the client is engaged in the research, development, and production of generic human
medicines and in r&D of biotechnology-based medicines. With a vertical integration of
business units, their activities span from chemical development and production of active
substances to the pharmaceutical development, manufacturing, and packaging of finished
dosage forms. Products cover a large number of therapeutic areas that require complex
syntheses and sophisticated dosage forms. the company manufactures and sells products
in europe, as well as in the united states, south America, Australia, and other parts of the
world; hence, they must comply with regulatory requirements for the respective countries
where it sells products as defined by regulatory agencies such as the fDA, emeA, and tGA.
CHALLENGE
the analytical r&D, as well as production-related laboratories in the u.s. and europe
consisted of a diverse chromatography software landscape. most of the lc and Gc
instruments utilized specific workstation software from several different vendors. this
required a high training effort in order to ensure that individuals made optimal use of the
different systems. Due to number of software packages, keeping the different software
solutions current and validated was an additional challenge. finally, data management,
such as exchanging chromatographic information was very cumbersome since data was
stored on different drives, DVDs, and cDs. Additional information was contained on paper,
in microsoft excel, Word, Access, etc. furthermore Analytical services was often perceived
within manufacturing as the bottleneck during the batch release.
T HE SOLUT ION
in 2007, the client’s Analytical groups began investigating ways of increasing the
efficiency of u.s. and european laboratory operations in order to ‘do more with the same
people’ and ultimately reduce bottlenecks during batch releases. this strategy centered on
automating processes by introducing a laboratory information management system (lims)
and by harmonizing the chromatographic Data systems (cDs).
in addition, they required that the local cDs networks running at the different sites also
interface with the lims.
Increasing Lab Efficiency by Chromatography Data System HarmonizationThe client: A Generic Pharmaceutical company Technology: empower software
21
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
Waters and uPlc are registered trademarks of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2011 Waters corporation. Produced in the u.s.A.December 2011 720004172en Ao-PDf
the client selected Waters® empower™ chromatography software
for the cDs, since it was viewed as the industry standard that
undergoes continuous improvements of both standard and
add-on capabilities, such as third-party instrument control,
method validation, and method development. the software’s GmP
compliance technical controls and ability to control a wide variety
of uPlc®, HPlc, and Gc instruments from Waters, Agilent, and
shimadzu also weighed heavily in the decision. Also of critical
importance, the application programming interface (APi) allowed
empower to interface with the labWare lims.
An empower client server installation was introduced as
the company’s standard cDs in the Analytical research,
Development, and Quality control laboratories and was deployed
as independent networks for each site. All implementations
were deployed to satisfy regulatory requirements in a validated
environment for development and Qc. functionalities with
the largest impact from an efficiency standpoint included the
integrated e-signature process and the dissolution option, which
are considered necessities for a laboratory operating in a Generic
Pharmaceutical company.
the implementations at all sites have exactly the same
configuration for the regulated GxP laboratories, therefore the
documentation and validation overhead is streamlined. urs, iQ,
oQ, and PQ are the same at all regulated sites, which significantly
reduces the overall validation time and effort. Also, the empower
method Validation manager (mVm) software, which was
deployed in r&D, provides additional savings in time and
validation effort. Additional benefits of the empower software
implementation include the ability for the QA department to
modify standard operating Procedures (soPs), so that paper
reports are printed only at the very end of a completed testing
procedure versus throughout testing, as had been the case
previously, to increase analyst ease-of-use and align with
business sustainability practices.
BUSINESS BENEFIT S
the harmonization of the cDs application installations and
introduction of empower software has significantly increased
overall operational efficiency. Despite a heterogeneous mix of
projects in the different laboratories, their initial goal of doing
“more with the same people” was realized and the Analytical
departments experience much less pressure from their production
focused customers.
Benefits include:
■■ reduced data transfer and switching of applications
■■ reduced training and maintenance efforts
■■ reduced validation efforts
■■ easy exchange and availability of all chromatography-related
data and information within and between the different sites
■■ saving of paper and storage space
■■ compliant-ready software
■■ A reduction of bottlenecks during batch release
22
BACKGROUND
Dsm is a global science-based organization that is active in health, nutrition,
and materials. the company, which is comprised of 11 different business units,
delivers innovative solutions that improve performance in a broad range of global
markets. Dsm’s nutritional Products business is the world’s premier nutritional
ingredient manufacturer and supplier to producers of foods, beverages, and dietary
supplements. its product portfolio includes formulations for fat and water-soluble
vitamins, carotenoids for coloration, and novel nutraceuticals.
the nutritional Products business operates a manufacturing site in Belvidere,
new Jersey. the facility produces dry vitamin and mineral premixes, along
with liquid vitamin blends that are used in a variety of food and dietary supplement
products. Among other duties, the site’s Quality control laboratory is responsible
for verifying the composition of finished products and generating coAs (certificates
of analysis) for customers prior to shipment. Although the laboratory utilizes
a variety of analytical techniques for sample analyses, it relies principally on
liquid chromatography.
CHALLENGE
Dsm operates within a highly competitive industry, where it is critical to deliver
high quality products rapidly and cost effectively. Given the enormous production
volume at the new Jersey site, the Quality control laboratory must process
thousands of multi-analyte samples annually to confirm that final product is within
specifications. once a customer order is placed, analyses and corresponding coAs
must be completed as quickly as possible. Historically, laboratory workflow
had involved running an analysis method for a single vitamin on one dedicated
HPlc system – a process that was less than optimal.
in an effort to accelerate sample analysis turnaround time, reduce the cost of
analyses, and increase overall efficiency, the laboratory sought to enhance its
liquid chromatography-based capabilities. of critical importance to the Quality
control group was that any technology implementation be in alignment with
Dsm’s Quality vision.
Manufacturer Reduces Vitamin QC Analysis Times by Up to 90% Client: Dsm nutritional ProductsTechnology: AcQuitY uPlc H-class system and empower chromatography software
COAs can be generated
more rapidly ensuring
customers have the product
information they need as
quickly as possible.
23
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
Waters, AcQuitY uPlc, and uPlc are registered trademarks of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2011 Waters corporation. Printed in the u.s.A.July 2011 720003916en ll-AP
T HE SOLUTION
to meet their technological challenges and sustainability
objectives, the Quality control group purchased three of
Waters® AcQuitY uPlc® H-class systems with Photodiode
Array (PDA) Detectors and empower™ 2 chromatography
software. the AcQuitY uPlc H-class system provides the
flexibility of a quaternary-based HPlc with the performance
advantages of uPlc.® H-class enables users to continue running
existing HPlc methods or transition to uPlc separations using
integrated system tools and column kits that simplify migration.
since the implementation, the Qc group has transferred finished
product water and fat soluble vitamin assays from HPlc to the
uPlc H-class systems. All data acquisition and processing are
performed with empower software. this includes creation of a
standard report format to facilitate internal review by Qc analysts
and the use of empower’s custom calculations functionality to
generate customer-specific coA results.
“ The ‘Quality for Life’ vision at DSM Nutritional Products focuses on developing products and partnerships where the essential values of Quality, Reliability, Traceability, and Sustainability are critical. Waters UPLC Technology and Support services align with our values, and give us the confidence that we will continue to provide the world ‘Bright Science. Brighter Living,’ and remain the leader in providing nutritional solutions. I have worked with Waters Corporation for decades and found that their personnel and ‘green’ technology consistently support these values and help protect
our ‘Quality for Life’ promise to the world.”
TIM WELLS, Director of Quality, North America
BUSINESS BENEFIT S
By replacing traditional HPlc with AcQuitY uPlc H-class
systems, the Quality control laboratory at Dsm’s new Jersey
site has realized several benefits in key areas, including:
■■ laboratory productivity ■■ test procedures were consolidated from multiple HPlcs
to a single AcQuitY uPlc H-class system, creating
a more efficient workflow.■■ the time to analyze seven water soluble vitamins
in a single run has been reduced from 50 minutes to
5 minutes – a 90% decrease. ■■ the time to analyze fat soluble vitamins (A Acetate,
A Palmitate, and e Acetate) in a single run has been
reduced from 30 minutes to 3 minutes – a 90% decrease. ■■ the custom calculations and reporting capabilities of
empower software help to streamline data processing
and review. ■■ HPlc analysis methods can be rapidly transferred to uPlc.■■ lab personnel were able to master the use of uPlc H-class
and empower software quickly and easily. the group’s
senior scientist, who has used a variety of chromatography
software packages, indicated that empower was “the most
intuitive software out there”.
■■ customer satisfaction■■ coAs can be generated more rapidly, ensuring that
customers have the product information they need
as quickly as possible.
■■ “Green” operations■■ solvent use for liquid chromatography analyses has
decreased by approximately 70 to 80%; this supports
the company’s sustainability mission, and helps reduce
sample analysis costs.
24
25
Multi-Vendor Instrument Control Minimizes Training and Validation Efforts with Empower Software Client: A Global Pharmaceutical company
BACKGROUND
the Analytical research and Development group of a global pharmaceutical company is
responsible for early-stage product characterization method development and validation.
the laboratory is equipped with approximately 20 chromatographic systems from a variety
of instrument vendors including Waters, Agilent (lc and Gc), and shimadzu.
CHALLENGE
managing a large number of HPlc systems from multiple vendors can negatively impact laboratory
productivity and increase operational costs. the Analytical research & Development group must
address a number of challenges in order to maximize their original instrument investment, including:
■■ time and effort required to train analysts on multiple software packages■■ cost and risks associated with validating multiple software packages■■ traceability of analysis results back to the original instrument chromatographic conditions
T HE SOLUT ION
to provide comprehensive control over a broad range of
chromatographic modules and connect them to a versatile
chromatography data management tool, the customer employed
Waters® empower™ chromatography Data software (cDs) for data
acquisition, processing, reporting, and distribution. empower’s
open instrument Portal (oiP) technology allows vendors to
introduce instrument control without making changes to the
empower software. empower’s integrated relational database
allows the software to link to the chromatographic results with
the original method parameters.
third-party HPlc and Gc vendors who have leveraged the oiP
technology to deploy instrument drivers for empower include
shimadzu, Hitachi, Varian, Perkinelmer, and ctc Analytics.
26
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
Waters is a registered trademark of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2008-2010 Waters corporation. Printed in the u.s.A. september 2010 720002508en lB-AP
BUSINESS BENEFIT
relying upon empower software for complete control of all chromatographic systems allowed
the company to optimize the effectiveness of instrument related workflow.
High-impact benefits for both the laboratory and organization include:
■■ minimizing the training required for chemists to efficiently operate chromatographic software
that controls existing HPlc and Gc systems by standardizing on empower.
■■ eliminating multiple chromatographic software packages that would require additional
training and validation.
■■ Avoiding the new technology implementation and validation costs that would be incurred
if the chromatography software only supported a single vendor’s instrument.
■■ the ability to apply empower’s unique compliant-ready tools to all instruments and provide
a comprehensive audit trail with traceability back to the original instrument method
conditions, combined with advanced data security and processing capabilities.
■■ reducing the time and effort required for analysts to confirm data traceability with
empower’s integrated data collection and analysis capability.
■■ increasing laboratory productivity by standardizing procedures, reports,
and maintenance of all chromatographic systems.
27
Eliminating Chromatography Data Transfer to Spreadsheets: Reducing Errors And Improving Productivity With Custom Calculations Using Empower SoftwareClient: A Global Generic Pharmaceutical company
BACKGROUND
the Analytical Development group of a global generic pharmaceutical company is responsible
for late-stage analytical development. the group transfers a number of product characterization
methods required for batch release to the Quality control group, including those tests required
for content uniformity. the laboratory is equipped with approximately 100 HPlc systems.
scientists employ microsoft excel spreadsheets to perform a variety of calculations with the data
generated from the chromatography software. the results generated from these methods are
critical, as they will ultimately determine whether or not commercialized product is released and
how quickly the corresponding revenue can be realized.
CHALLENGE
the Analytical Development group must process large sample volumes as
efficiently as possible, while generating highly accurate results. in performing
the requisite chromatographic data calculations, the group faces a number of
challenges including:
■■ Data transfer and data transfer verification.■■ transcription and calculation errors.■■ each scientist spends one to two hours per analysis performing calculations.■■ time and cost associated with software training.■■ costs to develop and maintain macros to perform calculations.■■ software and macro verification and validation.
■■ A large number of very tedious calculations.
T HE SOLUT ION
to address the time, cost, and risk factors associated with developing testing
methods for batch release, the company employed Waters® empower™
chromatography Data software (cDs) for data acquisition, management,
processing, reporting, and distribution. utilizing empower’s custom calculation
functionality, the company was able to automatically process data and
integrate the information within empower software for easy review.
28
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
Waters is a registered trademark of Waters corporation. empower and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2008-2010 Waters corporation. Printed in the u.s.A. september 2010 720002507en lB-AP
BUSINESS BENEFIT
With empower software, the company is able to perform data acquisition and analysis
simultaneously in one integrated software package, thereby realizing a number of
high-value benefits, including:
■■ improved productivity by significantly reducing the time required for data transfer to
excel spreadsheets and its verification.
■■ using predefined tolerance levels, the software can detect out of spec values and
immediately halts problematic runs, saving the analysts’ time and reducing the cost
of solvent that would be wasted if the run were to proceed to completion.
■■ mitigating risk by reducing transcription errors.
■■ reducing the time and effort required for analysts to confirm data traceability.
■■ improved data integrity.
■■ reduced time and cost required for validation.
■■ improved overall laboratory workflow – the one to two hours required per analysis
to perform calculations was eliminated, allowing scientists to focus efforts in other
areas of the laboratory.
■■ With streamlined methods implemented in the Quality control group, testing is
performed more rapidly, facilitating batch release.
29
BACKGROUND
A global pharmaceutical company develops, manufactures, and markets dozens of prescription and over-the-counter drugs; the therapeutics
are used to treat disease conditions, including allergies, arthritis, cancer, diabetes, depression, heart disease, and HiV.
As part of its drug development and approval process, the company uses numerous analytical techniques for compound quantification,
purification, and characterization, including high performance liquid chromatography (HPlc). chromatographic method validation, the
process of establishing that the HPlc method is suitable for determining identity, quality, strength, purity, and potency of drug substances
and products, is a regulatory requirement.
Proper execution of method validation can facilitate compliance and pave the way for commercialization. unfortunately, the current process of
validating chromatographic methods is time-consuming and prone to errors, which not only negatively impacts productivity, but can also
ultimately delay the introduction of products.
CHALLENGE
the company’s multiple research and development businesses performed method validation
using a variety of tools with different capabilities that created process inefficiencies. in an
effort to synchronize method validation within the r&D units and manufacturing sites, the
company sought to implement an automated method validation solution that would incorporate
corporate-driven, template-based standard operating procedures (soPs) for managing validation
procedures, as well as providing a secure database to store results and enhance their ability to
adhere to 21 cfr Part 11 requirements.
even more important than the soP templates
that would guide the method validation
documentation process was the need to
ensure the accuracy and traceability of data.
the company wanted to enable analysts to
perform all method validation calculations
using the same chromatography data
software (cDs) they used to capture results.
this would eliminate the need to export
data to a spreadsheet for calculations, and
the potential for error in data transfer, and
simplify their validation efforts. the company
also sought to include data review and
approval functionality.
Streamlining Method Validation in Pharmaceutical Product Development with Empower Software Method Validation Manager (MVM)Client: A Global Pharmaceutical Company
A scientist with the
company’s R&D division
indicated that
Empower MVM provides
a 50% overall time
savings for non-sample
prep activities.
29
30
Waters is a registered trademark of Waters corporation. empower and the science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2006-2010 Waters corporation. Printed in the u.s.A.september 2010 720001522en lB-AP
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
T HE SOLUT ION
the company selected Waters® empower™ software method
Validation manager (mVm) as the single, comprehensive solution
to satisfy all of its method validation requirements. empower
mVm is an enterprise option for the market-leading cDs platform
that addresses the limitations and bottlenecks faced
in chromatographic method validation.
With Empower MVM, analysts at the company now have the
ability to:
■■ incorporate established soP parameters within the cDs software
■■ Display the status of ongoing validation studies to guide the
user through the workflow
■■ Preemptively associate injection data to validation characteristics
■■ Automatically check data to confirm that each validation
parameter adheres to soP requirements
■■ Approve data at various steps in the workflow
■■ Perform all validation results and statistical calculations
in empower
■■ Perform multi-component analyses and batch processing of results
■■ Alert users to results that are out of specification
■■ Generate reports with standardized templates
empower mVm also assists the company in regulatory compliance
by providing audit trails, tracking injections for each validation
test, designating privileges to control user activity, and securing
traceable data within the empower 2 database.
BUSINESS BENEFIT
By implementing empower mVm, the company has automated and
significantly streamlined the method validation process.
A number of factors have contributed to an increase in overall
productivity, including:
■■ eliminating the need to transfer data to third-party software
packages for statistical calculations and reporting.
■■ reducing transcription errors and the time spent identifying
those errors.
■■ Providing inexperienced analysts with soP templates,
eliminating the need to continually refer to complex
and lengthy written protocols.
■■ the ability to manage a validation study is now cooperative
effort since each individual involved in the process can determine
what activity has completed at any time in the workflow.
A scientist with the company’s global r&D division indicated that
nonsample prep activities account for approximately 60% of the
time consumed in a method validation study. With empower mVm, he
estimates this could be reduced to as little as 10%, representing a
50% overall time-savings, as shown in table 1. Just as importantly,
the scientist said that with empower mVm, he is “more confident that
his method validation data is accurate and traceable.”
Validation task % Total validation time Time-savings with Empower 2 MVM
Administrative 20 75
sample prep 40 0
Processing data 20 95
report Generation 20 80
Total 100 50
Table 1. Method validation time savings with Empower Method Validation Manager.
31
nuGenesis PlAtform
32
33
Improving Data Accessibility And Intellectual Property Management with NuGenesis SDMSClient: Pharmaceutical Division of a Global Health care company
“ The solution needed
to integrate a large
corporate archive of
critical data and make
it available through one
online user interface.”
BACKGROUND
the pharmaceutical r&D division of a global healthcare company focuses on the development and
commercialization of therapeutics used in the treatment of mental illness, neurological disorders,
gastrointestinal disorders, fungal infections, allergies, and cancer. An innovator, the company
has developed dozens of drugs since its inception. the company operates a number of analytical
laboratories that utilize automated systems to analyze large volumes of samples for internal clients.
A solution was needed to integrate a large corporate archive of critical data and make it
available through one online user interface. Additionally, the solution had to integrate with
their corporate global compound registry system (Gcrs).
CHALLENGE
to satisfy electronic data management requirements for its analytical laboratories, the customer
faced a number of challenges, including:
■■ the extensive use of automated systems and robotics presented complications for
automated result distribution; often, each separate well plate is a measurement for
a different internal customer, and is therefore handled separately.
■■ Analyses have significant relevance for intellectual property protection; all patent-relevant information
had to be harvested automatically in case results that needed to be retrieved on short notice.
■■ With an open access workflow, the company needed to move from labor-intensive, lims-oriented
laboratory practices to an open, all-electronic system for scientific data management.
T HE SOLUT ION
the customer facilitated the transition to an open access workflow by implementing a number
of Waters® laboratory informatics solutions, that included the following components:
■■ NuGenesis® Scientific Data Management System (SDMS): Automatically imports disparate
data generated from instruments, scientists, and outside sources into a centralized data
warehouse. information can be searched, communicated, and shared among scientists,
thereby facilitating laboratory efficiency, regulatory compliance, and product development.
■■ MassLynx™ Software: Provides mass spectrometry data acquisition and analysis. Data
processing capabilities include application managers – software that assists with the
acquisition of application-specific data and the conversion of that data into useful information.
■■ OpenLynx™ Application Manager: Provides open access, walk-up lc/ms system operation,
as well as customizable batch processing to support the large amounts of data resulting from
high throughput analyses.
34
the solution impacted a number of areas.
Batch reports for LC/MS analyses
the customer uses automated systems to process large volumes
of samples. in many cases, the results must be extracted
from individual well plates separately. this data processing
requirement was addressed by utilizing the nuGenesis sDms Print
to Database functionality. Printed results (the actual content of
instrument-generated reports) provided by masslynx software are
automatically captured in a centralized database, where they are
indexed, made searchable, and can be shared.
Individual reports for LC/MS analyses
the open access analytical laboratory emails the results of lc/ms
analyses directly to the originator in the form of an openlynx
report file. if the compound must be registered, the user can use
Print to Database to archive the results. for u.s. sites, all data are
now automatically archived with no user discretion allowed. in
addition, a template was configured to harvest all patent-relevant
information from the customized openlynx template.
Accessibility of critical data in medicinal chemistry
A global project in medicinal chemistry had naming conventions
for all methods. A vast amount of historical data has now been
uploaded onto the nuGenesis sDms Platform from the legacy
system (almost 90,000 records on VAX/Vms). custom templates
were generated for the process of extracting critical data. search
and reporting functions within sDms enable analytical laboratory
managers to generate matrix views that correlate analytical
techniques to their respective sample analysis. this task had
previously been impossible on the legacy systems.
Global compound registration integration
the company’s Gcrs was integrated with nuGenesis sDms.
this integration allows for batch job synchronization between
sDms and Gcrs systems, allowing management to ensure that
the essential analytical data is also being archived to support a
structure registration in the Gcrs.
BUSINESS BENEFIT
the customer realized a number of benefits from their Waters
laboratory informatics implementation including:
■■ migration to a less labor-intensive open access laboratory
environment which, in turn, helped address the challenge
of staff reductions.
■■ requests from the Patent department often arrive months
after the analysis. By leveraging the tight integration between
nuGenesis sDms and microsoft office products, it is now
possible to use an excel spreadsheet of registry numbers to
look up data in the sDms archive. regardless of how much time
has passed, critical intellectual property information can now
be accessed quickly and easily.
■■ Analytical data from third-party instrumentation have been
integrated within nuGenesis sDms, with specific fields
available for critical sample information such as purity,
retention time, molecular ion, analytical method files, etc.
■■ the accessibility of all analytical data has improved the flow
of drug candidate information between the customer’s
discovery, development, production, and quality control
groups. A well-connected product development lifecycle has
yielded gains in efficiency and reduced the time required
for commercialization.
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
Waters and nuGenesis are registered trademarks of Waters corporation. masslynx, openlynx, empower, and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
Waters nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.
©2006-2010 Waters corporation. Printed in the u.s.A. september 2010 720001461en lB-AP
35
Employing a Bioanalytical Data Management System to Increase Workflow Efficiency Client: A global pharmaceutical companyProduct: nuGenesis® scientific Data management system (sDms)
The amount of paper
generated per run has
been reduced by 90% –
a savings of 56,000 sheets
of paper at a single site.
BACKGROUND
the client is a global health care company focused on patient needs, and they
offer a range of essential health care assets. the company discovers, develops,
and markets a variety of innovative therapies worldwide. extensive research and
development efforts are focused largely on health care challenges in oncology,
diabetes and metabolic disorders, as well as thrombosis, internal medicine,
central nervous system disorders, and vaccines.
CHALLENGE
A recent merger combined numerous laboratories and scientific processes,
including those groups involved in bioanalysis. After the merger, the company’s
bioanalysis laboratories employed three different systems to manage analytical
data. the systems included Perkinelmer’s sQl*lims, thermofisher’s sample
manager, and innaphase’s (now thermofisher) Watson lims. the typical workflow
that resulted, including sample handling and analysis documentation, proved to
be less than optimal. challenges included:
Compliance management
■■ 21 cfr Part 11 compliance was inconsistent from site to site.
Paper-centric legacy processes
■■ filling out, reviewing, collating, moving, and storing paper records
was very time consuming.
■■ mining information from the paper records was difficult and inefficient.
Operating costs
■■ each analytical run produced 70 to 100 sheets of paper.
Annually, nearly 100,000 sheets of paper were printed and stored.
in addition to streamlining workflow, it was the desire of the bioanalysis groups to
significantly reduce the amount of paper generated and stored during the course of
standard operations.
36
SOLUT ION
Bioanalytical data management system
to reduce the volume of paper generated and increase overall workflow efficiency, the company implemented a bioanalytical data
management system comprised of the following:
NuGenesis SDMS
■■ With Waters® nuGenesis sDms, data from a wide variety of
sources, including instruments and analysts, can be readily
imported and indexed within a centralized electronic data
warehouse. once collected, this information is easily
searched, communicated, and shared.
■■ All lc/ms/ms data from bioanalysis studies, including printed
reports, are stored in nuGenesis sDms. the ms systems are
from multiple vendors.
■■ Peak areas and final reports are exported from nuGenesis
sDms directly into Watson lims.
■■ After a study is completed, all electronic data is securely
archived according to GlP regulations using the electronic
signature functionality of nuGenesis sDms.
Watson LIMS
■■ A specialized, protocol-driven lims designed to support
bioanalytical studies in drug development
■■ Watson lims contains all the information about the design of
a study, including subjects, treatments, timings, and samples.
it also contains the logistic information and bioanalysis run
information, as well as the final concentrations.
The QA review process – before and after Before the bioanalytical data management system:
■■ Analysts collated all paper run reports, sample logs, lims
printouts, and final reports. material was then physically
transported to Quality Assurance (QA).
■■ QA audited the reports, and eventually provided a final signed-
off report – this process required a minimum of five days.
After the bioanalytical data management system:
■■ the QA analyst receives a printed copy of the report and audits
against electronic records and the report from Watson lims to
ensure data transfer has been performed correctly.
■■ Approvals are done electronically using the built-in function
of nuGenesis sDms, and no longer require handwritten
signatures on paper reports.
With NuGenesis SDMS, data from a wide variety
of sources, including instruments and analysts,
can be readily imported and indexed within a
centralized electronic data warehouse.
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
BUSINESS BENEFIT S
the client’s bioanalytical laboratories have realized significant gains in workflow efficiency, as well as cost reductions through the
implementation of a bioanalytical data management system. Benefits include:
Greater productivity
■■ review steps for analyst, checker, and principal investigator
have been eliminated. the reduction in Qc review time has
saved approximately 45-man days per year for the eight-
person team.
Reduced costs
■■ the amount of paper generated per run has been reduced
by over 90% – a savings of 56,000 sheets of paper at
a single site.
Validation effort
■■ By using a standard rollout/configuration, validation has
been simplified, and is performed only once.
■■ leveraging vendor validation services, as encouraged by
GAmP5, has further reduced the time and effort required
for validation.
Compliance management
■■ the automatic capture and securing of instrument data, final
reports, and lims data by nuGenesis sDms have assisted the
company’s laboratories in meeting regulatory requirements.
37
Waters and nuGenesis are registered trademarks of Waters corporation. the science of What’s Possible is a trademark of Waters corporation. All other trademarks are the property of their respective owners.
nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.
©2010-2012 Waters corporation. Produced in the u.s.A.march 2012 720003236en lB-PDf
38
INCREASING EFFICIENCY IN MANUFACTURING QUALITY CONTROL WITH NuGENESIS SDMS Client: Waters Corporation, Liquid Chromatography Column Manufacturing Facility
BACKGROUND
Waters corporation operates a liquid chromatography column manufacturing facility in Wexford,
ireland that produces over 95% of all columns sold by Waters. the department employs
approximately 70 people, including six production support analysts and two chemists.
facility production volume is up to 5,000 units per week, and includes Waters® symmetry,®
Atlantis,® Xterra,® AcQuitY,® and XBridge™ column brands. column packing materials are supplied
by another Waters manufacturing facility located in taunton, massachusetts. columns are used
for both Waters and third-party liquid chromatography systems, and are shipped to thousands of
customers in locations around the world.
CHALLENGE
A critical step in the column manufacturing process is the review of outgoing customer orders
prior to packaging and shipping. the reviewer’s primary responsibility is to inspect product
quality and associated paperwork; however, reviewers are also required to manually enter data
for 14 categories of column detail information, such as efficiency, back pressure, retention time,
batch number, part number, serial number, etc. in total, 56,000 manually transcribed entries
are made per week – a laborious, time-consuming process. in addition, all column detail data are
archived on DVD’s. Accessing this information for customer inquiries regarding products in use
may require up to 2 hours of the analyst’s time, potentially reducing productivity and increasing
response time.
The time for a reviewer
to input product data for
one 96-piece customer
order has been reduced
by 50%... reviewers
are able to focus even
more time on quality
improvements.
39
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
T HE SOLUT ION
in september 2006, the Wexford facility implemented Waters
nuGenesis® scientific Data management system (sDms). With
sDms, data from a wide variety of sources, including instruments
and analysts, can be readily imported and indexed within a
centralized electronic data warehouse. once collected, this
information can easily be searched, communicated, and shared.
in the Wexford application, sDms interacts with Waters’ empower™
chromatography software via its Print-to-Database functionality
– as reviewers print column test chromatograms, sDms
automatically catalogs and captures the pertinent information,
and saves it to the database. information on the column, including
a hyperlink to the corresponding chromatogram, can be instantly
retrieved anytime, from multiple geographic locations.
BUSINESS BENEFIT
the implementation of sDms has afforded a number of benefits to
the Wexford facility’s order fulfillment workflow, including:
■■ Risk reduction – the automatic capture of column detail information with sDms has reduced the data entry error rate to nearly 0%. During the Print-to-Database operation, a template ensures that all relevant indexing information is captured for each chromatogram, thus providing automated error proofing.
■■ Greater productivity – the time for a reviewer to input product data for one 96-piece customer order has been reduced by 50%.
■■ Better quality – With less time required for data entry, reviewers are able to focus more time on quality improvements.
■■ Process optimization – sDms provides rapid trending of column test data. results are instantly accessible to the Waters taunton facility staff, which allows them to make any necessary adjustments during the packing material production process, and optimize column performance specifications. the end result is an improvement in batch-to-batch reproducibility and delivery of a consistently performing product.
■■ Enhanced collaboration – electronic storage of column performance records means that data can be easily shared between the taunton and Wexford facilities on a 24/7 basis.
■■ Faster customer service – By simply entering a particular
serial number into sDms, an analyst has instant access to
archived column Qc data. customer inquiries on column
performance can be addressed immediately, which helps
minimize disruptions to the customer’s workflow.
Waters, symmetry, Atlantis, Xterra, AcQuitY, and nuGenesis are registered trademarks of Waters corporation. XBridge, empower, and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
Waters nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.
sDms Vision Publisher is covered under a formal Quality management system certified by the tÜV rheinland Group.
©2008-2010 Waters corporation. Printed in the u.s.A. september 2010 720002857en lB-AP
40
41
Improving Data Management and Accessibility Across Multiple Geographies with NuGenesis SDMSClient: A Global technology-Based manufacturing organization
BACKGROUND
the technology division of a global plastics manufacturer has several hundred employees
working in six business divisions located in north America, europe, and Asia. like many
scientific organizations, the customer found it challenging to manage, transfer, review,
and report technical data and information across multiple geographic locations.
CHALLENGE
the technology division is comprised of product developers, platform chemists, analytical
chemists, and technicians located at eight different sites worldwide. single-point instrument
data were captured electronically and stored in a lims; multi-point data were often stored in
paper format. reports and presentations had different storage formats and sites. Historical
knowledge was difficult to access globally – sometimes it was lost entirely.
T HE SOLUT ION
to address this challenge, the customer chose to implement Waters® nuGenesis® scientific
Data management system (sDms). nuGenesis sDms automatically captures data from various
applications as either raw data, or as a printed report, and builds a catalog containing metadata
(data about the data). Any authorized user can access the data (chromatograms, spectra, and
reports) via a web-based browser. the modular architecture of the sDms system lends itself to
customization to suit business needs.
What dictates the system architecture?
to minimize the impact on speed, a single server was ruled out. operational centers in north
America, Asia, and europe were designated as sites for regional servers. each site connects to
all three servers through one interface.
Who supports the system?
there is a global help desk. A global administration team from the customer’s technology
function, not it, oversees system support.
What is the best way to ensure that features map to business-critical systems?
two stages of data modeling ensured that the system would meet the requirements of the user base.
it was critical that the system meet user expectations at launch so that the users could see the time
savings and immediate benefit.
“ We found that
teaming with Waters’
experts and good
up-front planning
were critical to
our successful
implementation.”
42
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
Waters and nuGenesis are registered trademarks of Waters corporation. t he science of What’s Possible is a trademark of Waters corporation. All other trademarks are the property of their respective owners.
Waters nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.
©2006-2010 Waters corporation. Printed in the u.s.A. september 2010 720001451en lB-AP
the first data modeling stage was a big-picture analysis of how the
system would function; the second stage dealt with views, privileges,
soPs, and templates. in addition, planning was necessary for lims
interfacing and password synchronization among three servers.
the customer found that one of the most valuable facets of the
data modeling experience was having a Waters system engineer
assist during the data modeling session. the customer found that
teaming with Waters’ experts and good up-front planning were
critical to their successful implementation.
How does Waters ensure long-term system sustainability?
measuring how many documents are printed and archived per
business and per site, as well as monitoring retrieval statistics
allow maintenance, upgrade efforts, and refresher training to
be directed to the appropriate sites and/or business units.
the total number of print data records grew from 8,144 in the first
full quarter after implementation to 142,000 by the end of the
third quarter. roughly 55% of those records came from migrating
legacy repositories into sDms to make them text searchable;
38% were laboratory data, and 7% included other reports and
project documentation.
What was the biggest lesson learned during implementation?
it was important to spend several months populating the system
with legacy data before rolling out the application. this enabled
the customer to verify the data model, and provide a base
repository supporting initial activities. Doing this made nuGenesis
sDms a tool that users wanted to use daily as soon as it was
available, as opposed to being trained on a relatively empty
system where they wouldn’t see immediate benefits.
BUSINESS BENEFIT
By tracking and categorizing one week of activities into value-added
categories (research, notebook documentation, and writing papers)
and non-value-added categories (managing paper files, looking for
data, faxing, and email data), the customer determined that they
could realize a 10% time savings globally by using nuGenesis sDms.
Additionally, the customer calculated that the number of paper
records that could not be located after several years, and the
calculated fraction of the analytical budget used to generate those
data were enough – together with the activity mapping – to justify
their investment in nuGenesis sDms.
other benefits that resulted from the nuGenesis sDms
implementation include:
■■ increased speed of new product introduction.■■ leveraging global talent and bringing new sites up to
speed more quickly.■■ reducing transcription errors with paperless laboratories.■■ instant availability of multi-point data.■■ enabling transparent, consistent global processes.■■ the ability to work across time zones.■■ Avoiding work redundancy.
■■ People locating data themselves rather than submitting a request.
implementation of a nuGenesis sDms data repository created a
paradigm shift in the way that this large, global technology-based
manufacturing organization has been able to archive and communicate
technical data. A solid implementation enabled the customer to reap
many benefits, from cost-out productivity of streamlining processes
and reducing the time spent on managing data, to sharing important
information and knowledge with scientists around the world.
43
21 CFR PART 11 Compliance with NuGenesis SDMSClient: A Biopharmaceutical Company
BACKGROUND
A us-based biopharmaceutical company is engaged in the discovery, development, and
commercialization of medicines used in the treatment of diabetes, obesity, and cardiovascular disease.
the company is primarily focused on investigating the potential utility of
new peptide hormone candidates, and has significant research and clinical
expertise in metabolic medicines. they have developed a proprietary
library of novel synthetic polypeptides to identify and characterize the
activity of both known and unknown peptides.
the company has a number of therapeutics in various stages of clinical
development and is subjected to continual regulatory scrutiny.
CHALLENGE
to satisfy us fDA regulatory demands, the company must comply with 21
cfr Part 11 guidelines for the backup and archival of critical laboratory data.
specifically, they required a data management solution that allowed for
document lock-down and revision control for microsoft excel spreadsheets.
their process involved manually transferring data from paper reports to
excel spreadsheets. the spreadsheets required 100% quality verification
to ensure the integrity of the data. this verification process was very labor
intensive and prone to transcription errors, all of which had to be identified and corrected.
T HE SOLUT ION
the company selected the Waters® nuGenesis® scientific Data management system (sDms) for
its ability to automatically import disparate data generated from instruments, scientists, and
outside sources into a centralized information warehouse. With nuGenesis sDms, data can be
easily searched, communicated, and shared among scientists, thereby facilitating laboratory
productivity, product development, and regulatory compliance.
Waters’ enterprise software solutions (ess) team worked closely with the customer on all aspects of
the nuGenesis sDms application deployment. the deployment consisted of the following components:
■■ File Capture – Allows any kind of file data to be automatically captured, cataloged, and secured.
■■ Print Capture – Allows print data (the actual content of instrument generated reports) to be
captured, indexed, and secured in high fidelity.
44
■■ UNIFY templates – extracts valuable data from captured printouts
for cataloging and later retrieval.
■■ Auto Extraction templates – Automates search and extraction
of pertinent data, and the exportation of the data to external
applications for additional calculations.
■■ Application Control Manager (ACM) – Provides a secure,
compliant framework for using microsoft office applications,
including Word, excel, and PowerPoint.
■■ Software Development Kit (SDK) – for custom programming
using nuGenesis sDms functionality, such as specialized
integration with legacy software.
the system was configured and data modeled to support multiple
file capture and Print capture applications types.
Waters was responsible for the execution of the installation and
operational Qualification (iQ and oQ) workbooks, which test
the installation and operation of the base system. Waters also
provided customized Performance Qualification (PQ) scripts that
test business processes, and verify that the appropriate standard
operating procedures (soPs) are in place, to ensure that the
system meets the requirements for its intended use.
A driving force for implementing nuGenesis sDms was its
seamless integration with microsoft excel. the solution’s
functionality gave the company the ability to control and extract
data to excel spreadsheets with the highest confidence.
Waters’ ess team partnered with the customer to define
the requirements for the Auto extraction templates to
support Analyst and softmax Pro reports. this enhancement
gave the company the ability to extract the maximum number
of data points required into excel.
Waters coordinated the creation of the functional specifications,
product development, testing, and iQ/oQ/PQ for the installation
and validation testing of the Auto extraction enhancement.
BUSINESS BENEFIT
this biopharmaceutical company is 21 cfr Part 11 compliant in
their labs for backup, archival, and retrieval of critical clinical and
pre-clinical data. With the nuGenesis sDms solution, they have
dramatically improved their ability to control validated spreadsheets.
the scientists can transfer data automatically to the controlled excel
spreadsheets without requiring data quality verification.
the use of Auto extraction for Analyst and softmax Pro reduced
turnaround time from 30 minutes per report for manual entry,
to one minute for the automated solution. on average, this has
reduced the time required for data entry by more than five hours
per week. now the company’s quality department can perform spot
audits of the data, rather than the 100% verification after manual
data entry.
the company plans to deploy nuGenesis sDms in all of its labs.
Application control manager (Acm) will be used to control
validated spreadsheets. Additionally, Acm will be used to
control an electronic laboratory logbook.
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
Waters and nuGenesis are registered trademarks of Waters corporation. t he science of What’s Possible is a trademark of Waters corporation. All other trademarks are the property of their respective owners.
Waters nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.
©2005-2010 Waters corporation. Printed in the u.s.A.september 2010 720001358en lB-AP
45
BACKGROUND
A large generic pharmaceutical company has research, development, manufacturing, and
distribution operations worldwide, including north America, south America, europe, Asia,
and Australia.
the company’s ongoing goal is to maximize return on investment in r&D by reducing the time
required to develop and commercialize new products.
A number of strategic initiatives were launched to achieve this goal, including the implementation of
Waters® laboratory informatics solutions. Waters nuGenesis® scientific Data management system
(sDms) plays a vital role in automating scientific data entry into the company’s electronic common
technical Document (ectD), a standard electronic format for regulatory submissions.
the ectD is an advanced method used by pharmaceutical companies to assemble and submit
regulatory submissions to regulatory bodies around the world, including the us fDA, Health
canada, Japan’s ministry of Health, labor and Welfare; and the european union’s european
medicines Agency.
this represents a unique set of challenges for electronic record and data management. Data and
records must be archived in a compliant, secure database that protects the integrity of e-records
from tampering and loss throughout their relevant retention periods.
CHALLENGE
the company required an electronic solution that provided information management capabilities
that were superior to legacy paper documentation and workflow archiving. the solution
needed to address a number of key business drivers, including:
■■ securing new product exclusivity by optimizing the regulatory submission process■■ responding to regulatory and industry initiatives by implementing common standards
for e-submissions and e-information exchange■■ maximizing return on investment in r&D■■ reducing product development and commercialization time
■■ increasing productivity and efficiency while decreasing costs
T HE SOLUT ION
the company selected nuGenesis sDms as the cornerstone of its strategic initiative to establish
a worldwide corporate information management, exchange, and submissions system.
SDMS plays a vital role in
handling scientific data
entry into the company’s
electronic Common
Technical Document
(eCTD) for regulatory
submissions.
Optimizing Efficiency with Electronic Regulatory Submissions with NuGenesis SDMSClient: A Generic Pharmaceutical company
46
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
Waters and nuGenesis are registered trademarks of Waters corporation. the science of What’s Possible is a trademark of Waters corporation. All other trademarks are the property of their respective owners.
Waters nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.
©2005-2010 Waters corporation. Printed in the u.s.A.september 2010 720001359en lB-AP
their electronic regulatory submissions project, initiated in 2001,
employed an integrated software solution that combined several
core applications:
■■ Waters NuGenesis SDMS: Automatically imports disparate data
generated from instruments and outside sources into a centralized
data warehouse. information can be searched, communicated, and
shared among scientists, thereby facilitating laboratory efficiency,
regulatory compliance, and product development.
■■ Broadvision One-to-One Document Management System:
Provides content management of business documentation in
microsoft office formats and Xml with e-signature workflow,
and integrated PDf and web publishing.
■■ Lorenz docuBridge: combines content collected by nuGenesis
sDms and Broadvision in an ectD document for submission.
the nuGenesis sDms implementation began in early 2002.
the first phase of the deployment concentrated on four north
American sites and was completed in less than two years.
of primary interest to the customer was the utilization of the sDms Print
capture technology, which captures, indexes, and secures the actual
content of instrument-generated reports. the company relies on Print
capture for scientific data capture, metadata extraction, and archival
from a variety of data sources, including Perkinelmer’s totalchrom
chromatography software, Agilent’s chemstation and chemstore
chromatography software; lims, and other supporting systems.
During the software integration phase, Waters’ enterprise
software solutions (ess) group worked closely with a cross-
functional team that included the company’s corporate regulatory
operation and it departments. the Waters ess team provided post-
deployment business and technical support, as well as maintenance;
incorporating critical feedback from the customer to ensure
continuous improvement.
the successful validation of key software solutions is an essential
component of any major deployment. the validation for this solution
consisted of two stages: first, the core applications, and second,
the individual site-specific rollouts. timelines were 7 months for
the core application iQ/oQ, and 4 to 11 months for the iQ/PQ
site-specific data configuration.
BUSINESS BENEFIT
nuGenesis sDms now plays a vital role in handling scientific data
entry into the pharmaceutical company’s electronic common
technical Document (ectD) for regulatory submissions. the
ability to be the first to register and obtain approval for a new
pharmaceutical product yields six months of exclusivity and
significantly enhances revenue potential.
moving to an all-electronic scientific and business information
management strategy that facilitates workflow for laboratory
scientists making their final regulatory submissions has yielded
great gains in efficiency.
the availability of scientific data through nuGenesis sDms has
increased the company’s productivity, and serving as a single point
of access for all information regardless of geography, sDms has
helped the company substantially reduce their operational costs.
finally, in an environment of increased scrutiny by global
regulatory inspectors, the company has enhanced its competitive
and strategic positioning by improving its ability to readily
satisfy compliance.
collectively, these benefits have allowed the customer to reduce
product development and commercialization times.
47
Optimizing Image Data Processing and Storage for Drug Development with NuGenesis SDMSClient: A Pharmaceutical Division of a Global Health care company
BACKGROUND
A pharmaceutical subsidiary of a global healthcare company is focused on the development
and commercialization of therapeutics that are used for treating mental illness, neurological
disorders, gastrointestinal disorders, fungal infections, allergies, and cancer. An innovator,
the company has developed dozens of drugs since its inception.
to support their discovery and development efforts, the company uses a number of analytical
techniques, such as multi-mode high throughput screening (Hts) in well plate microscopy
systems. these systems are typically used for target identification, target validation, assay
development, Hts, hit-to-lead, deep pharmacology, and ADmet analysis. the vast amount
of data produced is typically generated in the form of electronic images.
CHALLENGE
the customer needed to support image-driven research in a medium-to-high data
throughput environment.
managing the capture, storage, and retrieval of large volumes of image data can present a
variety of problems for pharmaceutical organizations. secure information storage can be
cost prohibitive unless the system is well designed, and the business benefits are prioritized.
using numerous localized DVD/cD backups for data storage limits the accessibility of this
valuable information, preventing full utilization of a corporate resource.
“The scientific image
data management
system deployment
has revolutionized
the company’s
ability to process
and store large
amounts of
image data at
acceptable costs.”
SYSTEM
ADMINISTRATOR,
GLOBAL HEALTH
CARE COMPANY
47
48
THE SOLUTION
the customer implemented Waters® nuGenesis® scientific
Data management system (sDms), which automatically imports
disparate data generated from instruments, scientists, and outside
sources into a centralized data warehouse. information can be
searched, communicated, and shared among scientists, thereby
facilitating laboratory efficiency, regulatory compliance, and
product development.
for this implementation, the nuGenesis sDms Platform was
combined with a customized user interface and a carefully
developed and tested raw data file archiving strategy. the solutions
comprise a scientific image data management system (siDms).
this siDms provides optimal support for working with image data – from
local workstations to a customized, unified workbench environment –
that relies on gigabit network connectivity between building blocks.
Key to this successful deployment was its integration with an
affordable alternative for managed storage of large quantities of
images: Advanced Digital information corporation’s (ADic) total
data lifecycle management system.
With the ADic system, data are captured from multiple operating systems
that are connected to multiple devices via the storage area network.
original data files are captured and indexed by the nuGenesis sDms
automated file capture agent; sDms provides central data management
of the online and archived data. the platform’s offline storage manager
(osm) provides this control to an ADic storage area network and tape
library system. A customized unified workbench then facilitates the
retrieval of desired files from the archive to a local workstation. this
restoration service is robust and takes advantage of the high-speed
network between the individual components of the solution.
Because of the large volume of data, the network was upgraded to
a dedicated one GB network between client computers, servers, and
their offline storage systems. the sDms software Development
Kit (sDK) was used to develop custom integration tools to
interface with ADic library software. special functionality was
included for uploading and downloading large image datasets.
iterative tests on 800 GB of data yielded a performance of 5 GB
per hour net capture of file data to the ADic library system, and
7 GB per hour net retrieval from the ADic system to the client.
Assuming a 50% uptime, the system provided capture and
restore capabilities of 400 GB per week, and 600 GB per week,
respectively.
BUSINESS BENEFIT
the scientific image data management system deployment has
revolutionized the company’s ability to process and store large
amounts of image data at acceptable costs. the combined
nuGenesis sDms-ADic technology can be leveraged for virtually
any type of scientific data. Benefits include:
■■ elimination of decentralized and unmanaged DVDs/cDs
■■ Added value to major investments in image acquisition
and processing infrastructure
■■ Providing data from service labs to client research
departments is simple and flexible
■■ offline image data processing, which enables the company to
increase its Hts capacity, as well as its ability to gain new
insights into results by reprocessing image sets
the Waters nuGenesis sDms-ADic strategy to build a siDms
solution has provided the customer with a unified workbench that
delivers image data to the fingertips of the researcher. robust
services transparently manage the end-to-end data flows, with
functional and performance tests exceeding the initial objectives
of data security and throughput.
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
Waters and nuGenesis are registered trademarks of Waters corporation. t he science of What’s Possible is a trademark of Waters corporation. All other trademarks are the property of their respective owners.
Waters nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.
©2006-2010 Waters corporation. Printed in the u.s.A. september 2010 720001460en lB-AP
Regional Healthcare Laboratory Automates QA/QC Process Workflow with NuGenesis ELN The Client: regional Pharmaceutical QA laboratory, uK national Health service
BACKGROUND
the West midlands regional Pharmaceutical Quality Assurance (QA) laboratory, which is part
of the uK national Health services (nHs), provides pharmaceutical QA/Qc advice to health
care professionals within the region. it is the center for reporting and monitoring of defective
purchased medicines, pharmaceutical specials, and medical devices used in pharmaceutical
manufacturing and administration. the lab provides QA support and assessment to the nHs
supplies central Division Drug contract for purchased medicines used in primary and secondary
care, as well as screening of herbal medicines for illicit active pharmaceutical ingredients.
testing and certification is carried
out in the areas of piped medical gas systems and pharmaceutical clean rooms.
in addition, the lab provides services for audits of unlicensed aseptic manufacturing units as
pharmaceutical QA/Qc services to the university Hospital Birmingham nHs foundation trust.
When a sample arrives in the laboratory, compliance and validation analysts review the
standard operating procedure (soP) documents, and record a notebook entry with reference to
the batch number. Analysts perform the necessary regulatory checks and transfer the sample
to the technicians for analysis, according to the appropriate soP. After all analyses have been
completed and recorded in the notebook, the batch is signed by the validation analyst and the lab
manager who oversees the analyses. the results are then transferred into a trend analysis sheet,
which is presented to the releasing officer for approval. the releasing officer then enters this data
in a lims and determines the fate of the batch.
CHALLENGE
the pharmaceutical QA lab has always operated with a multiple paper notebook system. the
analysts spent a significant amount of time locating the paper notebooks that corresponded
to a particular analysis. this logistics dilemma was exacerbated by an increasing sample load
due to the inclusion of healthcare trusts from an expanded geographic area; the additional influx
of samples was projected to continue into the foreseeable future.
in an effort to address inefficiencies inherent to their paper notebook system, as well as their
increasing workload, the customer sought to implement a structured electronic solution. the
solution would be required to provide an exact 1:1 copy of their current workflow.
NuGenesis ELN reduced the
time spent on data entry,
searching, checking, and
cross-checking information
in manufacturing analysis
by 20%.
49
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
Waters, nuGenesis, and Alliance are registered trademarks of Waters corporation. empower and the science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
nuGenesis eln is covered under a formal Quality management system certified by the tÜV rheinland Group.
Waters nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.
©2007-2010 Waters corporation. Printed in the u.s.A.september 2010 720002050en lB-AP
T HE SOLUT ION
the Waters® nuGenesis® eln is an electronic laboratory notebook that provides customers with the ability to transition from a paper-based to a more automated laboratory process that encompasses the entire scientific content lifecycle, which includes discovery, development, production, and QA/Qc. nuGenesis eln is designed to provide a seamless interface to analytical processing tools and other software programs, such as microsoft excel, Word, or chromatography data software (cDs), such as Waters empower™ software, used everyday in the laboratory. nuGenesis eln allows for the automation of scientific content collection and storage while satisfying compliance requirements, including e-signatures and audit trails.
in this deployment, nuGenesis eln was scaled to process approximately 2,000 analysis orders per year using approximately 600 different substance templates. the initial deployment concentrated on template development, and has been expanded to include regional sample templates, as well as experimental data harvesting.
templates were created in nuGenesis eln for three primary groups of analyzed substances: raw materials, finished products, and ad hoc samples. the laboratory tests approximately 150 different raw materials and approximately 150 finished products; it then assigns an individual template for each product according to soPs and working instructions. the technicians are provided with a fixed identification code and a signed soP document for each raw material. this signed soP is available within the respective raw material analysis templates in nuGenesis eln as a PDf document. excel template objects can be locked, so that only the required fields can be edited.
the QA laboratory also makes use of trend documents for both raw materials and finished products, so that the various substances can be monitored over their entire lifetimes. this trend document is created for each product iD when the soP is created. results from each analysis of of a particular substance over time
are copied from the certificate of Analysis and pasted into the trend document. the trend documents are stored as separate
experiments within nuGenesis eln.
BUSINESS BENEFIT
implementation of nuGenesis eln has allowed the West midlands Pharmaceutical QA laboratory to realize significant gains in analyst productivity. for manufacturing analysis work, time spent searching for information was reduced by approximately one-half day per week per analyst, and the time required for checking, cross-checking, and data entry was reduced by another half day per week; this represents 20% of analyst time that can be allocated to other tasks. for regional lab studies, approximately one day per study per month was also saved.
in addition to productivity gains, nuGenesis eln has contributed to the reduction of calculation errors by automating the conversion to validated data entry templates. nuGenesis eln has also eased the burden of compliance by providing the ability to immediately comply with increased regulatory pressure to track out-of-specification results and associated exception reports.
other nuGenesis eln functionalities of particular utility to the lab include integrated messaging and data viewing. the integrated messaging system, which notifies users of upcoming action items and related record changes, proved very useful for controlling analytical workflow. integrated data viewing has allowed the customer to visualize data (in a single interface) that was produced from an extensive instrument park that includes thermo nicolet ftir, thermo unicam uV, Waters Alliance® HPlc, Agilent
HP1100, finnigan lc/ms, and totalchrom Gc.
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Automation of Doping Control Applications with NuGenesis SDMS And TargetLynx Client: Karolinska University Hospital, Sweden
BACKGROUND
the Doping control lab of the Karolinska university Hospital in stockholm, sweden is one of 33 doping control labs worldwide accredited
by the World Anti-Doping Agency (WADA). the lab’s nine chemists and lab technicians analyze approximately 7,500 samples annually,
including 4,717 athlete samples (compared to 183,337 samples worldwide). 87 positive samples were found at the Karolinska lab in 2006
(3,909 worldwide), using hyphenated chromatographic techniques such as Gc/ms, Gc/nPD, and lc/ms/ms.
Karolinska’s Doping control lab receives samples from a variety of customers, including the swedish sports confederation, WADA,
and other international sports confederations, as well as from correctional institutions and public health services.
the Doping laboratory is primarily financed by payments for analyses performed; therefore the more samples that are run and results
secured, the more income is generated to finance research and extended testing.
CHALLENGE
WADA’s World Anti-Doping code provides an internationally
standardized list of prohibited substances for athletes, both in and
out of competition, as well as specific regulations for particular
sports disciplines. A laboratory’s work is assessed by WADA
on the basis of a “proficiency testing program”, which must be
successfully completed if the laboratory is to retain its status as
an official doping control laboratory.
the Karolinska lab focuses specifically on testing for the 44 diuretics
and other masking agents, as well as the 58 stimulants listed in
the WADA code. in the future, they are planning to add tests for
narcotics and beta-blockers to their spectrum.
tests for diuretics and narcotics have been conducted using
Gc/ms, involving complex sample preparation with hydrolyzation,
extraction, and derivatization. stimulant tests using Gc/nPD
involve similarly complex preparation steps.
increasing regulatory pressure and introduction of new technologies
have driven up the number of samples analyzed and increased the
quality of data produced.
managing information and controlling the flow of data were major
challenges. enhancing the lab’s information and knowledge
management processes is an area where Waters laboratory
informatics has played a crucial role.
T HE SOLUT ION
new analytical methods have been introduced using lc/ms/ms. the
sample preparation for this method is now significantly easier, since
a diluted urine sample can be directly injected into the instrument
with an internal standard added. this allows for more samples to
be prepared and analyzed.
the solution chosen by the Karolinska Doping control lab is
the Waters® AcQuitY uPlc® system with a BeH shield rP18
column, 50 x 2 mm, 1.7 µm, with a flow rate of 0.4 ml/min
(meoH/nH4oAc 10 mm gradient, 6 min). A Qc sample is run at every
12th injection; water and urine are used as blanks. for detection,
Waters’ Quattro Premier™ Xe tandem quadrupole mass spectrometer
is operated in mrm mode. the instruments are controlled by Waters’
masslynx™ software, with processing and reporting done using the
targetlynx™ Application manager. targetlynx is specifically designed
for quantitation and specific analyte confirmation, and it streamlines
and automates the analysis of samples.
All raw instrument data are automatically and securely captured
and stored within Waters’ nuGenesis® scientific Data management
system (sDms).
51
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com
Waters, AcQuitY uPlc, nuGenesis, and uPlc are registered trademarks of Waters corporation. Quattro Premier, masslynx, targetlynx, and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
Waters nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.
©2008-2010 Waters corporation. Printed in the u.s.A.september 2010 720002795en lB-AP
the Karolinska lab has found that with the uPlc® system, they
can now screen up to 105 analytes in 8 minutes, injection to injection.
the hospital uses targetlynx Application manager to find analytes
that comply with three criteria:
■■ correct retention time■■ Above signal-to-noise
■■ Above concentration threshold
if a positive hit of an illegal drug is detected, targetlynx will
flag this analyte.
Having automated the analysis and post analysis calculations,
they were still faced with the need to manually review 140
compounds per sample and determine the positive hit patterns.
today, there are more than 100 samples in each batch. this
manual process is tedious and time consuming, where mistakes
can easily be made. most samples are negative (only 2.5% of
samples are positive).
the next step was to automate and streamline the targetlynx
report utilizing the Print capture capabilities within nuGenesis sDms.
Analysts now print all reports into sDms with a targetlynx format, that
includes the stimulants, ephedrines, and diuretics as individual
reports. these reports are normally several hundred pages long.
When analysts run the custom application provided by the Waters
enterprise software solutions (ess) group, they have the choice of
defining the batch number by parameters that include standards,
controls, and blanks. then all reports can be extracted from a
particular batch, excluding all standards, Qcs, and internal control
analytes. Qc results are automatically exported to their lims.
the end result is an sDms report of analytes that were found,
detailed by batch number and name of compound. Within this
“hit list”, users can click a link and sDms outputs the printed
targetlynx report that is stored within sDms. Analysts can
review the report like they always have, but now they only have to
concentrate on verifying the true positive hits (approximately 187
per year) instead of reviewing all 7,500 reports.
BUSINESS BENEFIT
the Waters solution is providing a number of benefits to the
Karolinska university Hospital’s Doping control laboratory
operations including:
■■ Increased revenue potential – Greater sample throughput
with uPlc/ms/ms.
■■ Greater productivity – Approximately two hours are saved
per batch in reviewing results for illegal compounds with
sDms and targetlynx reports.
■■ Reducing risk of data loss – sDms automatically manages
raw data backups from all lc/ms instruments.
■■ Better data accessibility – All reports and raw data are fully
text searchable from within sDms, reducing the time needed
to locate critical information.
■■ Connecting science to the business of the hospital –
targetlynx and sDms have automated and streamlined
results calculations, review, and consolidated reporting.
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BACKGROUND
the Physical chemistry group at a major pharmaceutical company was created to support
discovery projects in hit identification, lead identification, and lead optimization phases
with early physicochemical data gathering. the Discovery groups send test requests for
selected compounds simultaneously to respective departments via the chemical support (cs)
team within the chemistry department. the chemistry department is where all synthesized
compounds are collected and stored. compounds are sent out for testing according to the
requests, as either standard stock solutions or solid samples.
the Physical chemistry group is made up of three analytical chemists running two lc/uV/ms
systems. each of these systems consist of a Waters® Alliance® Ht system with a 2996
Photodiode Array (PDA) Detector, and a ZQ™ mass Detector, running on masslynx™ software.
testing is done in a 96-well plate format.
Among the analyses performed by the team are identification, purity, stability, and solubility
tests. iD and purity evaluations are always included in all solubility and stability tests and
demand additional processing of data.
CHALLENGE
A screen solubility test of 48 samples took approximately
51 hours of analyst time, from the time that the samples were
received to when the data was entered into the database. for a plate
containing 48 duplicate samples, the variety of tasks involved:
■■ 4 hours doing sample prep and running the samples
■■ 18 hours in the office collecting compound and plate
information – codes, predicted properties, structures,
and creating appropriate sample lists
■■ 8 hours evaluating purity
■■ 19 hours doing the solubility calculations
■■ 2 hours inputting the final data into the company’s database
the analyst would get results over a week later. the Physical
chemistry group recognized that testing results were taking too
long. they needed to significantly reduce bottlenecks in data
management and analysis, as well as instrument resources, to
improve their ability to support discovery projects – especially
since incoming work volume was increasing.
Increasing the Throughput of Physiochemical Profiling with ProfileLynx Application Manager for MassLynx SoftwareThe client: Physical chemistry Group at a major Pharmaceutical company
By implementing
ProfileLynx into
their existing LC/MS
workflow, the chemists
reduced the amount
of time it takes
to perform these
tests from 51 to
just 20 hours.
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Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
T HE SOLUT ION
creating the proper tools for collecting sample information from
the database, formatting sample lists, and analyzing the data
generated consumed a great deal of analyst time.
By implementing Profilelynx™ – a specialized Application manager
for masslynx software that automates processing of physicochemical
property analyses – into their existing lc/ms workflow, chemists
reduced the amount of time it took to perform these tests from 51
to just 20 hours (figure 1). office time was reduced from 17 to 2.5
hours. Because of the improved reporting capabilities of Profilelynx,
the solubility evaluation now takes just 4 hours instead of 19.
BUSINESS BENEFIT
While the lc/ms sample analyses were efficient for the screen
solubility test, processing data and interpreting the results required
tedious and time-consuming data manipulation and calculation. By
introducing Profilelynx and other tools such as masslynx templates
into their workflow, the customer has saved about 30 hours on the
solubility screen for each set of 48 compounds. the time is now used
in the implementation of other tests.
Waters and Alliance are registered trademarks of Waters corporation. masslynx, Profilelynx, ZQ, and t he science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2006-2010 Waters corporation. Printed in the u.s.A.september 2010 720001793en lB-AP
Figure 1. Chemists’ time distribution for a screen solubility test of 48 compounds using a manual process (top) versus ProfileLynx implementation (bottom).
0 10 20 30 40 50 60
2005ProfileLynx
2003ManualProcess
Time (hours)
Lab timeOffice timeEvaluation ID/PurityEvaluation SolubilityDatabase
As a result of the overall time savings, the group is able to
analyze more samples, as well as provide the critical information
necessary to make decisions about possible lead candidates
more quickly.
Because of the success of Profilelynx with this evaluation, the
software will be implemented with other tests within the Physical
chemistry group, including solid solubility, stability, and elogD.
WAT ERS SOLUT IONS FOR LEAD OPT IMIZAT ION
Waters system solutions for lead optimization provide an
automated, efficient selection process for determining compounds
that have potential to become successful therapeutics. these
solutions combine the strengths of Waters instruments,
chemistries, software, and customer support to assist discovery
labs in characterizing
compounds faster, easier, and more cost effectively.
Waters masslynx software and its Profilelynx Application manager
streamline data management for physicochemical property
profiling. masslynx interfaces with upstream data systems to
build sample lists used for data acquisition, while Profilelynx
automates the processing of chromatography-based data for
physicochemical property analysis.
57
BACKGROUND
the chemical surveillance Department (Veterinary sciences Division) of the Agri-food and
Biosciences institute (AfBi), a uK-based organization, tests food of animal origin for residues
of both banned substances and licensed veterinary drugs. the department is staffed by
approximately 60 scientists, who analyze approximately 35,000 samples annually, utilizing a variety
of analytical technologies including lc/ms/ms.
laboratory procedures are regularly audited by regulatory agencies and accreditation bodies
to ensure that the analytical methods are appropriately validated, demonstrating “fitness for
purpose”, and to ensure that the lab is carrying out its duties in accordance with accepted standards
set by the european union (eu). this includes maintaining accurate records, continuity of evidence,
and effective audit trails on all samples that enter the laboratory, including date received, date
tested, test method, and date released. failure to employ acceptable, well-defined and documented
methods or inadequate recordkeeping could result in loss of accreditation certification.
CHALLENGE
eu legislation demands that tandem mass spectrometric confirmatory methods monitor a
minimum of two “daughter” transition ions when confirming the presence of veterinary drug
residues in food of animal origin. recent advances in instrumentation have provided the ability
to monitor ever-larger numbers of transition products in much shorter periods of time.
one such technique employed by AfBi is the Waters® AcQuitY uPlc® system with the
Quattro Premier™ Xe tandem quadrupole mass spectrometer. the AcQuitY uPlc system
combines unique instrumentation and column chemistries to yield dramatically improved
resolution and speed. combined with the Quattro Premier Xe’s fast data acquisition rates and
ability to rapidly switch polarity – monitoring positively and negatively charged compounds in a
duty cycle of about 20 milliseconds – the system can generate more data in a shorter time scale.
laboratories involved in drug residue testing are continually working towards extending the
scope of multi-residue analytical techniques in an effort to reduce turnaround times and
improve cost effectiveness.
With eu regulations necessitating the acquisition, processing, and careful documentation of vast
quantities of data and resultant sample information, the food testing laboratory is faced with a
formidable information management challenge.
High-Throughput Food Safety Lab Automates QA Data Interpretation and Recordkeeping with NuGenesis SDMS And MassLynx Software Client: Agri-Food and Biosciences Institute
Through Waters integrated
Informatics solutions, AFBI
has successfully addressed
regulatory and technological
challenges and significantly
improved workflow and
data management.
58
T HE SOLUT ION
to analyze and manage the large quantities of data produced by
the Waters’ analytical system for food safety, AfBi selected an
integrated informatics solution consisting of Waters masslynx™
software for system control and data acquisition, paired with its
targetlynx™ Application manager, and the Waters nuGenesis®
scientific Data management system (sDms).
targetlynx automates data acquisition, processing, and reporting
for quantitative ms results and it incorporates a range of
confirmatory checks that identify samples that fall outside of
user-specified or regulatory thresholds. Given the sheer volume
of data generated, however, targetlynx reports can become very
large, creating problems associated with archival. With nuGenesis
sDms, both electronic reports and raw data are captured from any
instrument in the laboratory and are automatically stored and
indexed within a searchable database. Data can be easily retrieved
and shared among scientists throughout the organization.
BUSINESS BENEFIT
the Waters solution is providing a number of benefits to AfBi’s
laboratory operations including:
■■ ensuring regulatory compliance through automated targetlynx
calculations demonstrate that the relevant eu legislative criteria
are being fully met. Quantifying a single analytical batch often
requires thousands of calculations and comparisons, which can
all be fully automated using targetlynx.
■■ storing, indexing, and retrieving electronic data from a variety
of analytical instruments produced by multiple vendors. What
would previously have been thousands of pages of hard copy
reports have become fully searchable electronic documents.
■■ easily integrating scientific instruments with office software
and a lims database.
■■ Providing instant access to original experimental raw data
to any scientist connected to sDms, allowing conversion of
data to critical information.
■■ improving productivity through automation of QA data
interpretation and recordkeeping. this removes the need for
manual transcription of quality assurance data, since data
can be automatically extracted from captured reports.
■■ Automating the time-scheduled backup of critical instrumental
data files generated by any vendor’s instrument, or any
electronic file on any Pc.
■■ eliminating the need for generation and archival of thousands
of pages of hard copy reports, and the costs associated with
their production.
the AcQuitY uPlc system, combined with the Quattro Premier
Xe mass spectrometer has improved sample throughput and
is generating better quality data at a faster rate than ever
before. With Waters integrated informatics solutions, AfBi has
successfully addressed regulatory and technological challenges,
and significantly improved workflow and data management of
key information within its analytical food testing laboratory.
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
Waters, AcQuitY uPlc, and nuGenesis are registered trademarks of Waters corporation. Quattro Premier, targetlynx, masslynx, and the science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
©2007-2010 Waters corporation. Printed in the u.s.A.september 2010 720002023en lB-AP
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Analysis Order Turnaround Times Reduced by 25% with Analytical Workflow ManagerClient: A Global Pharmaceutical company
BACKGROUND
A global pharmaceutical company develops drugs to treat a variety of disease conditions
including cancer, heart disease, and HiV. the company’s scientists rely on as many as 30
analytical testing labs that continually analyze thousands of chemical compounds used in or
generated by the drug development process.
structural chemical analysis assists researchers in the discovery of promising new products for
medical and industrial applications, while impurity profiling helps assure the quality of its products.
the research analytical laboratories operate as service centers that accept samples for analysis
from researchers and quality assurance technicians, routing the samples through tests in one or
more labs. the samples are then returned along with the analysis reports to the requesters. this
entire analysis process was paper based.
CHALLENGE
A flexible solution was required to minimize the manual paper-based processes between the research
chemists and the analytical laboratories. this required eliminating the paper-bound chemical analysis
processes at the customer‘s site and developing an efficient online workflow and system for sharing data.
“We wanted to enable the labs to combine their results into a data warehouse so we could provide
value-added research services. And we wanted the researchers to be able to readily benefit from the
analysis data that their colleagues had requested, which would lead to greater collaboration and fewer
duplicate analyses,” said the manager of the nuclear magnetic resonance laboratory.
T HE SOLUT ION
Waters® Analytical Workflow manager (AWm) and a site-wide deployment of the inspector Analytical
Data Viewer were installed to support researchers at the pharmaceutical company’s major site.
Analytical Workflow manager, an analytical laboratory collaborative workflow management
system with its integrated inspector software, met all of the customer’s technical requirements.
AWm was rolled out compliant-ready, helping the client meet the demands of 21 cfr Part 11
and applicable predicate rules where they apply to the documentation of lab workflow and data
procedures through valid digital records and signatures.
the initial rollout served three customer labs. Analytical Workflow manager is currently used
by more than 400 researchers and 40 lab technicians. in this deployment, AWm was scaled to
process up to 20,000 analysis orders per year and store 50,000 result sets.
“ This solution from IBM
and Waters Laboratory
Informatics lays the
foundation for a new era
of discovery based on
researcher empowerment
and global collaboration.”
LAB MANAGER,
GLOBAL PHARMACEUTICAL
COMPANY
62
As the focal point for all analysis performed within its three
participating labs, AWm integrates with several existing systems.
to minimize user training and promote user acceptance, an
interface was developed between the newly deployed systems and
the customer’s virtual electronic laboratory notebook workbench
software. the interface allows researchers to place orders for analysis
and access the results. the AWm receives order requests from the
electronic laboratory notebook workbench software system,
triggering the delivery of requests to the lab technicians.
Waters also integrated AWm with testing equipment in the
labs and with the customer’s classical lims environment. the
lims receives notification of incoming orders, tracks the tests
performed, and routes information to the customer’s sAP system
to efficiently generate billing for each order.
AWm can run on a broad range of servers, from a small intel-
based system to clustered linux, uniX or mainframe platforms.
this scalability and flexibility made the AWm’s Websphere
implementation technically and economically efficient; backed by
iBm support, it was also a low-risk option. the deployment included
iBm systems with Websphere Application server (Advanced
edition), Websphere studio Application Developer (formerly iBm
VisualAge for Java), and servers (iBm rs/6000 sP).
While AWm improves day-to-day productivity in the labs, it also
builds a database of analysis results, running on an iBm rs/6000
sP server. the database, which the customer estimates is growing
by three gigabytes every month, will serve as the basis for
collaboration among researchers.
BUSINESS BENEFIT
turnaround time for analysis orders was reduced by 25% in the
first year after rollout. the system promotes information sharing
and collaboration among researchers across the company. By
integrating analysis reporting with workflow and billing processes,
Analytical Workflow manager helps the customer improve
laboratory productivity while reducing errors.
“this breakthrough is immense. With the expertise of both iBm
and Waters laboratory informatics, we have transformed a dead
resource into a front-line research and workflow tool, while
opening up our analytical lab to the rest of the organization,” said
the lab manager.
the customer plans to implement AWm in five more analytical
labs, and extend the system to research and development
departments in other organizations within the company. the
customer believes that their strong relationship with Waters and
the support from iBm are providing strong impetus to proceed.
“this solution from iBm and Waters laboratory informatics lays
the foundation for a new era of discovery based on researcher
empowerment and global collaboration,” the manager said.
Waters is a registered trademark of Waters corporation. t he science of What’s Possible is a trademark of Waters corporation. All other trademarks are the property of their respective owners.
©2005-2010 Waters corporation. Printed in the u.s.A. september 2010 720001361en lB-AP
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
Waters Corporation 34 maple street milford, mA 01757 u.s.A. t: 1 508 478 2000 f: 1 508 872 1990 www.waters.com
Waters, AcQuitY uPlc, uPc,2 uPlc, symmetry, Atlantis, Xterra, empower, Alliance, AcQuitY, and nuGenesis are registered trademarks of Waters corporation. Q-Dis/Qm, masslynx, Quattro Premier, targetlynx, Profilelynx, ZQ, openlynx, XBridge, and the science of What’s Possible are trademarks of Waters corporation. All other trademarks are the property of their respective owners.
nuGenesis sDms is covered under a formal Quality management system certified by lloyd’s register Quality Assurance.
nuGenesis eln and Analytical Workflow manager are covered under a formal Quality management system certified by the tÜV rheinland Group.
©2012-2013 Waters corporation. Produced in the u.s.A.may 2013 720002493en lB-PDf