Proactive GCP Compliance
5TH
Risk-Based Approaches to Clinical Quality Management that Support the Principles of GCP, Quality Data, Cost Containment and Patient Safety
EXECUTIVE SUMMARY
Group: Proactive GCP Compliance
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CONTENTS
INTRODUCTION: THE 5TH PROACTIVE GCP COMPLIANCE CONFERENCE 3
2014 SESSION SUMMARIES 4
RESOURCES FOR INFORMATION AND DISCUSSION 11
RECOMMENDED SERVICE PROVIDERS 12
3
INTRODUCTION: 5TH PROACTIVE GCP COMPLIANCE CONFERENCE
If you weren’t able to join us this year, here is what you missed at ExL Pharma’s
5th Proactive GCP Compliance Conference …
Focusing on risk-based approaches to quality management, ExL’s Proactive GCP
Compliance Conference has become the industry’s annual forum for senior-level
clinical quality and operations executives to learn, gather and discuss strategies to
achieve and maintain GCP compliance. Taking place April 2-4, 2014 in Washington
DC, the 5th annual event once again attracted a room full of clinical decision
makers highly engaged in sharing their own best practices and lessons learned as
well as brainstorming on new and innovating approaches, resulting in a meaningful
exchange of ideas and experiences.
This event brought together professionals from pharmaceutical, biotechnology
and medical device companies as well as CROs and other clinical trial service
and technology providers, who work in clinical quality and compliance, clinical
operations and management, quality systems development, monitoring, audits,
inspections and more.
Through the use of an audience response system, speakers were able to poll
the audience, which provided valuable insight into the industry’s perceptions,
understanding and progress as they related to the topics discussed. These topics
included strategies for proactive quality management, identifying risk indicators,
risk-based monitoring approaches, education and training, inspection preparation
and execution, and more.
Following are session summaries and highlights to give you an idea of the
information presented and topics discussed at the 5th Proactive GCP Compliance
Summit.
COMPANY TYPE
60% - Pharma, Biotech Device
11% - CROs
23% - Clinical Service/Tech Providers (non-CROs)
6% - Sites
60%
11%
23%
6%
2014 Audience Breakdown DEPARTMENT
48%
23%
10%
19% 48% - Quality/Compliance
23% -Clinical Operations/Management
10% - Audits/Inspections
19% - Other (C-Level, BD, Consultant, etc.)
OF THE AUDIENCE REPRESENTED DIRECTOR-LEVEL AND ABOVE 65%
4
Returning for her second time as conference Chair,
Jane Wood, Vice President of R&D Quality &
Compliance at Johnson & Johnson, emphasized
that we as an industry are on the journey towards
proactive quality risk management, and asked the
audience their thoughts of this journey, to which
61% responded they are somewhat excited at the
prospect, but still unclear what it means and how to
make it happen. When asked what will most help
on this journey, 55% indicated industry groups
working together and 41% selected ideas that can
be converted into tools that best fit each company.
In looking forward, Jane noted the focus should be
on on increased patient safety, reduced quality and
compliance risks, cost/time savings through
standardized best industry practices and
standardized efforts at clinical research sites and
vendors, best practice sharing, data transparency,
speaking a common language, and proactive,
aggregated data – big data.
Where are you on the journey? As you think about your journey towards
Quality Risk Management (QRM), are you…
April 2014 J. Wood 4 1 2 3 4
2% 2%
35%
61%1. Despondent, nothing has really changed
2. Somewhat excited at the prospect but sKll unclear what it means/how to make it happen
3. Fully onboard and in implementaKon
4. Boring! What’s next?
What will most help you on the journey?
April 2014 J. Wood 8 1 2 3 4
4%0%
41%
55%
1. New regulaKons and/or advice from the Regulators?
2. Industry groups working together to achieve the same aim?
3. Just give me ideas that I can convert into tools that suit my company
4. Leave me alone?!
During the opening session, Rich Azueta, Regional
Head of GCP/GMP Audits in The Americas for
Novartis spoke about Understanding the Global
Drivers behind the Industry’s Move toward
Risk-based Approaches and What it Means for
Clinical Research. He indicated, when it comes
to risk management the drivers are productivity
(cost, complexity of studies, reactive approach),
inspection and audit findings, advances in
technology, going green and guidance. When
asked, 62 percent of audience members noted
that their company takes a risk-based approach
to conducting clinical trials, but 47% indicated
their company lacks training on risk management
principles and tools.
ARS Question Does your company take a risk-based approach in conducting clinical trials?
| 5th Proactive GCP Compliance | Richard Azueta | April 3, 2014 | Risk Based Clinical Research | Public 21
1 2 3
62%
16%22%
1. Yes 2. No 3. I Don’t Know
ARS Question Does your company have training on risk management principles and tools?
| 5th Proactive GCP Compliance | Richard Azueta | April 3, 2014 | Risk Based Clinical Research | Public 12
1 2 3
35%
18%
47%1. Yes 2. No 3. I Don’t Know
SESSION SUMMARIES
5
The panel that followed on Risk Indicators, was
moderated by Sam Sather of Clinical Pathways
and comprised of Rich Azueta of Novartis, Fred
Feldstein of Pfizer, Kirsten Morasco of Compliance
Implementation Services (CIS) and Linda Sullivan
of the Metrics Champion Consortium. 64% of
the audience indicated that they are currently
measuring specific risk indicators for clinical trials,
and the expert panel then shared specific examples
of effective risk indicators. When discussing
strategies for reporting risk indicators, 56%
indicated they do this geographically, versus 27%
numerically and 17% other.
5th Proactive GCP Compliance – April 2-4, 2014, Washington DC www.exlpharma.com/GCP
Specific Risk Indicators being used to uncover current and potential problem areas
1 2
36%
64%
1. Yes 2. No
ARS Question Do you measure specific risk indicators for clinical trials?
5th Proactive GCP Compliance – April 2-4, 2014, Washington DC www.exlpharma.com/GCP
Specific Risk Indicators being used to uncover current and potential problem areas
1 2 3
27%
17%
56%
1. Numerically 2. Graphically (traffic
light) 3. Other
ARS Question How do you report risk indicators?
The next several sessions focused on Risk-Based Monitoring, starting with a presentation by Teresa Lamantia, Vice President of Operations and Global Clinical Site Monitoring at Quintiles, who engaged the audience with a presentation on Defining the Risk-Based Monitoring Approach and Outlining the Critical Elements for Effective Execution. Teresa indicated recent market research shows that risk-based monitoring (RBM) has a high level of awareness among key decision-makers in the biopharma industry – up to nearly 80 percent from 65 percent a year ago, with half currently implementing some RBM aspect. Of the non-RBM users, 60% are planning to implement RBM in a clinical trial over the next two years and 81% over the next three years. She outlined the ideal RBM approach as a fully integrated solution that brings together data across clinical development to optimize and improve clinical trial delivery by leveraging risk assessment, ongoing data surveillance and dynamic monitoring. The benefits to sponsors include integrated data for holistic trial insights, improved data quality and patient safety, identification and mitigation of risks and lower costs. The new monitoring model is automated, proactive, centralized, integrated and decisions are driven by data. Resources are focused, based on risk and there exists a balanced relationship between on-site and centralized monitoring that can improve delivery and quality, leading to better trial performance.
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Traditional Model New Model
Manual
Reactive
Onsite
Siloed
Subjective Management
Centralized
Proactive
Automated
Data-Driven Decision
Integrated
A New Clinical Trial Monitoring Model
7
Data-driven Trial Execution
Data surveillance allows for optimization of and adapted monitoring throughout the trial, re-assessing risk and applying the right action at the right time.
Use the right type of monitoring at the right time (on-site, remote, centralized), monitoring sites, data, patients and events that require more attention and focus.
Regulatory bodies agree to begin with an in-depth risk assessment where our team of experts evaluates the scientific and operational risk of each protocol.
“It was great to hear from a variety of perspectives how to effectively identify and manage risk. We covered the importance of choosing risk indicators to uncover current and potential problem areas and determining strategies for establishing appropriate indicator tolerance levels, and shared best practices for conducting risk assessments and reassessments. This panel was just one of many educational sessions that provided clinical professionals with the knowledge and tools to optimize clinical quality and compliance.” -Kirsten Morasco, Compliance Implementation Services (CIS)
6
Mark Travers, Vice President and Head of Clinical
Study Units at Sanofi came to the stage next with
an entertaining talk on RBM Implementation, titled
Implementing Effective Risk-Based Monitoring
that Ensures Clinical Quality, Compliance and
Patient Safety. After learning that 72% of audience
members are currently implementing an RBM
approach within their organizations, Mark went on
to define RBM as an adaptive approach to clinical
trial monitoring that directs monitoring focus and
activities to the evolving areas of greatest need
which have the most potential to impact patient
safety and data quality. Mark then described the
core elements of the TransCelerate RBM Process
and the importance of effective risk assessment.
communication strategies and what to do when
the sponsor and CRO differ on their assignment of
cause.
Q1: Are you currently implementing an RBM approach within your organization?
Sanofi US | 4
1 2 3
72%
6%
23%
1. Yes 2. No 3. Unknown
TransCelerate RBM Process
Risk Assessments
•Complete Risk Assessment Categorization Template (RACT)
Critical Data Points
•Define at the Program Level
•Reassess at the Protocol Level
Risk Plan
•Develop Integrated Quality and Risk Management Plan (IQRMP)
Monitoring Plan (MP)
•Define Risk Indicators
•Define On-‐site, Off-‐site, and Central Monitoring Activities
Monitoring Execution
•Execute Monitoring Activities
RACT IQRMP
Risk-‐Based Monitoring (RBM)
On-‐Site Monitoring Activities
Quality by Design (QbD) Bubble = Tools
Companion Guide
Risk Indicators
The RBM portion of the event as well as the first
main conference day, concluded with an expert
panel on Identifying the Challenges, Overcoming
the Obstacles and Sharing Best Practices for
Effective Execution of Risk-Based Monitoring.
Liz Wool of QD-Quality and Training Solutions
moderated the panel, which included Teresa
Lamantia of Quntiles, Kathrin Laubacher of
Hoffman La-Roche AG, Shankar Srinivasan of the
Mayo Clinic and Pamela Strobel of Inventiv Health
Clinical. This diverse panel offered the varying
perspectives of trial sponsors, CROs as well as sites
on topics such as how the monitoring model is
changing, actions that have been taken to enable
effective RBM, challenges and obstacles associated
with risk-based monitoring, how regulatory
agencies view RBM, strategies for measuring
RBM’s effectiveness and modified staff training
requirements.
During her day two opening remarks, conference
Chair, Jane Wood, urged that “we must move the
needle of compliance together,” offering a road
map for the day and journey ahead. The final
day opened with an inspiring keynote case study
detailing Pfizer’s journey towards proactive quality
management, presented by Coleen Glessner, Vice
President, Clinical Trial Process Quality at Pfizer,
specifically focusing on Identifying and Leveraging
Processes, Standards and Quality Behaviors for
Proactive Quality Management and Effective
Oversight. She shared the elements of Pfizer’s
Quality Framework, which include quality planning,
quality control and quality improvement. She
discussed their Integrated Quality Management
Plan, which is an end to end process directed at
quality in clinical trials whereby proactive quality
planning drives quality control, which drives quality
improvement. She accentuated the importance
of leadership vision and behaviors as well as
accountability in instituting cultural change, and
outlined what’s been accomplished to date on their
path to seamless, enabled quality.
The Quality Framework: Our Path to Sustainable Quality
QUALITY PLANNING
Understand What Ma'ers Most for every trial and every clinical process
Quality Management Framework
QUALITY CONTROL
Mechanisms in place to Monitor, Manage and Control What Ma'ers Most
QUALITY IMPROVEMENT
Quickly iden8fy areas to improve What Ma'ers Most
Quality Planning
Quality Control
Quality Improvement
5
7
Our GCP Quality Culture Building Blocks
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Next we had a lively discussion on Global
Inspection Preparation and Management, led by
Paul Strickland of Strickland Quality Assurance
with Ellen Leidel-Sargent of Icon, Lisa Murphy
of Biogen Idec, Steven Talerico of Merck and
Ann Varker of Boehringer Ingelheim making up
the expert panel. The discussion started with an
assessment of the audience’s inspection experience,
asking first “Have you personally been involved
with GCP inspections at the sponsor?” with 42%
indicating that they’ve had lead roles, followed by
34% indicating they have had supporting roles.
The next question asked the same thing but with
inspections at the site level with 39% indicating
they have had lead roles and 28% with supporting
roles. The panelists then each went into detail about
their own inspection experience, focusing on the
key differences between FDA, EMA and MHRA
inspections.
5th Proactive GCP Compliance – April 2-4, 2014, Washington DC www.exlpharma.com/GCP
Have you personally been involved with GCP inspections at the sponsor?
1 2 3 4
16%
42%
34%
8%
1. Not yet 2. Company has but not
me personally 3. I have had supporting
roles 4. I have had lead roles
5th Proactive GCP Compliance – April 2-4, 2014, Washington DC www.exlpharma.com/GCP
Have you personally been involved with GCP inspections at a clinical investigator site?
1 2 3 4
22%
39%
28%
11%
1. Not yet 2. Company has but not
me personally 3. I have had supporting
roles 4. I have had lead roles
At this point in the conference, the audience splits
and has the choice of two tracks of sessions. Track
A started with a presentation by Joe Goodman,
Director of Solutions Consulting at Sparta Systems,
on Enterprise Risk Management: Evaluating and
Assessing Internal Processes to Develop an
Effective Corporate Business Strategy to Manage
and Mitigate Risk. It was discovered that nearly half
of the audience was not presently using risk
management software. Joe then went on to define
risk management as the new benchmark for
continuous improvement and an integral part of a
comprehensive enterprise quality management
system (EQMS). He then goes on to describe steps
for developing an internal risk strategy, conducting
risk assessment, risk implementation, and the role of
risk analytics all as valuable elements of holistic
quality management.
Polling Ques3on
3 1 2 3
39%
13%
48%
1. Yes 2. No 3. Don’t know
Are you currently using Risk Management or EQMS so7ware (not Excel)?
8
Show the value
35
§ HolisGc quality management including Risk Management
• Enables early detecGon of potenGal quality & compliance issues • EliminaGon of point soluGons for Risk Management • Enables risk prioriGzaGon & focused allocaGon of costs & resources • Analyzing quality data with risk calculaGons will occur in one system and be seamless
• A formal program will enable companies to adhere to Risk Management regulaGons and guidelines
• ResulGng from CAPA processes, fact-‐based risk assessment supports coordinated transfer of knowledge from one area to other impacted areas
• A formal program will offer Risk Tools like 5 Why’s, Fishbone Diagram, ALARP, RPN, CalculaGons, etc…….
Track A then continues with a case study on
Streamlining Internal Operations presented by Jodi
Campbell Meck, Director, Global Clinical Quality
Management and Fran DeGennaro-Culver, Director,
Clinical Research, Global Clinical Quality
Management both from Merck. A full 80% of
audience members said that their organizations are
more reactive than proactive with regard to quality
and compliance. Of those in the audience whose
organizations have a Quality Management Model,
45% indicated the model is 0-3 years old, with 15%
indicating they do not have one. Fran and Jodi then
went on to describe the operational structure of
Merck’s New Proactive Clinical Quality Management
Model that aims to implement quality risk
management early in the life cycle of a study, using
risk assessments at multiple points in time - from
protocol development through database lock - with
an eye to eliminating or minimizing risks to safety of
subject and data integrity.
Polling Question
9
1 2 3
80%
0%
20%
1. Reactive 2. Proactive 3. Don’t Know
With regard to quality and compliance in your organization, would you say your company is more REACTIVE than PROACTIVE?
[Reactive that changes are made quickly without process to detect/analyze/remediate/prevent and Proactive that changes
follow a process to detect/analyze/remediate/prevent]
Polling Question
14
1 2 3 4 5
5%
40%
15%
20%20%
1. Less than 1 year in development
2. 1 – 3 years 3. 4 – 7 years 4. 8 + years 5. Do not have QMM
If your company has as a Quality Management Model, is it:
The Quality Management Model (New model)
17
Concurrently, the first session of Track B featured a
case study on risk-based management planning and
execution focused on “Developing and Executing
a Comprehensive Risk-Based Management Plan
Using Targeted SDV and Evaluating the Results”
presented by Maryann Livolsi, Director of R&D
Quality Assurance & Compliance and Brooke
Geibel, Associate Clinical Program Director,
Clinical Development Operations and Biometrics
both from Shire. Through effective risk evaluation
of the study a plan was developed that executed
targeted data review as well as SDV, which
generated metrics used to track the ongoing
performance of the trial. Evaluating these metrics
resulted in adjusted monitoring efforts and effective
issue management. Lessons learned included that
risks are not static, so an effective plan needs to be
dynamic, utilize metrics, trends and audit findings
to highlight areas that require additional oversight
during a trial and individually identified issues may
provide insight into larger program concerns.
9
To be as brave as the people we help
16
Evaluation / Impact
• Targeted Data Review • Overall 50% reduction of volume in in-house data review • Did not significantly reduce time spent on data review • Allowed team opportunity to spend more time on key conduct
and patient safety endpoints
• Targeted SDV • Contributed to management of SDV backlog • Impact lessened by mid-program introduction • Addressed in Monitoring Plan and Separate Targeted SDV plan • Included tools for documenting less than 100% review • Not readily adopted by monitoring team (implemented at 33% of
sites) • Systems were not configured for less than 100% SDV
The next presentation during Track B included
another joint presentation, case study, this one on
Developing a Function-based Quality Management
System for Effective Vendor Oversight which was
presented by Mary Ellis, Senior Quality Associate,
Data Management and Danielle Horton, Data
Management Vendor Manager both of Biogen
Idec. Providing a functional area perspective, the
case study discussed identifying gaps in current
processes, the critical components of a vendor
oversight quality management system (QMS), the
objectives of their QMS, current implementation
status and how roadblocks were overcome. 75% of
attendees said that their companies had functional
expertise included in their vendor qualification
process, and 67% said they had a vendor oversight
process at the functional level.
Polling Question Do you have functional expertise included in your Vendor Qualification process?
12 1 2 3
75%
0%
25%
1. Yes 2. No 3. Don’t Know
Polling Question Do you have a Vendor Oversight process at the functional level?
13 1 2 3
67%
11%
22%
1. Yes 2. No 3. Don’t know
Goals of Functional Area Vendor QMS: Long Term!
29!
!
! !.!
!
!
Mitigate Risk!
Share Information!
Improve Quality!
The audience then came back together for a
general session on GCP Education and Training
presented by Kathrin Laubacher, Vice Director and
Team Leader Training in Clinical QA at Hoffman
La-Roche AG in Switzerland. Kathrin provided
an overview of the drivers behind the changing
training needs and discussed regulatory authority
requirements. She elaborated on the 6Ds when
designing quality training: define, design, deliver,
drive, deploy and document. She highlighted the
Practical Training Value Measurement Model to
assess the effectiveness of the training and outlined
how training can be used as a tool for proactively
identifying and mitigating risks.
Practical Training Value Measurement Model
Training Expectation Measurement Tool: Survey Form
Training effectiveness Measurement Tool: Quarterly Follow-on Survey from Managers
Student feedback
Expectations
Post-Training On-Job Behavior
Survey
Effectiveness
Improvement in business indicators, revenue figures
or success parameters
Impact
Pre-Training Vs Post-Training
Assessment
Improvement Training Improvement Measurement Tool: Pre-training and Post-training Survey Forms. Post-training performance tests.
Training Impact Measurement Tool: Comparison of Baseline data and Quarterly business data, Impact Factor calculation sheets
16 5th Proactive GCP Compliance
10
Training as a tool for Proactively identifying and mitigating Risks Four key questions to discuss :
1. What business needs will be met by the training? 2. What will participants do better and differently as a result? 3. What or who will be able to confirm these changes? 4. What are the specific criteria for success?
Audit and inspection findings give a good overview where the training needs to be improved
21 5th Proactive GCP Compliance
The conference then concluded with a dynamic panel
on Proactive Compliance Models: Performing and
Learning from Trending Analysis to Prevent Non-
Compliance through Effective Proactive Approaches
moderated by Lynn Van Dermark, CEO, Medtrials with
panelists Sara Brannon, Associate Director, Training
& Quality Control at RPS, Maryann Livolsi, Director
of R&D Quality Assurance & Compliance at Shire and
Doreen McGirl, Associate Director, Clinical Quality
Management at Otsuka. Nearly 60% of organizations
present said that they conduct formal trending analysis
to prevent non-compliance, while quarterly reports
of frequency of incidence of selected risk indicators
over a rolling 12-month period was identified as being
the most useful from audit findings. The discussion
then focused on strategies for using audit findings to
identify and collect the appropriate information on
current processes and former non-compliances, the
types of analysis that can be used to identify areas
of current/potential non-compliance, and examples
of learning to improve processes and ensure ongoing
compliance.
5th Proactive GCP Compliance – April 2-4, 2014, Washington DC www.exlpharma.com/GCP
Polling Question Does your organization conduct formal trending
analysis to prevent non-compliance?
1 2 3
59%
6%
34%
1. Yes 2. No 3. Don’t know
5th Proactive GCP Compliance – April 2-4, 2014, Washington DC www.exlpharma.com/GCP
Polling Question Which of the following information would be most useful
as identified from audit findings?
1 2 3 4
4%
58%
33%
4%
1. Monthly reports of frequency and incidence of selected risk indicators
2. Quarterly reports of frequency and incidence of selected risk indicators
3. Monthly reports of frequency and incidence of selected risk indicators over rolling 12-month period
4. Quarterly reports of frequency of incidence of selected risk indicators over rolling 12-month period
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RESOURCES FOR INFORMATION AND DISCUSSION
PROACTIVE GCP COMPLIANCE ONLINE DISCUSSION GROUP
Discuss the topics addressed during this conference as well as other GCP-related subjects by becoming
a member of the Proactive GCP Compliance LinkedIn® Discussion Group. With well over 2500 members,
this active group offers a valuable forum for learning from and engaging with like-minded professionals all
focused on optimizing clinical quality management and improving clinical performance. Use this forum to
ask questions, share best practices, link to relevant articles and white papers and learn from one another.
Click here and request to join.
UPCOMING EVENTS
6TH PROACTIVE GCP COMPLIANCE CONFERENCE Effective Risk-Based Approaches for Optimizing Clinical Quality March 24-25, 2015, Wyndham Philadelphia Historic District, Philadelphia, PA www.exlevents.com/GCP
For more information on these and other upcoming events, please contact
Kristen Hunter at 212-400-6241 or [email protected]
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RECOMMENDED SERVICE PROVIDERS
CLINAUDITS ClinAudits is a truly independent organization providing auditing and compliance consulting services domestically and throughout the world. Continuing for over 20 years, clients receive customized services requiring expertise and direct experience with GCP, GTP, GMP, GLP, REMs, tobacco, and animal health. All activities are coordinated centrally from our offices in northern New Jersey. Regionally-based, senior-level auditors conduct on-site or remote audits and other compliance services relating to pre-clinical research through Phase 4 development programs, and onto commercialization of products. Be it a need to address a single, immediate QA event or to serve the complete QA function, ClinAudits’ approach is to clarify the specific need and then develop and implement an effective plan…all while delivering exceptional quality, service, and value. http://www.clinaudits.com
COMPLIANCE IMPLEMENTATION SERVICES (CIS) Compliance Implementation Services (CIS) is a consulting firm focused on helping life sciences clients proactively manage complex compliance requirements. We offer a broad portfolio of services and solutions that expand deep into the clinical, manufacturing and commercial disciplines and that align with our clients’ strategic priorities and business operations. CIS continually provides leadership, global regulatory knowledge, industry experience and a problem-solving culture that responds to today’s compliance and commercial challenges. http://www.cis-partners.com/
QUINTILES INC Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 28,000 employees conducting business in approximately 100 countries. We have helped develop or commercialize all of the top-50 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment. http://www.quintiles.com
QUMAS QUMAS is the leader in Compliance and Quality Management Solutions for the Life Sciences industry, with more than 260 global customer deployments and domain expertise in regulatory compliance since 1994.
QUMAS Quality Management solutions provide Electronic Document Management (SOPs, QA documents), Electronic Process Management (CAPA, Deviation, Change Control, Audit), and GMP Compliance Management. QUMAS Regulatory Affairs solutions provide content and Submission Management including eCTD authoring templates, collaborative review, full integration with leading publishing solutions, scanning, and automated import of paper documents.
The QUMAS Compliance Platform is available on Microsoft SharePoint 2010, Oracle, EMC Documentum and Microsoft SQL Server. http://www.qumas.com
C O M P L I A N C E
IMPLEMENTATION SERVICES
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RECOMMENDED SERVICE PROVIDERS
SPARTA SYSTEMS Sparta Systems Inc. quality management solutions enable organizations to safely and efficiently deliver products and services to market. Its TrackWise® Enterprise Quality Management Software, trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the enterprise. http://www.spartasystems.com
ZIGZAG ASSOCIATES Zigzag Associates Ltd is a Global Quality Assurance (`QA’) consultancy company based in the UK, who can provide a team of highly experienced QA professionals to support you. Whether you need ad hoc support, a more regular commitment through outsourcing, or an experienced team to partner with on audit programs, we can offer you a flexible, pragmatic and responsive global service tailored to suit your requirements. We specialise in audits, inspection readiness, Quality Management Systems and training. http://www.zigzag.eu.com
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