Electronic Batch Record Systems
Vinay Goyal
Bita Miskopey
Vanessa MontañezMaral Poladian
Carolyn Salib
November 26, 2012
Outline Introduction Current Situation / Business problem Business Strategy: Electronic Batch Record (EBR) System Regulatory Requirements Capital Budgeting and ROI Effective Business Process Selection Criteria Competitive Advantage Request For Proposal Overall Arching Benefits: Pros and Cons and Ethical
Aspects of Implementing EBR
Project Proposal
Implementation of electronic and automated batch record system within Siemens Healthcare Diagnostics
Who is Siemens Healthcare?
Company Background
Siemens AG: Fortune Global 500 Over 450,000 employees globally 65,000 employees in US: in all 50 states € 73.5 billion global sales Siemens Healthcare:
Over 900 laboratory diagnostic tests
Healthcare is shifting in focus from treatment to prevention, mostly as a result of emergence of biotechnology
There are more than 400 biotech drug products and vaccines currently in trial targeting more than 200 diseases including some cancers
Biotechnology is responsible for hundreds of medical diagnostic test that keep the blood supply safe from HIV
Biotech industry has mushroomed since 1992 US healthcare revenues (from publicly traded companies) rising
from $8 billion in 1992 to $59 billion in 2009
Biotech processes has dramatically improved criminal investigation and forensic medicine
Biotechnology Industry: general facts
What is a batch record?One big recipe!
Components of a BR – to name a few… Product Name Company Name Date of Manufacture Expiration Date Storage Conditions Materials/Ingredients/Equipment Used Step-by-Step Processing and Testing Signatures Required
They accompany the batch of a product throughout all phases of manufacturing
Background and Introduction Evolution of technology and automation has changed the
way we do business today
Yet, most biotech, drug manufacturing and pharmaceutical companies do not use paperless systems
Movement toward electronic systems is slow
One of the main reasons is that it is extremely difficult and risky to be in compliance with CFR Part 11
Organizations don’t want to risk regulatory liability exposure
Why Regulate? Significant events have shaped the
regulation of biotechnology and pharmaceutical industries by the Federal Food and Drug Administration (FDA) 1912-Mrs. Winslow’s Soothing Syrup
for teething babies, laced with morphine killed many infants
1962-Thalidomide, a new sleeping pill, was found to have caused birth defects in thousands of babies born in Western Europe
Why do Regulations Exist To protect the public health and safety!
It’s no more complicated than that!
Some Regulatory Agencies
Federal Food and Drug Administration ISO 13485 Good Manufacturing Practices-cGMP (Guidance) European Directive 98/79/EC German Act Canadian Regulations SOR/98-282 Japanese Ordinance Act
What is 21 CFR Part 11
Federal regulation that describes how a FDA regulated industry creates, maintains, retrieves, modifies, and archives electronic records
Establishes criteria for the use of electronic records and electronic signatures to comply with predicate rules on records.
What is cGMP
Current Good Manufacturing Processes
Enforced by U.S. Food and Drug Administration
Lack of cGMP compliance may result in a number of regulatory actions taken against the organization
Business Situation/ProblemSiemens Healthcare Produces Paper and Diagnostic Tests
Analysis of Current Situation Study current processes and workflow
Review any deviations in the process
Review cycle time
Review internal and external audit reports
Study cost of operation
Study the visibility of the supply chain, inventory, and availability of equipment
Business Situation/Problem
Batch operations are conducted manually Time consuming. Too much paper to handle Every step has to be signed and dated by the operator In many cases by a supervisor too
Inefficient Inherently slow, cumbersome and error-prone
Poor Tracking A serious problem in case you need to identify defects Physical tracking of logs, records, test results
Business Strategy: EBR Implementing Electronic Batch Record (EBR) System
Electronic Batch Record It provides for
Complete history of a production batch Identifies all materials and data Operator interactions Electronic signatures Quality due-diligence information
Collection of information required for reporting to Quality Assurance Food and Drug Administration Customers
Business Strategy: EBR Implementing Electronic Batch Record (EBR) System
Put together Work instructions Formulations Processing information List of ingredients Applicable specifications Measuring and test equipment information Records Compliance and regulatory requirements
Competitive Advantage
Siemens currently is using written batches and formulas
Electronic Batch Records will provide a competitive advantage
Save labor and time Create consistency and accountability Able to track and measure
EBR Vendor Comparisons
Type a brief overview or summary of
your project here.
Batch Master InstantGMP Mar-Kov CMS NeoDyne Master Control SYNCAD
Sytem Client/Server Web Client/Server Client/Server Client/Server Client/Server
Inventory Control yes yes yes no no yes
Purchasing no yes yes no no no
Equipment Log no yes yes no no no
Part 11 Compliant no yes yes no yes no
Audit Log no yes yes yes no no
Totals yes 1 5 5 1 1 1
Vendor Criteria
1. Research reputation of the vendor2. How frequently does the vendor update technology3. What types of continued support are provided4. Other Categories outlined on table
Best Vendor Criteria
5. Instant GMP6. MAR-Kov CMS
Request For Proposal (RFP) Industry Summary
Siemen’s “Agenda 2013” - New 2 year global initiative aimed Improving Sector’s competitive position Expanding its capacity for innovation Higher expenses in R&D and SG&A YTD revenue for Healthcare increased 8% compared prior year
EBR Overview Use of EBR systems is more prevalent in the Healthcare
Industry Streamline manufacturing processes Improving regulatory compliance System efficiencies Cost savings
Approach
Facilitates best practices in production and
manufacturing
Increase accuracy in logs, inventory, bill of materials
Optimizes resource utilization
Decrease overhead
Reduce product variation and defects
Increase margins and cash flow
Results
Best Vendors based on our analysis GMP and MAR-Kov CMS IT adoption process will enable Siemens to substitute paper
based system with automated electronic manufacturing process
Increase compliance with regulatory agencies System would present an intuitive, navigable and easy to
learn interface with its users System flexible and configurable process with improved
product quality and safety. Quality checks and built in security
SWOT of EBR
Strengths• Dedicated workforce• Previous success with other
implementations ( SAP)• Management commitment • Training
Weakness Older generation workforce
reluctant to change Disruption during transition Not enough workforce to
transfer manual procedures into EBR system
SWOT of EBR
Opportunity Improve FD compliance Efficient and quicker data Improve information
sharing More opportunities for
employment
Threats Demand for hiring trainers
can be rejected by management
Can surpass budget – costs Workforce can be reduced
as EBR becomes efficient Workforce disruption can
cause customer complaints and loss
BenefitsSince the adoption of computers we have been able to simplify our lives and make our work easier and more accurate: Benefits of Electronic Batch Records Include:
• The EBR system increases the speed of production because electronic batch records are easy to update, transfer, and review.
• Efficient retrieval of information: with information in a digital format it is fast and easy to retrieve information saving time and manpower.
• Increased productivity- with EBR less time will be spent collecting the various components of the batch record from different departments.
Benefits Cost avoidance- batch records must be retained for at least
two years after the expiration of the product. However, use of EBR can eliminate the need to allocate resources to the storage
• Increased speed of product changes and product introductions- use of EBR in the development process will lead to greater efficiencies in new drug implementation and applications
• Better documentation- Doctors are legendary for illegible hand writing leading to inaccurate data entry by a second or third party.
Change Management and Affected Business Process
Implementation has a huge impact on employee behavior and organization
Resistance from employees may hinder the success of an adequate system implementation
Need to identify and address potential employee concerns
Systems analyst: acts a leader throughout the process
Employee Participation
High level of management support Employee participation: opinions are heard and taken into
consideration - afterall, employees will use system Advantage:
Improved employee morale Changes are not a surprise
Lack of participation: Gap between end users and IT specialist Employees are not excited about transition and are
not on board
Capital Budgeting
Review cash inflow and outflow of the project Investment costs: hardware, software and labor Cash inflow: increased sales of new products and
improved quality Cash outflow: cost of new software & training Cost savings: reduced costs and employees can
allocate their time towards different projects (Agenda 2013)
Return on Investment
Used to determine whether or not to move forward with the project
Cost of Software: $40k to $1 million or 54k to $1.35 million Euro
Cost savings: reduced cycle times, improved accuracy and consistency of the batch records, reduced cost of compliance, increased productivity, increased speed of new products to the market, and increased customer satisfaction
Return on Investment
Factors included in ROI Cost of EBR software Increased payroll expense or cost of training Potential gain from implementation
New projects Improved efficiencies
ROI = Gain from investment – CostCost
or 5.8 million – 2.3 million = 1.5 2.3 million
Successful Implementation Keys for successful implementation Phase I
Pre-Assessment Review Readiness and Scope Time: 3 to 5 days
Phase II Documentation Guidelines for Batch Records Change Control and Implementation Pilot Testing Time: 12 to 18 weeks
Phase III Harmonization of Supporting Documents and Processes Change Control and Implementation Pilot Testing Time: 12 to 26 weeks
Phase IV Go Live
Thank You!
That wasn’t bad wasn’t it?
Works Cited US Food and Drug Administration: 21 CFR Part 11 US Food and Drug Administration: 21 CFR Part 820 www.siemens.com/answers Allen, Paul B. Electronic Batch Record Management in the
Pharmaceutical Industry. 25 March 2003 Electronic Batch Record: Who Says You Have To Live With Shrinking
Margins.12 Jan. 2004 Laudon, Kenneth and Lauden, Jane: Management Information
Systems. 2012.