Electronic Batch Record Systems

1. Electronic Batch Record Systems Vinay Goyal Bita Miskopey Vanessa Montañez Maral Poladian Carolyn Salib November 26, 2012

2. 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 Outline

3. Project Proposal Implementation of electronic and automated batch record system within Siemens Healthcare Diagnostics

4. Who is Siemens Healthcare?

5. 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

6. Biotechnology Industry: general facts • 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

7. 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

8. 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

9. 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

10. Why do Regulations Exist To protect the public health and safety! It’s no more complicated than that!

11. 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

12. 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.

13. 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

14. Business Situation/Problem Siemens Healthcare Produces Paper and Diagnostic Tests

15. 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

16. 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

17. 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

18. 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

19. 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

20. EBR Vendor Comparisons Type a brief overview or summary of your project here.

21. Vendor Criteria • Research reputation of the vendor • How frequently does the vendor update technology • What types of continued support are provided • Other Categories outlined on table Best Vendor Criteria • Instant GMP • MAR-Kov CMS

22. 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

23. 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

24. 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

25. 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

26. 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

27. Benefits Since 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.

28. 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.

29. 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

30. 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

31. 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)

32. 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

33. 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 – Cost Cost or 5.8 million – 2.3 million = 1.5 2.3 million

34. 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

35. Thank You! That wasn’t bad wasn’t it?

36. 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 ShrinkingMargins.12 Jan. 2004 • Laudon, Kenneth and Lauden, Jane: Management Information Systems. 2012.