1. Industry Coalition on 21 CFR Part 11 Recommendations for Achieving Compliance with the Electronic Records and Electronic Signatures Regulation

2. Who are we? Advanced Medical Technology Association (AdvaMed) Consumer Healthcare Products Association (CHPA) Cosmetic, Toiletry and Fragrance Association, (CTFA) Council for Responsible Nutrition (CRN) Generic Pharmaceutical Association (GPhA) National Food Processors Association (NFPA) Pharmaceutical Research and Manufactures of America (PhRMA)

3. Value of the Regulation FDA has recognized and facilitated a paradigm shift

4. Value of the Regulation Enables electronic submission – without paper copies, and review of components of marketing applications,and related documents Facilitates industry and FDA use of more efficient and effective business processes: e-Records and e- Signatures replace many paper-based processes. Aids in avoiding mistakes and fraud, preserving and protecting electronic GxP records, and maintaining product quality and data integrity.

5. Value of the Regulation Leads to harmonization of e-Records and e- Signatures within and across agencies and the regulated industries Helps provide clear requirements specifications to key commercial software suppliers.

6. Coalition Position Support general principles of Regulation Implementation highlights unexpected problems Scope broader than initial intent Diversity of interpretation leads to –compliance uncertainty –deferral of IT investment Dialogue with FDA best way to workable compliance

7. Recommendations We have six.

8. Electronic Records and Signatures Same requirements for electronically signed e- records and paper records. E-signature defines creation of e-record subject to audit trail. Continue to accept hand signed and dated computer printouts. PDF image acceptable as electronic form of “raw data”.

9. Implementation Timing Current validated systems adequate to produce safe, high quality products. Require compliance as systems replaced or upgraded as part of their normal life cycle. To replace or upgrade outside normal life cycles projects multi-billion-dollar cost. Major cost ultimately for the consumers who purchase the products of the affected industries.

10. Implementation Timing We propose: –existing applications, often a mix of electronic and paper-based records/signatures, and are compliant with GxPs, incorporate aspects necessary to comply as part of normal replacement/upgrade cycle –each company develops a replacement/upgrade plan in line with normal system life cycles –update plan periodically to reflect progress – make progress reports available for FDA inspections.

11. Risk/Benefit Driven Approach Apply control mechanisms for e-Records proportional to potential impact on public health. Use hierarchical approach to implementation for applications, data and reports, similar to SUPAC. Develop benefit-driven approach acceptable to FDA and regulated industries.

12. Risk/Benefits Driven Approach We propose: –rank affected applications according to benefits expected from application of Regulation. Similar ranking for data (by type) and documents (by type, e.g., SOPs, reports, etc)..

13. Commercially Available Software Regulated industries rely on mature commercial products from market leaders. Industry conservative regarding adoption of new technologies. Companies depend on vendor software and its ability to facilitate compliance. Few companies prepared to revert to custom in- house software development.

14. Commercially Available Software Vendors need 18-36 months for major new software releases; this limits industry’s ability to respond rapidly. In the early stages there may be problems with the reliability and scalability of these products.

15. Commercially Available Software We propose: –companies list systems with realistic times for adopting new off-the-shelf systems that require minimum customizing. The Coalition will cooperate with vendors to facilitate rapid development of the required products

16. Long-term Archiving Continuous advances in electronic storage media and IT standards render current technology obsolete and eventually not maintainable. New generations of database technology generally appear in 10-year cycles. A complex task requiring the agency and the regulated industries working together to develop a viable approach.

17. Economic Impact Analysis Although some elements of the Regulation are described as being voluntary, in practical terms they are required. FDA should conduct an Economic Impact Analysis (EIA) to assess the additional regulatory burden and to guide appropriate implementation.

18. Economic Impact Analysis EIA should include economic and public health benefits gained by implementing the Regulation. Regulatory requirements must be consistent with other government initiatives, such as the Paperless Environment 2002, Paperwork Reduction Act, the Mutual Recognition Agreement (MRA), and new or pending legislation.

19. Guidance Effective compliance requires clear FDA guidance to the regulated industries and in compliance policy guides. –Guidance should consider the six Coalition recommendations. –Guidance should describe “good faith” compliance expectations. –Regulated industries need opportunity to provide input early in development of guidance.

20. Summary The Coalition will, -Lead regulated industry, cooperate with FDA in realizing the benefits of the Regulation through a common interpretation. -Provide qualitative and quantitative data for constructive use to work with the FDA and other regulatory agencies here and abroad. –Provide a means for coalition members and others to benchmark current best practices, both procedural and technical.