Industry Coalition on 21 CFR Part 11

Recommendations for Achieving Compliance with the

Electronic Records and Electronic Signatures Regulation

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)

Value of the Regulation

FDA has recognized and facilitated a paradigm shift

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.

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.

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

Recommendations

We have six.

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”.

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.

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.

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.

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)..

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.

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.

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

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.

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.

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.

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.

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.