Industry Coalition on 21 CFR Part 11

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 industrys 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.