FDA Public Meeting on Electronic Records and Signatures June 11, 2004

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FDA Public Meeting on Electronic Records and
SignaturesJune 11, 2004

• Presentation of the Industry Coalition on 21CFR
  Part 11
• Alan Goldhammer, PhD
• Chair of the Coalition

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Industry Coalition on 21 CFR Part 11
Advanced Medical Technology Association Americas
Blood Centers Animal Health Institute Biotechnolog
y Industry Organization Consumer Healthcare
Products Association Cosmetic, Toiletry, and
Fragrance Association Council for Responsible
Nutrition Council on Radionuclides and
Radiopharmaceuticals Generic Pharmaceutical
Association Medical Device Manufacturers
Association National Electrical Manufacturers
Association National Food Processors Association
National Grain and Feed Association Pharmaceutica
l Research and Manufacturers of America
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Coalition Background

• Formed in mid-2000
• Goal Provide a Broad Industry Perspective on
  the Regulation to FDA
• Actions Provided Comments to FDA on a Variety
  of Issues including
• Scope
• Validation
• Time Stamps

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Effect of the Regulation on Business Processes

• It is intended to enable electronic submission
  without paper copies, and review of components
  of marketing applications,and related documents
• It is intended to facilitate industry and FDA use
  of more efficient and effective business
  processes e-Records and e-Signatures replace
  many paper-based processes.
• It is intended to aid in avoiding mistakes and
  fraud, preserving and protecting electronic GxP
  records, and maintaining product quality and
  data integrity.

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Effect of the Regulation (contd)

• Leads to harmonization of e-Records and
  e-Signatures within and across agencies and the
  regulated industries
• Has served as a general set of requirements to
  software vendors.
• Has advanced awareness of this issue

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Problems with the Regulation

• Too Prescriptive in Terms of Technology
• Difficult to Interpret
• Uncertain Cost (gt 2 billion estimated by the
  pharmaceutical industry)

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Other Federal Approaches

• Government Paperwork Elimination Act (GPEA), Pub.
  L. No. 105-277, 1701-1710 (1998)
• OMB Guidance on GPEA, agency considerations of
  cost, risk, and benefit, as well as any measures
  taken to minimize risks, should be commensurate
  with the level of sensitivity of the transaction
• "Electronic Records and Signatures in Global and
  National Commerce Act" (E-SIGN) (Pub.L. 106-229,
  1 (2000)

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LEGAL CONSIDERATIONS IN DESIGNING AND
IMPLEMENTING ELECTRONIC PROCESSES A GUIDE FOR
FEDERAL AGENCIES

• http//www.usdoj.gov/criminal/cybercrime/eprocess.
  htm

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Where Should We Head??

• In accordance with the OMB Guidance on GPEA,
  agency considerations of cost, risk, and benefit,
  as well as any measures taken to minimize risks,
  should be commensurate with the level of
  sensitivity of the transaction.  Low-risk
  information processes may need only minimal
  safeguards, while high-risk processes may need
  more.  In the context of legal and litigation
  risks, "low-risk information processes" are those
  that have a small chance of generating
  significant liability, financial impact, or
  litigation that would have a significant effect
  on the agency.

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Some Industries Already Have Moved in this
Direction

• Foods Hazard Analysis and Critical Control
  Point (HACCP http//www.cfsan.fda.gov/lrd/bghaccp
  .html)
• Medical Devices Quality Systems ("Each
  manufacturer shall establish and maintain a
  quality system that is appropriate for the
  specific device(s) designed or manufactured, and
  that meets the requirements of this part." )
• Process Analytical Technology (PAT) emerging
  standard for the pharmaceutical industry.

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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.

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New Scope and Application - 2003

• More Realistic Risk Based Approach
• Withdrawal of Compliance Policy Guide
• Recognition of the Need to Search for Practical
  Solutions

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Risk Based Approach in Part 11 Final Guidance

• Current Part 11 Final Guidance emphasizes role of
  risk assessment for some Part 11 controls
• validation
• audit trails
• record retention

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Risk Based Approach in Part 11 Final Guidance

• We (FDA) recommend that you base your approach
  on a justified and documented risk assessment and
  a determination of the potential of the system to
  affect product quality and safety, and record
  integrity Lines 207-209

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What is a Risk Based Approach to Part 11

• Dont limit use of risk based approach.
• Organizations should be allowed to apply their
  risk based approach to any area of electronic
  records
• There are a multitude of risk-based approaches
  and tools
• FDA should not specify any particular approach or
  tools to be used.
• If a risk based approach is used then it should
  be defined and documented.

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Key Issues with E-Records

• Record Security
• Authenticity
• Authority/Accountability

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E-Record Regulatory Paradigm

• Build Upon Existing Predicate Regulations
• Use Hardware, Software, Best Business Practices
  
• Reconsider the Need for the Current Part 11
  Regulation from the practical and enforcement
  points of view and in light of the lessons
  learned to date.