FDA Part 11 Public Meeting Washington, DC June 11, 2004

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FDA Part 11 Public MeetingWashington, DCJune
11, 2004
Narrowing The Scope Part 11
Paul DEramo Executive Director Worldwide Policy
Compliance Management Quality Compliance
Services
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New Approach to Part 11

• Top - Down Approach
• Focuses on the Predicate Rule as opposed to the
  all electronic records created by a firm
• Risk-Based Approach

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Narrowing The Scope

• Definition of Part 11 Records
• Appropriate Use of Audit Trails
• Records Retention
• Legacy Systems

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Scope of Part 11

• Part 11 applies
• When persons choose to use e-records in place of
  paper
• Part 11 does not apply
• When persons use computers to produce paper
  printouts and rely on paper to perform their
  regulated activities

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RegulationDefinition - Electronic Record

• Any combination of text, graphics, data, audio,
  pictorial, or
• other information
• represented in digital
• form that is created, modified, maintained,
  archived, retrieved,
• or distributed by a computer system.

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GuidelineDefinition - Electronic Record

• Records Required by Predicate Rules
• Electronic format used in place of paper
• Electronic format in addition to paper and relied
  on to perform regulated activities
• The Agency may take your business practices into
  account
• Must document your procedure in SOPs

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Out-of-scope Records and signatures

• REMEMBER Systems may still require validation,
  qualification, calibration, and other measures
  and controls aimed at ensuring correct operation
  and record integrity, based on predicate rule
  requirements, and the potential impact of that
  system on product safety and quality.

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Out-of-scope Examples

• Any electronic signatures NOT required by
  predicate rules, and other superficially similar
  cases such as identification of individuals,
  acknowledgement of steps or actions, or
  logging-on to a system

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Out-of-scope Examples

• For systems generating large amounts of
  intermediate data which is used to generate the
  regulated records upon which quality decisions
  are based, only those records required to meet
  predicate rule requirements, or submitted to
  Agency, are in scope, and not all data generated
  and held by such systems. (Example follows).

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Out-of-scope Examples

• Example A validated system measures two million
  capsule weights for a single batch. The system
  generates a curve showing that batch weight
  distribution falls within validated norms. The
  individual data points are not Part 11 records.
  The expectation of the predicate rule 21 CFR
  211.188 is met.

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Summary

• Top - Down Approach Focus on the Predicate Rule
  as opposed to the all electronic records
• Use a Risk-Based approach as per the guidance
• Enable the use of new technology as originally
  intended
• Meet FDA expectations for security and integrity
  of records