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Part 11 Compliance. FDA will inspect Part 11 controls relating to drugs as they are described in the ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (August 2003)

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Part 11 compliance
Part 11 Compliance

  • FDA will inspect Part 11 controls relating to drugs as they are described in the ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (August 2003)

  • Findings from upcoming inspections will help us evaluate industry’s current compliance and understanding of Part 11 in light of the guidance (now over 6.5 years since finalized)

  • FDA may use the inspectional findings as part of its reevaluation of Part 11 regulation, guidance, etc.

  • FDA may take appropriate enforcement action for issues raised during these inspections


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