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Electronic Records; Electronic Signatures Public Meeting Docket No. 2004N-0133

Electronic Records; Electronic Signatures Public Meeting Docket No. 2004N-0133. Kenneth Kornfield, Associate Director, Global Quality Jacques Mourrain, Associate Director, Corporate Compliance Krista Woodley, Manager, Global Quality. The current version of part 11 has been useful to Genentech.

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Electronic Records; Electronic Signatures Public Meeting Docket No. 2004N-0133

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  1. Electronic Records; Electronic Signatures Public MeetingDocket No. 2004N-0133 Kenneth Kornfield, Associate Director, Global Quality Jacques Mourrain, Associate Director, Corporate ComplianceKrista Woodley, Manager, Global Quality

  2. The current version of part 11 has been useful to Genentech. • We acknowledge the premise of part 11 and the potential effectiveness of ERES. • Genentech has accrued significant benefits from our implementation. ERES has enhanced quality while increasing efficiency in areas such as: • Electronic data capture for clinical data management • Electronic production records • Electronic safety reporting • Electronic document management

  3. We strongly support the FDA’s desire to re-examine the rule and evaluate potential changes. • Consistent with FDA’s guidance, we understand and agree that risk-based approaches should be used by regulated companies: • Analyze processes; understand and document risks • Identify GxP/predicate records • Implement controls to mitigate risks

  4. We categorized the questions asked in the Request for Comments and answered generally using these three categories: • Predicate Rules: Part 11 requirements are addressed by existing rules • Quality Systems: Part 11 requirements are addressed within general and specific Quality Systems requirements • Technology: System design and implementation should not be addressed by the regulations

  5. Categorization of questions (examples)

  6. Proposal - Simplify: • Electronic Records and associated Electronic Signatures may be used anywhere that records are required by predicate rules, provided controls are in place to ensure electronic records are accurate, attributable and secure when they are created, and throughout their required retention period.

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