© 2004, Genentech

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

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© 2004, Genentech

• 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

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© 2004, Genentech

• 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

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© 2004, Genentech

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

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© 2004, Genentech

Categorization of questions (examples)

Predicate

Question Requirement outside part 11

Should Part 11 address record conversion? Record retention/copying (Part 211 Subpart J)

Should audit trail requirements include safeguards designed and implemented to deter, prevent, and document unauthorized record creation, modification and deletion?

Security

(Part 211 Subpart D)

Quality Systems

Should we retain the validation provision under 11.10(b) required to ensure that a system meets predicate rule requirements for validation?

Validation system

Should Part 11 address investigations and follow up when security breaches occur?

Deviation/CAPA system

Technology

Should Part 11 continue to differentiate between open and closed systems?

Unspecified elsewhere

Should Part 11 be modified to incorporate concepts, such as configuration and document management, for all of a system’s software and hardware?

Unspecified elsewhere

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© 2004, Genentech

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.