Results for “electronic-signatures”

Implement electronic signatures compliant with 21 CFR Part 11 Subpart C and EU Annex 11. Covers signature manifestation (signer, date/time, meaning), signature-to-record binding, biometric vs non-biometric controls, policy creation, and user certification requirements. Use when a computerized system requires legally binding electronic signatures for GxP records, when replacing wet-ink signatures in regulated workflows, when implementing batch release or document approval workflows, or when a regulatory gap reveals missing signature controls.

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Document control for medical device QMS, covering numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflows, and electronic signature compliance.

The English summary is being prepared. Showing the original description.