'electronic-signatures' 검색 결과

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.

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