「21-cfr-11」の検索結果

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.

日本語の概要は準備中です。原文の説明を表示しています。