Regulated teams need controlled records, approvals, training evidence, audit trails, retention rules, and electronic signature support.
Core Platform Features
- Role-based access control
- Approval workflows and controlled release
- Audit trail for edits, approvals, and acknowledgements
- Training records tied to the exact SOP version
- Retention, export, backup, and recovery controls
- Electronic signatures where required
FDA Part 11 in Practice
Applies when electronic records or signatures are used in contexts covered by predicate rules. Requirements: audit trail with timestamps and user identity, controlled access, signature records tied to the specific version, record integrity.
ISO Quality Systems
Focus on controlled documented information: which version is current, who approved it, what changed, and whether operators were trained on the right revision.
The Most Common Compliance Gap
Teams write detailed procedures but cannot produce: complete change history, training records linked to the specific version, or approval records with timestamps.
Originally published at claudiasop.com
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