What Part 11 requires - and how SKUsafe handles it.
Electronic records
- Controlled system access
- Audit trails tied to each record
- Record retention and version history
- Ability to generate accurate, complete copies
Electronic signatures
- Unique user identification
- Signature meaning captured at the moment of action
- Date and time stamps
- Attribution tied to the signed record
Workflow discipline
- Stage-gated approvals
- Role-based access
- Cross-functional sign-off
- Inspectable on demand
See SKUsafe on your own SKUs.
30-minute walkthrough on your real data - formulation, labels, supplier control.