Compliance References
| Capability | Regulatory basis |
|---|---|
| Electronic signature | 21 CFR 11.100(b) |
| Audit trail | 21 CFR 11.10(e) |
| Access control | 21 CFR 11.10(d) |
| Idle lock & re-authentication | 21 CFR 11.300(b) |
| Electronic batch records | 21 CFR 211.188 |
| Deviation management | 21 CFR 211.192 |
| Training records | 21 CFR 211.25 |
| Change control | EU GMP §5.24 |
| System validation (IQ/OQ/PQ) | EU GMP Annex 11 · GAMP 5 |