Compliance
Inspection-ready every day - not the week before the audit.
ARISENTO is designed to support 21 CFR Part 11, EU GMP Annex 11 and ALCOA+ data integrity. Validation for your intended use is performed by you, in your environment - with our documentation and tools.
| Requirement | How ARISENTO supports it |
|---|---|
| Audit trail Part 11 §11.10(e), Annex 11 §9 | Append-only, enforced by the database: who, when, old value, new value, reason. The application's database account cannot change, delete or truncate it. |
| Electronic signatures §11.50, §11.70, §11.100, §11.200 | Re-authentication on every signature, signature meaning and manifestation, identity verification and certification of each signer. |
| Access control §11.10(d), §11.300, Annex 11 §12 | Seven roles, two-factor sign-in (Admin always, QA by default), password policy and aging, lockout, session lock; a credential change ends all sessions. |
| Data integrity ALCOA+ | Reason for every correction, second-person verification of imports, reviewed raw files kept with their fingerprint, immutable development records. |
| Record retention §11.10(c), GLP | Read-only access to all records and the audit trail, also after licence expiry; exports to PDF and Excel. |
| Controlled output §11.10(b), §11.10(e) | Every print, PDF and export recorded in the audit trail with user, time and record - controlled copies an inspector can trace. |
| Bioanalytical criteria ICH M10 | Run acceptance, repeats and ISR per ICH M10, or your SOP values per study. |
| AI governance Annex 11 §10 change control | Local model by default. Optional cloud AI (hybrid) only through a configuration request, connection test and QA approval with e-signature; every cloud request logged, immediate kill switch. Rule-engine verdicts final, cited and verified sources, AI output marked advisory. |
Validation pack
- Control mapping: Part 11, Annex 11, ALCOA+, GDPR
- User requirements with traceability to tests
- Automated OQ runner and installation checks
- UAT checklist for your acceptance testing
- Release notes with updated validation evidence
Shared responsibility
- Autofai: secure design, technical controls, release validation evidence
- You: IQ/OQ/PQ in your environment, with our support
- You: site SOPs, user management, training records
- You: backups off the server and restore tests
Walk through the controls with your QA team
A 45-minute walkthrough of method development, AI Data Review and the compliance controls - with your own run files.