Deviations, CAPA, document control, risk assessments, complaint handling, and training management — all with cryptographic audit trails and ALCOA+ compliance.
Track and resolve data integrity deviations — late entries, corrections, deletion requests, format violations.
Full corrective and preventive action lifecycle from initiation through effectiveness verification.
In-app document management with version control, review workflows, and training tracking. 8 SOPs seeded.
ICH Q9-compliant risk assessments with FMEA, HACCP, FTA, PHA, and HAZOP methodologies.
Full complaint lifecycle from intake through investigation, resolution, and regulatory reporting.
GxP training programs, enrollments, completions, and role-SOP matrix management.
| Module | FDA 21 CFR Part 11 | ALCOA+ | ISO 13485 | ICH Q9/Q10 |
|---|---|---|---|---|
| Deviations | 11.10 | Accurate, Complete | 8.5.2 | Q9, Q10 |
| CAPA | 11.10, 11.70 | Complete, Enduring | 8.5.2, 8.5.3 | Q9, Q10 |
| Document Control | 11.10, 11.80 | Attributable, Original | 4.2, 4.3 | Q9, Q10 |
| Risk Assessment | 11.10 | Complete | 7.1, 7.2 | Q9, Q10 |
| Complaints | 11.10, 11.70 | Complete, Available | 8.2.1, 8.2.2 | Q9, Q10 |
| Training | 11.10(i) | Attributable | 6.2 | Q9, Q10 |
Book a demo and see the complete QMS suite in action.