| Requirement | URS rev. 4 | Supplier A | Supplier B | Supplier C |
|---|---|---|---|---|
| 3.2.1 Operating range | −20…+55 °C | MetTR-118 §4.2 | MetSpec p.12 | Partial+45 °C only |
| 6.1.3 Data retention | 10 years | MetFS §2.4 | Conflict7 years, p.31 | Metp.14 |
| 6.1.7 Audit trail PDF/A | Required | MetOQ-23 | Metp.33 | GapNo evidence |
| 7.2.4 Part 11 e-signature | Required | MetFS §5.1 | Metp.38 | Metp.19 |
| 8.4.1 Changeover | < 15 min | Partial18 min, p.40 | Metp.45 | Metp.21 |
URS requires 10 years. Verifier agent confirms the conflict. Your decision is recorded and signed.
Each agent does one regulated job, works 24/7 and hands its output to a person to sign.
Splits specifications into testable, risk-tagged requirements.
Proposes GAMP 5 category and ICH Q9 risk per requirement.
Drafts IQ, OQ and PQ from URS, FS and your templates.
Keeps the traceability matrix live as a graph. No orphans.
Triages deviations and drafts CAPA with cited root cause.
Checks every record against all nine criteria, every cycle.
Matches vendor FAT/SAT and offers to your URS.
Scopes revalidation from the trace graph when anything changes.
Every requirement in a row, every document in a column, every cell backed by the page that proves it.
| Document | Says | Status |
|---|---|---|
| URS rev. 4 | 10 years | Requirement |
| Supplier A · FS | 10 years | Met |
| Supplier B · offer | 7 years | Conflict |
| Supplier C · offer | 10 years | Met |
Every status links to the exact page and clause. No citation, no status.
URS, FS, FAT, offers and certificates in one view, conflicts already marked.
Agents draft. A qualified person confirms, edits or rejects and signs.