This is a ready-to-use requirements traceability matrix (RTM) for a commissioning and qualification effort. It maps every user requirement to the single lowest sensible test that verifies it, and records the justification for reusing FAT or SAT evidence into IQ or OQ so you test once instead of three times. Build it before FAT, not after. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is educational reference content, not regulatory advice.
Why this matrix earns its place
Reuse of FAT/SAT evidence into qualification is a privilege earned with documentation, and the RTM is the document that makes it defensible. It shows an inspector, at a glance, that every URS line is covered exactly once, where it is verified, and why a FAT result can stand in for an IQ or OQ test. Without it, coverage gaps and duplications are invisible and the reuse argument collapses. See factory and site acceptance testing and commissioning and qualification under ASTM E2500.
Header
| Field | Entry |
|---|---|
| Matrix number | <<FILL: RTM-ID>> |
| Equipment / system | <<FILL>> |
| Related URS / FS / DS | <<FILL: document numbers>> |
| C&Q plan / VMP reference | <<FILL>> |
| Owner | <<FILL: C&Q engineer>> |
Column definitions
| Column | Meaning |
|---|---|
| Req ID | Unique requirement identifier from the URS |
| Requirement | The testable requirement text |
| Risk / critical aspect | Is this a critical aspect (impacts product quality, patient safety, or data integrity)? |
| FS / DS ref | Where the design satisfies it |
| Verified at | The lowest sensible test event: FAT / SAT / IQ / OQ / PQ |
| Reused in | The qualification stage that references the evidence instead of repeating it |
| Reuse justification | Why the evidence is valid and transport/installation-safe (the Annex 15 condition) |
| Status | Open / Verified |
Matrix
| Req ID | Requirement | Critical? | FS / DS ref | Verified at | Reused in | Reuse justification | Status |
|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | Y/N | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | Open |
Coverage check
| Check | Result |
|---|---|
| Every URS requirement mapped to at least one test | <<FILL: Yes / gaps listed>> |
| No critical requirement verified only by unwitnessed vendor testing | <<FILL>> |
| Each reused FAT result has a transport-sensitive SAT re-test or a documented rationale | <<FILL>> |
| Supplier assessment on file supporting reliance on vendor data | <<FILL: reference>> |
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (C&Q) | <<FILL>> | ||
| Reviewer (QA) | <<FILL>> |
Filled specimen
Example rows for a bioreactor skid.
| Req ID | Requirement | Critical? | FS / DS ref | Verified at | Reused in | Reuse justification | Status |
|---|---|---|---|---|---|---|---|
| URS-041 | Product-contact parts 316L, Ra <= 0.5 um | Y | DS-3.2 | FAT (material certs + inspection) | IQ | Material cannot change in transit; cert-based, stable | Verified |
| URS-052 | All I/O points correctly mapped | Y | FS-5.1 | FAT (full I/O check, QA witnessed) | OQ (component) | Executed under approved protocol; re-confirmed by SAT functional run | Verified |
| URS-060 | High-temperature interlock de-energizes heater within 2 s | Y | FS-6.4 | FAT then SAT re-test | OQ | Transport-sensitive; SAT re-test shows unaffected by shipping | Verified |
| URS-071 | Audit trail records changes with user ID and timestamp | Y | FS-8.2 | FAT (software test, QA + IT witnessed) | OQ / Part 11 evidence | Software config frozen; version verified identical at SAT | Verified |
| URS-088 | Compressed air dew point within ISO 8573-1 class per URS | Y | DS-4.1 | SAT (real utility) | IQ | Cannot be tested at vendor; site-utility specific | Verified |
| URS-096 | HMI displays temperature in C | N | FS-8.1 | FAT (screen verification) | OQ | Config verified; low risk; SAT confirms display unchanged | Verified |
The payoff is visible in the “Reused in” column: instead of re-running the I/O check and the interlock test a third time during OQ, OQ references the controlled FAT execution plus the SAT confirmation, and spends its effort on what genuinely needs site execution. Each reuse carries its own justification tied to the Annex 15 condition, so the argument survives an inspection.
Common inspection findings this matrix prevents
- No one can show which requirement each test covers, so gaps and duplications are invisible.
- FAT evidence reused into OQ with no recorded justification and no transport-sensitivity check.
- A critical requirement covered only by an unwitnessed, uncontrolled vendor test.
- Reuse claimed without a supplier assessment supporting reliance on vendor data.
How to adapt this matrix
- Import your URS requirements as rows before FAT, and assign each to its lowest sensible test event.
- Mark critical aspects; those get witnessing and the tightest reuse justification.
- For every reused FAT result, name the transport-sensitive SAT re-test or the rationale for stability.
- Run the coverage check at the end and resolve any gap before you rely on reuse.