This is a ready-to-use decision record. It captures, for one system, the per-aspect judgment about whether vendor, factory acceptance test (FAT), or site acceptance test (SAT) documentation can stand as qualification (verification) evidence under a risk- and science-based commissioning and qualification program, or whether the aspect needs fresh verification at the site. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through your normal review and approval. A worked filled specimen follows. Confirm each cited standard and regulation against the current source before you rely on it. This content is general educational reference, not legal or regulatory advice; adapt it to your own quality system.
Why this record exists
Reusing existing evidence, sometimes described as building on work already done, is where a science-based C&Q program saves cost and time. It is also where programs get cited, because teams accept vendor paper that does not actually establish anything. The reuse decision is a documented, defensible judgment, not an assumption. This record is the place that judgment lives so that, in an inspection two years later, anyone can see what you leaned on and why it was acceptable. The controlling ideas come from ASTM E2500 (verification of critical aspects) and EU GMP Annex 15, which allows qualification work done during FAT to feed the qualification program when the results are shown to be unaffected by transport and installation and the supplier and documentation are assessed.
Document control header
| Field | Entry |
|---|---|
| Record title | Vendor Documentation Reuse Decision |
| Record number | <<FILL: e.g. CQ-REUSE-014>> |
| System / equipment | <<FILL: system name and asset ID>> |
| Project / C&Q plan reference | <<FILL: C&Q plan or VMP number>> |
| Vendor / supplier | <<FILL: vendor name>> |
| Version | <<FILL: e.g. 1.0>> |
| Date | <<FILL: date>> |
| Prepared by (C&Q / SME) | <<FILL: name, role>> |
1. Supplier assessment basis
Reuse is only defensible when the vendor has been shown capable of producing reliable evidence. Record the supplier assessment that supports reuse before the per-aspect table.
| Field | Entry |
|---|---|
| Supplier assessment reference | <<FILL: assessment / audit report number>> |
| Assessment type | <<FILL: on-site audit / remote audit / questionnaire + evidence>> |
| Date and outcome | <<FILL: date; approved / approved with conditions / not approved>> |
| Quality system adequate for the evidence relied on | Yes / No / Conditional |
| Conditions or limitations on reuse | <<FILL: e.g. software records excluded pending code review>> |
If the supplier assessment does not support reuse, reuse is not available for this system; verify at the site and record that here.
2. Reuse eligibility gate (applied to every candidate document)
A candidate document is only eligible for reuse when all of the following hold. Fail any one and the aspect goes to site verification.
- The document covers a defined critical aspect that traces to a CQA, a CPP, or a direct patient-safety risk.
- The acceptance criteria in the vendor test were predefined, GMP-relevant, and approved before execution, not generic engineering signoffs.
- The record meets ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available). A result written up later from memory is not reusable.
- Quality oversight was proportionate to the criticality (witnessed or reviewed for critical aspects).
- The result is not invalidated by later transport, installation, or integration; where it could be, a site confirmation is defined.
3. Per-aspect reuse decision table
One row per critical aspect. The decision column is the point of the record.
| Critical aspect (traces to) | Candidate evidence | Vendor acceptance criteria GMP-relevant? | ALCOA+ met? | Invalidated by transport/install/integration? | Decision |
|---|---|---|---|---|---|
<<FILL: aspect, e.g. flow rate accuracy (CPP)>> | <<FILL: FAT test ID / cert>> | Yes / No | Yes / No | No / Partial / Yes | <<FILL: Reuse / Reuse + site confirm / Site verification required>> |
<<FILL>> | <<FILL>> | <<FILL>> | |||
<<FILL>> | <<FILL>> | <<FILL>> |
Decision key: Reuse (accept the vendor record as verification evidence, no re-execution); Reuse + site confirm (accept the vendor record but confirm in place at SAT, for example a calibration verified after shipping); Site verification required (the vendor evidence cannot carry the aspect, verify fresh at the site).
4. Gap analysis
State plainly what the vendor testing did not cover and how the site program closes it. This is the half teams skip.
| Gap (what vendor testing did not establish) | Why it matters | Closed by (site activity + reference) |
|---|---|---|
<<FILL: e.g. integration with site DCS and alarms>> | <<FILL: function only exists once integrated>> | <<FILL: site verification protocol ID>> |
<<FILL: e.g. performance at site process load>> | <<FILL: FAT ran at ambient / no product>> | <<FILL: performance verification ID>> |
5. Acceptance criteria for this record
- Every critical aspect for the system appears in the table with an explicit decision and rationale.
- No aspect is marked Reuse without a supporting supplier assessment and an eligibility-gate pass.
- Every gap has a named closing activity with a reference, and no gap is left open at release.
- The SME and Quality approvals below are present before the evidence is cited in the Acceptance and Release report.
6. References
ASTM E2500, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment (current revision). EU GMP Annex 15, Qualification and Validation (reuse of FAT work in the qualification program where justified). ICH Q9(R1), Quality Risk Management (the risk basis for scoping). FDA Guidance, Process Validation: General Principles and Practices (2011), Stage 2. MHRA GxP Data Integrity Guidance and Definitions, and PIC/S PI 041, for the ALCOA+ expectations on reusable records.
Confirm the current version and clause numbers of each reference before issue.
7. Decision and approvals
| Role | Name | Signature | Date | Statement |
|---|---|---|---|---|
| Subject matter expert | <<FILL>> | Confirms the per-aspect decisions are technically sound and gaps are closed. | ||
| Quality Assurance | <<FILL>> | Confirms the supplier basis, the eligibility gate, and the approach are acceptable. | ||
| System / process owner | <<FILL>> | Accepts the reuse basis for the system in service. |
8. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Filled specimen
The following shows the record completed for an example chromatography skid. Company, system, and numbers are illustrative; replace them with your own.
System: Preparative chromatography skid CHR-SKID-02. Vendor: illustrative equipment supplier. Supplier assessment: SA-2026-031, on-site audit, approved, no reuse limitations.
Per-aspect decisions:
| Critical aspect (traces to) | Candidate evidence | Vendor AC GMP-relevant? | ALCOA+ met? | Invalidated by transport/install/integration? | Decision |
|---|---|---|---|---|---|
| Flow rate accuracy across range (CPP) | FAT-07, witnessed, limits +/-2% | Yes | Yes | No | Reuse + site confirm at SAT |
| UV detector wavelength accuracy (CPP) | FAT-09 + calibration cert (traceable) | Yes | Yes | Partial (post-shipping) | Reuse + site confirm |
| Conductivity sensor calibration (CPP) | Vendor cert, traceable, in date | Yes | Yes | Partial | Reuse cert; verify in place at SAT |
| Skid integration with site DCS and alarms | None (not connected at vendor) | n/a | n/a | Yes | Site verification required |
| Cleaning cycle at process conditions (CQA: carryover) | Partial FAT run at ambient | No (not at process conditions) | Yes | Yes | Site performance verification required |
Gap analysis: two aspects (DCS integration, cleaning at process conditions) were not established by the vendor and are closed by site verification protocols VER-CHR-02-INT and VER-CHR-02-CLEAN. Three aspects are reused with a defined site confirmation after shipping.
Outcome: none of the five critical aspects was reused outright; three were reused then confirmed at SAT, two required fresh site verification. SME and QA approved the record before the Acceptance and Release report cited it.
Common inspection findings this record prevents
- A FAT package accepted whole, where the acceptance criteria were engineering signoffs that never tested the GMP-critical attribute.
- Vendor certificates reused with no supplier assessment establishing the vendor’s quality system.
- A calibration certificate reused with no traceability to a national standard, or out of date at execution.
- The all-or-nothing reflex: re-executing everything at the site (wasteful) or waving the whole vendor package through (indefensible), instead of a per-aspect call.
- A reuse decision made verbally, with no record an inspector can walk two years later.
- Integration or process-load aspects marked reused when they only exist once the system is installed and running at the site.
How to adapt this record
- Set your record number and link it to the system’s C&Q plan and the Acceptance and Release report.
- Attach or reference the supplier assessment; if there is none, reuse is not available, verify at the site.
- List every critical aspect from the criticality assessment, not a convenient subset, and give each an explicit decision.
- Close every gap with a named site activity before release; do not leave an open gap on a released system.
- Have the SME and QA sign before the evidence is cited anywhere downstream.