What the checklist covers
The workbook has two tabs. An Instructions tab explains the Ready / Gap / N-A scoring and why retrieval time matters. The checklist tab walks 20 things an FDA or MHRA investigator typically asks for — each with a Status dropdown, a column for where the evidence lives and how fast you can produce it, and an owner.
Totals count themselves, so you can rehearse the inspection, close the Gaps, and re-run before any scheduled or for-cause visit.
- The QMS itself — quality manual, responsibilities, and management review
- Documents and records — current SOPs, training-to-version, and fast retrieval of any controlled record
- The event engine — CAPA, deviations, change control, and complaints, traced end to end
- Oversight — internal audits, supplier qualification, data-integrity audit trails, and access review
- A Ready / Gap / N-A dropdown, a retrieval-time note, and an owner on every item, with automatic totals
Why retrieval time is the real test
Inspections are not won on the existence of records — they are won on the ability to produce them. An investigator asks for the CAPA behind a finding, the training record for the operator, the audit trail for a result; the speed and completeness of your answer signals whether you actually control your quality system or merely store it.
That is why this checklist adds a retrieval column: not just do you have it, but can you put your hand on the complete, current version in minutes. A record you cannot produce on request reads, to an inspector, like a record you do not control.
From a checklist to always inspection-ready
The Gaps a readiness checklist finds are usually retrieval Gaps — the evidence exists, but it is scattered across inboxes, drives, and spreadsheets. Complere closes those by keeping the records connected: CAPA, deviations, change control, documents, training, and audits live in one workspace, each linked to the others, each with an immutable ALCOA+ audit trail.
So when an investigator asks for the CAPA behind a finding, the training that proves competence, or the audit trail for a record, your team produces it from the workspace it was created in — with the trail attached — instead of reconstructing it under inspection pressure.
