How to use this checklist
This is a Part 11 RFP scorecard, not a regulatory primer. Each section has the question to put into your RFP, the artifact to demand from the vendor, and the failure mode that should disqualify a response. Score each control area pass/fail against the artifact, not the marketing answer.
Buyer questions every vendor must answer
Most teams are not looking for abstract compliance claims. They want to know whether the system produces controlled records, maintains a readable history, limits access appropriately, and ties sign-off events to specific actions.
- Can the system show who approved what and when? (Artifact: signed audit trail export)
- Can we retrieve record history quickly during inspection? (Artifact: timed retrieval demo)
- How are signatures and user roles handled in daily workflows? (Artifact: e-signature SOP + screenshot)
- Does the vendor ship a Part 11 traceability matrix? (Artifact: TM mapping §11.10/§11.50/§11.300)
- What happens to the audit trail when a tenant is offboarded? (Artifact: retention + export procedure)
How Complere supports Part 11 compliance
Complere connects Part 11 requirements to daily quality operations: role-based access controls limit who can create, review, and approve records. Workflow sign-off points capture electronic signatures with re-authentication and intent. Time-stamped audit trails record every action, change, and access event across documents, CAPA, audits, training, and change control.
Electronic records, electronic signatures, audit trails, access controls, and system validation — Complere addresses all five core Part 11 control areas in a single governed platform.
