Checklists
Practical, use-them-tomorrow checklists for CSV, FDA Part 11, and the full V-model.
A checklist turns a regulatory expectation into items you can tick off against a real system. Ours cover the full CSV deliverable set under GAMP 5 and the 21 CFR Part 11 controls for electronic records and signatures — each item stating not just what is required but what it has to demonstrate to someone inspecting it.
- checklistCSV Validation Checklist — the 26-deliverable master listThe full controlled deliverable set for GAMP 5 Second Edition CSV — with applicability by GAMP category and CSA rigor selectors.Read it
- checklistFDA 21 CFR Part 11 Compliance ChecklistPractical Part 11 checklist covering electronic records, electronic signatures, audit trails, and controls.Read it
What makes a checklist useful rather than reassuring
Most compliance checklists list document titles. That tells you what to produce and nothing about whether what you produced will survive scrutiny. Each item here states what it must demonstrate — the audit-trail item is not 'have an audit trail', it is that the trail must be computer-generated, capture the previous value on change, and be impossible for a user to disable.
Where an item only applies to certain systems, it says so. An item left out with a written rationale is defensible; an item simply missing is a finding.
Published in full, with a working copy
Every checklist is on its page in full — not behind a form, because a checklist nobody can read is not much use to anyone, including us. The form beside it offers the working copy: the same list as a spreadsheet with columns for applicability, owner, evidence location and status, which is the version you actually take into an audit.
Explore all resource types
Turn the reading into a plan.
Book a demo, or ask a validation lead a quick question on WhatsApp.
- We reply within one business day
- We run your URS live on the call
- You get a clear plan for your system