Free resources
The reading every pharma QA team is doing this quarter — packaged.
No 14-slide deck. No vendor pitch. The two checklists most useful for pharma teams preparing for EU AI Act enforcement and 21 CFR Part 11 audits, written by the team that built the platform underneath them.
21 CFR Part 11 Compliance Matrix
A § -by-§ checklist for vendor evaluation, internal audit, or URS authoring.
- Every § (11.10 through 11.300) mapped to a concrete system requirement
- Vendor RFI / RFP-ready format
- Print + use alongside an audit
- Free · 6 pages · PDF
EU AI Act Self-Assessment Checklist
A 30-minute checklist for pharma teams preparing for 2 August 2026 enforcement.
- Annex III categorisation walk-through
- Article 9 / 11 / 13 / 14 obligations summary
- Article 72 + 73 post-market mapping
- Free · 5 pages · PDF
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