GAMP 5 templates, 21 CFR Part 11 / EU GMP Annex 11 control matrices, and the legal pack we ship to procurement. Read the source — every customer starts here.
Six lifecycle templates fork-and-fill: requirements, risk, plan, IQ/OQ/PQ, traceability and final report.
Structured URS template with sections for functional, regulatory, performance and interface requirements.
ICH Q9-style risk assessment template with FMEA scoring, risk priority numbers and mitigation tracking sections.
Phase-gated validation plan with deliverable matrix, role assignments, acceptance criteria and signature blocks.
Three protocols with measurable pass criteria, evidence capture fields and signed-execution blocks.
Cross-reference URS ↔ FRS ↔ Test Cases ↔ Risks. Manual fill — wire-up to your validation package.
Final validation report with deviation summary, risk re-evaluation and acceptance recommendation sections.
21 CFR Part 11, EU GMP Annex 11 and the GAMP 5 lifecycle map — control by control, with platform evidence.
Section-by-section mapping of every Part 11 control we currently implement, with audit-trail evidence pointers.
All seventeen Annex 11 sections mapped to platform controls and the customer responsibilities they leave behind.
GAMP 5 (2nd ed.) categorisation and lifecycle phases as modelled in the platform.
The Terms of Service and the Data Processing Agreement that apply to every contract are published online. Below: DPA and MSA templates for individually negotiated agreements, plus a business case template. Individually agreed provisions take precedence.
Template for an individually negotiated GDPR Art. 28 agreement, aligned with the standard DPA: TOMs, sub-processors, audits, return and deletion.
Template for an individually negotiated master agreement, aligned with the standard Terms: GxP responsibilities, AI, Data Act switching, German law.
Structured business case for procurement and validation leadership: scope, benefits, risks, total cost of ownership.
Customers fork these templates inside their tenant, swap in their SOPs, and ship. The PDFs above are the same source we hand to inspectors.