Frameworks & Templates
The operating frameworks and templates behind our products and services — CSA, GAMP 5, AI validation, AI governance, audit readiness, IQ / OQ / PQ.
A framework is the operating model behind a practice — how decisions get made, in what order, and on what basis. Ours cover Computer Software Assurance, GAMP 5 Second Edition, AI validation against the draft Annex 22, AI governance, audit readiness, and the IQ/OQ/PQ protocol structure.
- frameworkCSA Framework — from paper to practiceThe end-to-end Computer Software Assurance operating model — risk profiling, test-strategy selection, vendor-evidence leverage, and audit posture.Read it
- frameworkAI Validation Framework — Annex 22 alignedHow to validate AI systems used in GxP-regulated processes: model card, eval set, deterministic guardrails, HITL policy, drift, fallback.Read it
- frameworkAI Governance Framework for Life SciencesPolicies, model registry, use-case intake, risk classification, red-teaming and drift — designed for regulated environments.Read it
- templateIQ / OQ / PQ Protocol TemplatesBattle-tested IQ, OQ and PQ protocol templates — configurable to your system class and CSA risk.Read it
- frameworkAudit Readiness FrameworkRepeatable audit readiness across GxP systems — mock inspections, evidence-pack drills, RTM sanity, Part 11 posture.Read it
Framework or checklist?
A checklist tells you what has to exist. A framework tells you how to decide — which risk level a requirement carries, which assurance activity follows from it, who approves what, and what the rationale has to show. You need both, and most organisations have the checklist and not the framework.
That is usually why a CSA adoption stalls: the policy changed, the templates did not, and nobody agreed what an acceptable rationale looks like before the first package reached QA.
Built from delivery, not from the guidance documents
These describe how the work is actually run, including the parts that commonly go wrong. The CSA framework spends as much space on why transitions fail procedurally as on the risk model itself, because that is where the time goes.
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