AI use. GxP compliant. Audit ready.
AI governance that auditors trust.
Practical SOPs and decision tools for life sciences teams that need to move from informal AI use to defensible quality-system controls.
01 / Practical
Written for the everyday decisions a quality system has to hold up.
02 / Defensible
Built around intended use, risk, qualification, oversight, and evidence.
03 / Ready
Editable Notion templates for a clear, credible implementation path.
A disciplined approach
Governance built for the real quality system.
Generic AI policies leave the difficult questions unanswered. GxP Guardrail gives QA and RA leaders a structured way to define appropriate use, assess risk, qualify tools, and preserve the documentation that matters.
Why GxP GuardrailGxP first, not generic AI
Controls reflect quality-system realities—from intended use and validation to review and records.
A clear six-gate decision path
Work through risk consistently, so each decision is traceable and proportionate to the use case.
Evidence your team can maintain
Keep oversight, qualification, and audit response material in the places your team already works.
The governance SOP pack