Two quick self-checks for quality, validation and IT-compliance leaders in pharma, biotech, medical device and CRO. Answer a handful of questions and get an instant, tailored read on where you stand.
Self-check 1
AI-in-GxP readiness
Since the FDA’s first AI warning letter (April 2026), uncontrolled AI in a regulated process is a compliance concern on its own. Five questions to see how exposed you are.
1. Is AI or GenAI used anywhere in your GxP processes (quality, manufacturing, lab, documentation)?
2. Are your AI systems classified by intended use and process risk?
3. Is every AI-generated output reviewed and approved by qualified personnel before use?
4. Do you have AI governance SOPs and a validation approach aligned to GAMP 5 D11 / Annex 22?
5. Do any of your AI use cases fall under EU AI Act high-risk obligations?
See your results
Enter your name and email and we’ll show your personalized readiness band right away.
Almost there
Please answer all 5 questions to see your readiness band.
Strong
Your AI-in-GxP readiness posture looks solid. A periodic review keeps it inspection-ready as guidance evolves (CSA Feb 2026, Annex 22, EU AI Act).
Want an independent second opinion or a periodic review to confirm?
Some gaps
You have meaningful gaps an inspector could find. A fixed-scope assessment would prioritize the highest-exposure items and give you a board-ready plan.
High exposure
Several high-risk gaps stand out. We’d recommend a scoped readiness assessment soon — before your next inspection or audit — to close them in priority order.
Self-check 2
Data-integrity & CSA maturity
Audit trails, access control and risk-based assurance — five questions on the areas inspectors probe first.
1. Are audit trails enabled, protected, and routinely reviewed on your critical GxP systems?
2. Does every user have a unique account, with no shared logins on GxP systems?
3. Are GxP-critical spreadsheets and hybrid paper/electronic records under control?
4. Has your validation approach moved from document-heavy CSV to risk-based CSA?
5. Do your SOPs reference the current FDA CSA final guidance (Feb 2026, QMSR-aligned)?
See your results
Enter your name and email and we’ll show your personalized readiness band right away.
Almost there
Please answer all 5 questions to see your readiness band.
Strong
Your data-integrity & CSA maturity posture looks solid. A periodic review keeps it inspection-ready as guidance evolves (CSA Feb 2026, Annex 22, EU AI Act).
Want an independent second opinion or a periodic review to confirm?
Some gaps
You have meaningful gaps an inspector could find. A fixed-scope assessment would prioritize the highest-exposure items and give you a board-ready plan.
High exposure
Several high-risk gaps stand out. We’d recommend a scoped readiness assessment soon — before your next inspection or audit — to close them in priority order.
Want a deeper read than a self-check?
Our fixed-fee readiness assessments turn these answers into a board-ready gap report and a prioritized plan. No open-ended hourly billing.
Book a scoped assessment
