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Free self-assessment · 2 minutes

Find your gaps before an inspector does

Two quick self-checks for quality, validation and IT-compliance leaders in pharma, biotech, medical device and CRO organizations. Answer five questions and get an instant read on where you stand. Nothing you answer is stored or sent unless you ask us to follow up.

AI-in-GxP readinessData integrity & CSA maturity
Self-check 1

AI-in-GxP readiness

Uncontrolled AI in a regulated process is now a compliance concern in its own right. 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?
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 FDA's final Computer Software Assurance (CSA) guidance?

This is a quick self-check, not an audit. It scores your answers in your browser and doesn't store them.

Want a deeper read than a self-check?

Our fixed-fee readiness assessment turns these answers into a board-ready gap report and a prioritized plan, with no open-ended hourly billing.

What happens next

  1. Tell us what you need: a role, a project, or both.
  2. A specialist in that area gets back to you within one business day.
  3. You get a screened shortlist of candidates, or a scoped plan for the project.

About the readiness assessment

If you completed a self-check, your result band (not your answers) is included with this request.

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A validation specialist will get back to you within one business day.