Practical working tools
What do you need to do?
Start with the decision in front of you.
AI-guided assessment · GxP & risk
ValLifecycle AI
Turn structured intended-use evidence into a draft GxP applicability decision, a High, Medium or Low risk classification, and a proportional assurance strategy. Incomplete or contradictory evidence is routed to human review.
Medical devices · Software only
Medical-device software classification
Assess software scope, possible harm and preliminary IEC 62304 Class A, B or C. Work through five detailed examples or start your own assessment.
System Assessment
Assess intended use, GxP impact and the proposed validation approach.
Open tool →PlanRequirements & Test Planner
Identify requirements, risk-based testing and the evidence to retain.
Open tool →ReviewDocument & Results Review
Review validation documents, test results and open issues.
Open tool →Worksheets & Templates
Find a working aid for assessment, planning, testing, release, operations or retirement.
For a guided assessment with saved drafts and Word/PDF reports, open the Assurance Assistant.