Free Checklist
2025 Validation Readiness Checklist: A Comprehensive Cross-Industry Guide
This checklist helps teams confirm they are ready to start validation. It defines readiness as the state where all prerequisites and entry criteria are met.
It is written for QA, Regulatory Affairs, Project Management, IT and Operations professionals. Use it to benchmark current practice, align with regulatory expectations and stay audit-ready.
What’s inside
- Validation readiness fundamentals and where readiness sits in the validation lifecycle
- Prerequisites and entry criteria: planning, documentation, resources, technical preparation and risk management
- The role of Quality Risk Management in readiness
- How readiness applies to software, manufacturing, pharmaceuticals, medical devices, data systems and AI
- The core 2025 checklist: specific, verifiable criteria grouped by category
- How criteria change for prospective, concurrent and retrospective validation and revalidation
- Key standards and 2025 trends, including AI and Computer Software Assurance (CSA)
- Best practices for putting the checklist to work in your organization