Change Control, Configuration Management & Periodic Evaluation
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In This E-Book You Will Learn
How to categorize and control system changes from standard updates to emergency fixes while maintaining your validated state throughout
How Annex 11, Annex 15, MHRA, and FDA CSA define change control obligations including impact assessment, regression testing, and periodic evaluation cadence
How to build a complete test strategy library aligned to GxP risk: functional, data integrity, security, interface, and business continuity testing
How to automate regression testing and evidence capture without losing audit defensibility
Trusted By Industry Leaders
Change & Test Strategy Guide
Keep Your Validated State Through Every Change, Every Audit
Maintaining a validated state is not a one-time activity, it requires structured change control, risk-proportionate regression testing, and periodic evaluation that covers incidents, deviations, security posture, and upgrade history. This chapter provides a practical framework for both: a change control model with four defined paths, and a test strategy catalog that tells you exactly what to test, how to automate it, and what evidence format satisfies modern regulators.
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An indispensable tool for managing the software validation life cycle. Comprehensive and structured, ensuring compliance throughout every phase.
Principal Validation Consultant
30+ Years Experience
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