Analysis for people who execute validation programs — where expectations are shifting, where inspections concentrate, and what actually works on the floor.
Computerized Systems
Computer software assurance is not a rebrand of computer system validation. A practical look at what changes in risk determination, testing and evidence — and what does not.
8 min read
Data Integrity
Data integrity findings cluster around a small number of predictable failure patterns. Recognizing them early is faster than assessing every system from scratch.
7 min read
CQV
Integrated commissioning and qualification only saves time when the commissioning evidence is planned, controlled and reviewed to a qualification standard from day one.
6 min read
AI
A practical framework for evaluating AI and machine learning applications in regulated operations: intended use, consequence, oversight, monitoring and change control.
9 min read
Process
Continued process verification is the stage most programs under-resource. What a working Stage 3 program actually contains, and how it feeds back into the control strategy.
6 min read
Computerized Systems
Cloud and multi-tenant systems shift control to the supplier. How to build a defensible assurance approach around continuous vendor updates and shared infrastructure.
7 min read
