Working notes on Dynamics 365, computer system validation, and the operating realities of regulated Life Sciences companies — written by the people who do the work.
How Dynamics 365's 2026 release wave and FDA's CSA guidance combine to make a continuously validated ERP possible — and why that changes the timeline math for emerging Life Sciences companies.
A validation pack is not a methodology. These five artifacts carry an inspection — and each one fails in a predictable place.
After fourteen years, the EU's rulebook for computerised systems is being rewritten — and it grew from five pages to nineteen. If you are buying or validating an ERP, the draft already tells you where to build.
CSA didn't lower the bar. It moved the effort to where the risk is. A year on, the most common misreading is still costing regulated companies time and defensibility.
The rules for AI in GMP are still being written. The durable principle is already clear — and Microsoft's ERP platforms, Business Central and the finance and operations apps, now have the controls to enforce it. Here is where we stand.