- The FDA's Computer Software Assurance guidance, finalized September 2025 and updated in early 2026, is a risk-based approach that focuses heavy testing on high-risk features and allows lighter methods elsewhere.
- Validation burden follows the regulated activity, so quality management living inside your ERP pulls the whole ERP into validation.
- Keeping quality management in a separate purpose-built system limits validation to just that system, and some vendors include validation documentation in their subscription.
- Business Central's native quality tools aren't FDA-compliant on their own, so 21 CFR Part 11 electronic signatures require a life-sciences add-on.
Back in April, the owner of a small FDA-regulated medical-device company told us the FDA had "loosened their restrictions on what's required to be validated." He's right, and a smart architecture decision can turn that change into real savings on an ERP project.
What changed, in plain terms
For regulated manufacturers, any system that touches product quality or traceability has to be validated, meaning you document that it does what it's supposed to, from requirement through testing. That work, historically called computer system validation (CSV), can be the single most expensive line item in an ERP project.
In September 2025, the FDA finalized new guidance called Computer Software Assurance (CSA), and updated it in early 2026. CSA is a risk-based approach: it focuses heavy, scripted testing on the high-risk features that actually affect patient safety and product quality, and allows lighter methods for everything else. It officially replaced the older validation section it superseded, and the stated goal is to cut unnecessary documentation.
The architecture decision that saves the most
Here's the move that matters, and it's the one our distributor put his finger on. The validation burden follows the regulated activity. If your quality management lives inside your ERP, the whole ERP gets pulled into validation. If you keep quality management in a separate, purpose-built system, you can limit validation to just that system.
Keep the regulated activity walled off. Run your ERP for the ordinary business, run a dedicated quality management system for the regulated part, and you shrink what has to be validated. Some quality-system vendors even include validation documentation as part of their subscription, which can take that work off your plate entirely.
Where Business Central fits
Business Central, Microsoft's cloud ERP, has light native quality tools that aren't built to FDA standards on their own. For regulated needs, like compliant electronic signatures under 21 CFR Part 11 (the FDA rule for electronic records), you add an industry add-on built for life sciences. That's normal: the platform handles the business, and a specialist add-on handles the compliance-specific pieces.
The honest division of labor
One last point worth being clear about. An IT partner can assemble clean validation documentation and architect the systems so your scope stays small. But what actually has to be validated, and what's exempt, is a regulatory and legal call. The right team is your quality and compliance people deciding the "what," and your IT partner delivering the "how."
If you're a regulated manufacturer scoping an ERP and worried validation will swallow the budget, the design choices you make up front are where the savings are. We're glad to think through the architecture with you. Let's talk it through.