The FDA's New QMSR Is Live. Here's What It Means for Your Equipment Validation
As of February 2, 2026, the FDA's new Quality Management System Regulation is in effect. If you work in pharma, biotech, or blood plasma and rely on validated equipment to store high-value products, this change affects you.
Here's what happened and what you should be paying attention to.
What Changed
For nearly 30 years, the FDA's Quality System Regulation (the old 21 CFR Part 820) governed how manufacturers of medical devices and related equipment maintained quality systems. It worked, but it was a uniquely American framework. Meanwhile, the rest of the world coalesced around an international standard called ISO 13485:2016.
The new QMSR essentially retires the old QSR and replaces it with ISO 13485, incorporated by reference. With this change, the FDA is aligning the U.S. with the international standard that regulatory bodies in Europe, Canada, Japan, and elsewhere already use.
In practice, most of the written content in Part 820 has been stripped out and replaced with references to ISO 13485. The regulation went from 15 sub-parts down to two. But that simplicity on paper doesn't mean the expectations are simple.
Why This Matters for Your Cold Storage Operations
If you manage ultra-low temperature freezers that store blood plasma, biologics, vaccines, or research samples, validation is already part of your world. IQ, OQ, and PQ protocols are how you prove that your equipment was installed correctly, operates within spec, and performs consistently.
The QMSR doesn't eliminate any of that. But it changes the framework your validation documentation needs to fit into.
The biggest shift is the emphasis on risk-based thinking. Under the old QSR, the word "risk" appeared exactly once in the entire regulation. In ISO 13485, it appears over 25 times. The new regulation requires risk to be integrated throughout the entire quality management system. That means your validation protocols for a plasma freezer aren't just about proving the unit holds temperature. They need to connect to a broader risk assessment that considers what happens if it doesn't, how that risk is monitored, and how your corrective actions are documented.
The Inspection Landscape Just Changed Too
Here's a detail that catches people off guard: under the old QSR, the FDA couldn't inspect your internal audit reports, management review records, or supplier audit reports. That exemption is now gone.
The QMSR gives inspectors the authority to review those documents. If a third-party vendor performed your IQ/OQ/PQ validation, the transparency of that work is now under more scrutiny. The quality of the documentation matters more than ever, and "we passed" isn't the same as "here's the documented evidence showing exactly how and why we passed."
The FDA has also retired its old Quality System Inspection Technique (QSIT) as of the February 2 effective date. A replacement inspection methodology is expected, but the details are still being finalized. What we do know is that inspections will continue, and the bar for documentation quality isn't going down.
What This Means for Equipment Validation Specifically
If you're working with a partner to validate your ULT systems, the core process doesn't change. You're still proving three things: that the equipment was installed right (IQ), that it functions the way it should (OQ), and that it performs reliably under the conditions you actually use it in (PQ).
What changes is how that proof needs to be documented. Under the QMSR, it's not enough to show that your freezer passed a test. You need to show why that test was the right one to run, what risks it was designed to address, and how the results connect back to the rest of your quality system. The emphasis has moved from "did it work" to "can you show your reasoning."
The biggest practical shift is traceability. The QMSR, through ISO 13485, explicitly requires documented traceability between design inputs, outputs, verification testing, and validation. That used to be a best practice. Now it's a requirement. Every step in the validation process needs to connect to the one before it in a way an inspector can follow from start to finish.
Don't Panic, But Don't Wait Either
The FDA has said repeatedly that the requirements under the QMSR are "substantially similar" to the old QSR. If your validation programs were thorough before, you're not starting from scratch. But "substantially similar" isn't "identical," and the areas where the two diverge tend to involve documentation structure, risk management integration, and the language used in your quality records.
If your validation documentation still references the old QSR terminology and frameworks, now is the time to review it. Updating the language to align with ISO 13485 terminology signals to inspectors that your organization is current and intentional about compliance.
Where NWR Fits In
We've been performing IQ, OQ, and PQ validation on ultra-low temperature systems for over 20 years, primarily in the blood plasma sector. Our protocols have always been built to meet or exceed FDA and international regulatory guidelines.
As the QMSR takes effect, we're here to help our clients navigate the documentation and process adjustments that come with this transition. Whether that's a full validation of a new system or a review of existing protocols to ensure alignment with the current regulatory framework, it's the kind of work we do every day.
If you have questions about how this affects your operation, reach out.