FDA CFR 21 part 11

Introducing FDA 21 CFR Part 11 – Industrial Physics

FDA 21 CFR Part 11 is federal drug agency regulation that governs the use of electronic records and electronic signatures.  

This FDA regulation was established to ensure that electronic records can be trusted in the same way that handwritten records, and the pen-on-paper signatures we are more familiar with, are. If you want electronic records validation from the FDA, then you’ll need to meet the requirements of FDA 21 CFR Part 11. 

The temperature compliance aspect of this FDA regulation relates to environmental monitoring that can help ensure that temperature and other digital records are accurate, reliable, and secure. 

What’s included in the FDA 21 CFR Part 11 requirements?

If you want to use any electronic records for regulatory purposes, then they should meet the FDA compliance requirements of FDA 21 CFR Part 11.  

It’s the responsibility of an organization to prove that it complies with the regulations. If it can do so, then the FDA will accept the use of electronic records instead of paper records. This can be done via validation of the system, either by the organization itself or with the help of an electronic system provider. 

There’s just a couple of exceptions – including email-attached scanned paper records.  

FDA 21 CFR Part 11 testing devices

So, how can Industrial Physics improve your FDA 21 CFR Part 11 testing? 

TM Electronics BT Integra Pack: Smart Package Tester 

An easy-to-use bench-top, high-resolution (0.001 psig) test instrument perfect for burst, creep, leak testing and more. This high-resolution (0.001 psig) test instrument has electronic pressure and flow controls and user-friendly ease of operation, making it the perfect addition to any lab or testing space.  

TM Electronics WORKER Integra
Our reliable leak, flow and vacuum decay testing in one integrated process control tool. This easy-to-use testing solution offers repeatable and quantitative results, perfect for a wide range of QA processes. It offers high resolution (as low as 0.0001 psig) leak testing and can be configured to perform pressure or vacuum decay leak testing, flow and occlusion testing on non-porous, flexible or rigid products. 

Need FDA 21 CFR Part 11 testing solutions? Get in touch

If you have any questions about FDA 21 CFR Part 11 and how we can help you with your electronic records validation, then please just get in touch!  

Your global test and measurement partner for FDA 21 CFR Part 11