It’s quite easy to mix up the Failure Mode and Effects Analysis (FMEA) from IEC 60812:2018 and the Hazard Traceability Matrix (HTM) in the ISO 14971:2019. Especially since nothing prevents a company from using these terms interchangeably or using different terms...
FDA 21 CFR Part 11 is a regulation that governs how Medical Device, Pharmaceutical, and other FDA-regulated companies should handle their electronic records and electronic signatures. The Life Science Industry is known for a vast number of regulations and various sets...
![21 CFR Part 11 Software Requirements [Explained]](https://www.simplerqms.com/wp-content/uploads/2019/10/21-cfr-part-11-requirements-thumbnail2-1.svg)
