21 CFR Part 11 – Sub Part A – Scope & Implementation
So, you know when you sign stuff electronically, like when you click “I agree” on a website or sign a…
FDA issues Draft guidance for Computer Software Assurance for Production and Quality System Software
Docket No: FDA-2022-D-0795 Issued by: Center for Devices and Radiological Health, Center for Biologics Evaluation and Research The FDA’s draft…