Computer Software Assurance for Production and Quality System Software: Draft Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Current Good Manufacturing Practice (CGMP), Digital Health, Postmarket
Published
September 13, 2022
Last updated
September 12, 2022
Description
A draft guidance document on computer software assurance for production and quality system software, covering CGMP and postmarket topics.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)