JD Supra

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
RAPS

FDA drafts guidance on device production and quality system software assurance

The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical device production. FDA said the draft ...
JD Supra

FDA finalizes computer software assurance guidance for production and quality system software

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
Yahoo Finance

InstantGMP Modernizes Software Validation with FDA Computer Software Assurance-Aligned Approach

CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...
RAPS

Industry seeks clarity, ICH Q9 alignment in FDA’s device production software guidance

Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with medical device production have asked ...
MD&M East

Spotlight on Software

CAPA system Supporting corrective and preventive action (CAPA) practices, a quality system software application for medical device manufacturing has user-friendly and democratic collaboration features ...