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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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 ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and ...

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

FDA divides its planned guidelines into an A-list featuring prioritized documents and a B-list of texts it intends to publish. This year, the A-list is topped by the final guidance on clinical ...

A curated partner ecosystem uniting methodology, technology, and managed services to move life sciences from compliance ...

Dublin, Jan. 07, 2026 (GLOBE NEWSWIRE) -- The "CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See (Jan 13, 2026)" training has been added to ResearchAndMarkets.com's ...

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...

(MENAFN- GlobeNewsWire - Nasdaq) This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with ...