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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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 main market opportunities lie in adapting FDA-regulated computer system validation methods to align with GAMP®5 Second Edition and CSA, embracing innovative technologies like AI, ML, and ...
The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and ...
CA, UNITED STATES, August 8, 2025 /EINPresswire / -- The latest report from Coherent Market Insights examines the growth prospects of the Computer Software Assurance (CSA) Market from 2025 to 2032.
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...
The market opportunities lie in providing comprehensive training for computer system validation aligning with FDA regulations, offering hands-on practice, agile and waterfall methodologies comparison, ...
Microsoft Corp. yesterday unveiled a new package of benefits that it plans to start offering in September to customers that purchased its controversial Software Assurance agreement to gain upgrade ...
Gerard Holzmann at Bell Labs, Software to detect bugs in networked computers; Charles Howell at Mitre, Benchmarks for software assurance; Charles Simonyi at Intentional Software, Programming tools to ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback