Risk is a lens, not a leash. Once teams see what truly threatens patients and processes, the busywork falls away, and quality ...

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 ...

The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and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After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

The use of computer systems in medical device manufacturing has rapidly expanded, creating a growing need for modernized validation approaches. This webinar explores digital computer system validation ...

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 ...

If you have a passion for computers and coding, perhaps you've wondered how to become a software engineer. The BLS reports that software developers, quality assurance analysts, and testers positions ...