InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its software development and validation practices ...

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

After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

"Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities" training has been added to ResearchAndMarkets.com's offering.

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 ...

The FDA has intensified its focus on data integrity in computer system validation during inspections and audits, emphasizing the critical role of compliance in systems utilized across regulated ...