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After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome ...

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 ...