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 ...

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Continuous compliance: Rather than preparing for audits, agents continuously monitor validation completeness, test coverage, ...

Dublin, Nov. 10, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation Training Boot Camp?: Master FDA, EMA, and GAMP 5 Computer System Validation Requirements (Dec 9th - Dec 11th, 2025)" training ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

With car companies adding more cameras, digital display screens, active safety systems and other technology to their vehicles with each passing year, they are starting to rely more and more on ...

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, ...

Computer system validation (CSV) has been the source of considerable drag on device makers’ efforts to realize value derived from investments in the company’s technology base, but this long-standing ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...