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

For a variety of reasons, software verification and validation has proven to be one of the more challenging and nebulous areas of compliance for companies regulated by FDA. Software, and how it is ...

Every product has defects. Finding them as early in the development process as possible is definitely something to strive for. Building quality into software as it's being developed is far more ...

Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...

SALT LAKE CITY--(BUSINESS WIRE)--MasterControl Inc., a leading global provider of software solutions that enable life science and other regulated companies to deliver life-improving products to more ...

Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Master Validation Plan - The Unwritten Requirements" training has been added to ResearchAndMarkets.com's offering. FDA Warning Letters and recent ...

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 ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...