Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

QUAKERTOWN, Pa.--(BUSINESS WIRE)--Synergis Software, a global leader in engineering document management and workflow solutions, today announced they will participate in a collaborative, live panel ...

Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...

Life Sciences companies require centralized access and control of GxP documents and CAD drawings to improve quality processes and simplify compliance and system validation for FDA 21-CFR Part 11 and ...

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 ...