FDA's Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation | King & Spalding

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document...

Related Keywords

,International Society For Pharmaceutical Engineering ,Drug Administration Staff ,Computer Software Assurance For Production ,Quality System Software ,Principles Of Software Validation ,Association For The Advancement Of Medical Instrumentation ,Radiological Health ,Software Assurance Activities ,Biologics Evaluation ,Software Assurance ,Quality System ,Current Good Manufacturing Practices ,Veterinary Medicine ,International Society ,Pharmaceutical Engineering ,Risk Based Approach ,Compliant Gxp Computerized ,Medical Instrumentation ,Enterprise Resource Planning ,Automated Process Equipment ,Draft Guidance ,