Validation of computerised systems is crucial. The pharmaceutical, biotech, and medical device industries are subject to strict health authority regulations to protect data integrity, product quality, and patient safety. Life Sciences and...
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Estanislao Ferrater Pagani
Automation of Software Development Life Cycle (SDLC)
Automation of Software Development Life Cycle (SDLC) FDA's Center for Devices and Radiological Health (CDRH) intends to publish a new guideline in the Fiscal Year 2021 (FY 2021) [R1]; "Computer Software Assurance (CSA) for Manufacturing,...
