As life sciences, pharmaceutical, biotech, and medical device organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, ...
Dublin, Aug. 25, 2025 (GLOBE NEWSWIRE) -- The "Digital Validation Demystified - GAMP? 5 2.0 and CSA Integration" training has been added to ResearchAndMarkets.com's offering. This course equips you ...
In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality ...
A new final guidance document released by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) puts into place voluntary guidelines for blood establishments ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
1.Why does FDA require validation of spreadsheets and databases? To put it simply, the purpose of validating any software or computerized system is to establish trust in the data or electronic record.
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, ...
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