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organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, ...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, Nov. 10, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation Training Boot Camp?: Master FDA, EMA, and GAMP 5 Computer System Validation Requirements (Dec 9th - Dec 11th, 2025)" training ...

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 ...

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.

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 ...