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 ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), announced today that a major healthcare provider in the U.S., ...

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.