What happens when you fail to comply with CSV?
Computer System Validation (CSV) tests and validates or qualifies regulated GxP computer systems to ensure they do what they are designed to do in a consistent and reproducible manner that is safe, secure, and reliable – and generates the records to prove it.
The resulting CSV reports identify constraints, restrictions, or deviations encountered during the validation effort and state whether a system is functioning for its intended use.
Regulated life sciences companies can’t do business without following CSV regulations; the U.S. Food and Drug Administration (FDA) requires it, as do many other global health authorities.
USDM’s Computer System Validation 101 on-demand webinar is geared toward life sciences professionals new to the industry or pre-commercial companies selecting their IT systems and determining the most efficient way to achieve an audit-ready CSV methodology across their IT systems.
The webinar will address:
Click here to access the on-demand webinar.
Additional CSV Resources
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