Lab Informatics CSV – Not a Commodity
If your laboratory is operating in a regulated environment, then you are faced with the challenge of ensuring your operations and systems are ready to withstand the scrutiny of a regulatory audit, or else face the consequences. But depending on your industry and your environment, different regulations may apply. For laboratories using computerized systems to support manufacturing operations in the pharmaceutical industry, you will be concerned with GMP, GLP, 21CFR11, and Computer Systems Validation (CSV). In this environment your laboratory informatics systems (LIMS, CDS, ELN, SDMS, instrument systems, etc.) are expected to be validated for intended use.
However, all of this should… [ Read More ]
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CSols, Inc.
Informatics Insider
www.csolsinc.com/blog
