Risk-based Assessments in Laboratories

Risk Assessment

The GAMP 5 guidance on the risk-based approach to GxP computerized systems laid out a framework for validating laboratory informatics systems (among other systems). This framework has been the gold standard for risk-based assessments since its publication in 2008. The International Society for Pharmaceutical Engineering (ISPE) published an updated Good Practice Guide: A Risk-Based Approach… Read More

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What Is IQ OQ PQ in Software Validation

IQ OQ PQ

If you work in a business regulated by a government agency, once you’ve implemented or upgraded your LIMS, ELN, or CDS, you need to validate it for your intended use. One part of the validation process that often seems confusing to our clients is the IQ, OQ, PQ testing. This blog will demystify these validation… Read More

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CSV to CSA: A Paradigm Shift in Computerized Systems’ Approaches – or not?

Blog Post: "CSV to CSA: A Paradigm Shift in Computerized Systems’ Approaches – or not?"

In this blog, Charlie examines the Computer System Assurance initiative from the U.S. Food and Drug Administration (FDA) against the long-established CSV approach. For more blog information from Waters experts, click here: blog.waters.com. No more validation. CSV is a thing of the past. These are just some of the attention-grabbing headlines I’ve seen in various… Read More

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