The Origins of Computer System Validation

The Origins of Computer System Validation

What does Silly Putty have in common with Computer System Validation (CSV)? A thought-provoking question, but one that points out how much we don’t know about the origins of many things we use daily. Silly Putty and CSV are both examples of innovation driven by military applications that are now part of our daily lives…. Read More

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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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