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

The process of software validation ensures that the system fits its intended use and functions as it should. Computer system validation (CSV) for laboratory informatics is essential because regulated businesses must ensure the safety of their products for consumers, and their laboratory informatics systems (LIMS, ELN, CDS) are an integral part of that. Given its… Read More

This blog will discuss some of the regulatory risks involved in using a cloud software service provider, or Software as a Service (SaaS). If you take this route, will you be floating on a cloud or just a clod? A clod is defined as a lump of earth or a stupid person—I leave it to… Read More

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

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