Warning letters; fines; or even jail time—don’t let these consequences descend on your organization! Prevent bad outcomes of agency observations with a thorough and accurate chromatography data system (CDS) validation. Most of the observations made by regulatory agencies with respect to computerized systems are associated with quality control (QC) systems, specifically CDS. Regulatory bodies audit… Read More

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

The GAMP 5 computer system validation 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:… 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