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

You can’t escape the knowledge that the world is currently in the midst of a global pandemic of COVID-19, the disease caused by the novel SARS-CoV-2 strain of coronavirus.  Tracking and slowing the spread of disease have been on everyone’s mind for much of the year. We know that this will be difficult to do… Read More

Computer System Validation is an essential and complicated task for regulated computer systems.  It can be challenging, which is why learning from each validation performed can help make all future validations easier, with fewer deviations.  This learned experience can only be obtained from executing a validation and not just learning how to perform one. Each… Read More

When deciding to make the purchase of a computerized system for your lab, it is important to know which areas require compliance. Testing of a laboratory informatics system (LIMS, ELN, CDS, SDMS), that is required to be compliant, is mandatory. Vendors supply their systems with appropriate validation documentation that is, in part, a basic outline… Read More

Validation Plan? 🗸Test Scripts? 🗸Testers and Approvers? 🗸 Your Computer System Validation (CSV) project is underway. Or is it? The Items checked above, in addition to a few other documents, are key to the success of your CSV project.  However, within those items, there are crucial details that can easily be overlooked or oversimplified opening your organization to… Read More