Your manufacturing execution system (MES) can be a valuable part of your organization’s data management plan—if you are using it to its full potential. Is your MES integrated with your laboratory information management system (LIMS) or your enterprise resource planning (ERP) software? If you are operating in the life sciences industry, has your MES been… Read More

If you operate computer software, at some point you may need to consider some aspect of validation. As an end user of any software, you benefit from the validation and testing that software underwent before it got to you. Validation of systems or instruments assures all parties that the object of the validation will function… Read More

Opinions expressed by CSols Inc. contributors are their own. In life sciences, including pharmaceuticals, biotechnology, and medical technology, when considering the impact of good practices (GxP) activities and their supporting records and data, the most important risk is the risk to the patient. When we move away from a patient-centric approach, our efforts may no… Read More

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