Ask the Consultant: Computer System Validation Advice

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

Ease Concerns About DSHEA Updates in Your Nutraceutical Lab With a LIMS

The U.S. Food and Drug Administration (FDA) recently announced plans to update the Dietary Supplement Health and Education Act of 1994 (DSHEA). The potential DSHEA changes have prompted concerns about the business impacts of additional regulatory rigor. To be ahead of the competition when changes occur, nutraceutical manufacturers should consider implementing a Laboratory Information Management… Read More

5 Things to Document When Justifying a LIMS or ELN

As clients go through the process of getting approval for laboratory informatics purchases, CSols experts often field questions like, “How much does a LIMS cost?” or “Is an ELN worth the investment?” or “What is the ROI for LIMS?” The answer to these questions will change for every client based on their business goals and… Read More