With more and more pressure being put on research and development units to accelerate the drug development process, many organizations are changing the way they operate. Biopharmaceutical companies are collaborating with academia and CROs in the discovery process and looking at new technology to make their process more efficient. One such technology that, when implemented… 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

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

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

This blog post is part of an on-going series about the LIMS and ELN implementation journey, specifically the Do’s and Don’ts of the implementation planning phase.  Today’s post discusses who should be on your project team from outside the lab.  We’ll take a look at who should be on the team and some of the activities… Read More