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

“An ounce of prevention is worth more than a pound of cure” ~Benjamin Franklin Although this quote is generally attributed to human health issues, it can also apply when one is considering the “health” of your laboratory computer systems and business processes.  Just as taking care of yourself (i.e. eating healthy, exercising, and getting sufficient… Read More

20 years ago, as a response to the pharmaceutical and life science industries wanting to increase the use of computer systems in the lab, the FDA released 21 CFR Part 11.  The ruling on using electronic records and signatures in place of their hard copy counterparts has since impacted not only how we collect, analyze,… 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

The move to electronic data collection, analysis, storage, and reporting continues to grow in the pharmaceutical and life science industries.  Software is becoming more robust with features and functionality enabling labs to become more paperless.  But, regardless of where you are on your quest to reduce the use of paper in your lab, the responsibility… Read More