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

21 CFR Part 11: 20 Years and Counting

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

7 Validation Mistakes You Don’t Know You’re Making

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

New Data Integrity Draft Guidance – Are You Ready?

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