Agile development is one of those buzzwords that you’ve heard a lot if you’ve spent any time at all in the business world. Like Lean Six Sigma, it’s one of those secret handshake-type terms that will have everyone nodding in recognition, even if they’re not really sure what it’s about. But in laboratory informatics—particularly in… Read More

The topic of this blog was occasioned by a recent calendar observation. November 8 is recognized in the United States as National STEM Day (or National STEAM Day). STEM is the acronym for science, technology, engineering, and math; STEAM is its extension when you include the arts. Educators around the country use the occasion to… Read More

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