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

Does Substance Matter? – A 2017 Lab Informatics Review

2017 has been characterized by daily chaos, uncertainty and loud voices shouting at one another from polarized positions.  What will 2018 bring?  Your guess is as good as ours on that, but that’s not the point of this blog… In laboratory informatics, we ultimately must work within the constraints of the scientific method.  Therefore, substance… Read More

Pittcon 2017 – Where Did Everybody Go?

While reflecting on this past Pittcon, we at CSols were somewhat dismayed to realize that many of us have been attending Pittcon for well over 30 years.  For most, our attendance at Pittcon started while in graduate school when we were afforded an opportunity to present a technical paper on our “cutting edge” research.  In… Read More

Onshore vs Offshore Informatics Consulting

Successfully selecting, implementing, enhancing, and integrating laboratory informatics systems such as LIMS, ELN, SDMS, CDS, etc. requires specialty knowledge, skill sets, and hands-on experience.  With these requirements, it is not unusual that a laboratory organization will not have enough appropriate internal resources to staff laboratory informatics projects.  Additionally, hiring permanent personnel for lab informatics projects… Read More

Biopharma QC LIMS: Extinction or Evolution

For several years now, the future of Quality Control Labs and the Quality Control LIMS that automates and manages them has been a topic of debate.  Some have predicted the imminent demise of both.  Others have postulated that while QC Labs/LIMS will continue to exist, they will do so only by adapting.  Adaptation here means… Read More