You know how you implemented that regulated IT system a few years ago, and it was all shiny and new, and then it went through a bunch of change controls and the validation documentation got kind of unwieldy, and now you’re kinda wishing you could start over with a clean slate, but without losing the […]
Posts Tagged ‘CSV’
FDA Guidance On 21 CFR Part 11 And Mobile Tech In Clinical Trials
In June 2017, the United States Food and Drug Administration (FDA) issued a new draft guidance document for public comment: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. You have until August 21, 2017, to share your thoughts and ideas about its content. The […]
My Colleagues Just Solved A Clin Ops Business Problem With…What?
With Appian. Yes, Appian. “I have no idea what that is…” Yes, I can read your mind. Okay, okay, I’m not actually clairvoyant. But I do have a pretty good sense of the industry, and I know that Appian hasn’t become a household name, yet. But, the times they are a-changin’. Appian is a business […]
21 CFR Part 11 Is Complicated Enough, So We Stripped The Legalese
If that title compelled you to open this post, then you know what 21 CFR Part 11 is, and you also know – as my 12-year-old step daughter would say – “the struggle is real.” 21 CFR Part 11 is perhaps the most famous (or infamous!) regulation published by the U.S. Food and Drug Administration […]
Asset Management In Life Sciences
My colleague, Chris Bangma, published a blog post last week that touches on how IBM Maximo, a comprehensive asset management system for managing physical assets, can comply with the FDA’s 21 CFR Part 11 regulation. In particular, he highlights three key areas of the rule that governs the use of electronic records and electronic signatures […]