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Posts Tagged ‘Computer System Validation’

A Compliant Do-Over For Regulated IT Systems

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 […]

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In June 2017, the United States Food and Drug Administration (FDA) issued a new draft guidance document for public comment: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.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 […]

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 […]

How Are GAMP 5 And 21 CFR Part 11 Related, If At All?

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: What about GAMP 5? How does it fit into 21 CFR? How to combine both? 

Top 5 Life Sciences Blog Posts From April 2015

  Now that May is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in April – they’re ranked in order of popularity, with number one being the most viewed piece. 

21 CFR Part 11: There’s Still Time To Get Your Decoder Ring

  Inspired by our blog series from earlier this year, the head of our Computer System Validation team will be delivering a webinar on Thursday, April 23, 2015 aimed at “decoding” the 21 CFR Part 11 regulation. In the webinar, validation guru Sally Miranker will be reviewing the regulation point by point, offering up Perficient’s interpretation […]

The Elephant In The (Server) Room

  Server Virtualization: An amazingly helpful technological advancement that has left computer system validation (CSV) teams everywhere scratching their heads. Why? CSV calls for proof that the servers used for regulated computer systems meet or exceed the minimum hardware requirements for those systems. This is known as “hardware qualification” or “HQ.” But when the hardware […]