Posts Tagged ‘validation’

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 […]

If you’re in the life sciences industry and are considering IBM Maximo for regulated uses, we’ve got good news: it’s capable of 21 CFR Part 11 compliance! And, if you’re not familiar with 21 CFR Part 11, Perficient has the ultimate guide to help you. Here are the three key areas of the regulation that govern […]

The other day, I was on a business development call in which the Appian platform was discussed. Appian happens to be a “Leader” in Gartner’s 2015 Magic Quadrant for Intelligent Business Process Management Suites. Not too shabby. The presenter talked about Perficient’s successes with Appian in financial services and healthcare, but when I heard him […]

  Now that March 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 February – they’re ranked in order of popularity, with number one being the most viewed piece. 

  As a big fan of efficiency, it pains me that most of us in life sciences still execute validation testing with pen and paper, present company included. All of those poor trees. All of that hand-cramping. All of that scanning. All of those migraine-inducing QA reviews in which we’re squeezing scanned test cases into […]

  On December 17, 2015, the FDA issued a warning letter to Sun Pharmaceuticals Industries Ltd. in Gujarat, India. Sun Pharma’s website boasts that it is the “World’s 5th Largest Specialty Generic Pharmaceutical Company” with over 2,000 products in more than 150 markets across the globe. When an organization that large winds up with a […]

  Over the past few months, the life sciences practice has produced several free resources related to the 21 CFR Part 11 regulation that governs electronic records and electronic signatures. To make it easy for our industry colleagues to find those resources, we decided to create a single blog post that links to all of […]

  Several months ago 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: Regarding “the organization” that needs to inform the FDA of the intended use of electronic signatures, in a CRO/Sponsor relationship, who is responsible: the […]

  Last November, I wrote about the new release of Oracle Clinical, Remote Data Capture (RDC), and Thesaurus Management System (TMS), version 5.1. As many companies continue to run these “tried-and-true” clinical data management and EDC systems, the enhancements were quite welcome. Since then, our data management team has been developing a complete Validation Suite […]

  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: In one of the initial slides, you mentioned that documents attached to emails do not fall under 21 CFR Part 11. Could […]

  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: Does 21 CFR 11 apply to a CTMS (clinical trial management system), CDMS (clinical data management system), EMR (electronic medical record), or […]

  We recently discussed customizing and configuring clinical trial software that is hosted in the cloud. For the final post in our “cloud fact or fiction” blog series, we’ll discuss the hot topic of validation.