Posts Tagged ‘21 CFR Part 11’

  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. 

  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? 

  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: Is a web-based training system required to be Part 11 compliant? 

  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: Is a web-based quality management system that includes document control and CAPA modules required to be 21 CFR Part 11 compliant? 

  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: When Argus is hosted by Perficient, is it considered an open or closed system for the company that contracted Perficient to host? 

  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 […]

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

  This is the final post on the series dedicated to decoding the mystical “21 CFR Part 11” regulation that governs IT systems in the life sciences industry. How does it feel to have made it all the way through? I hope that, by now, you’re feeling much more comfortable with the purpose, organization, and […]

  Welcome to the final post in the 21 CFR Part 11 “mini-series” on Subpart C – Electronic Signatures, which happens to be the final section in the 21 CFR Part 11 regulation. Let’s polish up our decoder rings one last time for Section 11.300 – Controls for Identification Codes/Passwords. In the table below, the […]

  This post is the second in the 21 CFR Part 11 “mini-series” that is focused on Subpart C – Electronic Signatures. Today, we’ll be using our decoder rings to learn the secrets in Section 11.200 – Electronic Signature Components and Controls. 

  Welcome to the first post in the 21 CFR Part 11 “mini-series” focused on Subpart C – Electronic Signatures. We’ve come a long way since that first post in which we decoded what the name “21 CFR Part 11” even means, haven’t we? We are in the final stretch! Let’s get out our decoder […]

  This is the final post in the 21 CFR Part 11 “mini-series” on Subpart B – Electronic Records. The last Section in Subpart B is 11.70 – Signature/Record Linking. In the table below, the actual language from each regulation is on the left, and my personal interpretation of what that language means is on […]