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 […]
We’ve been getting a lot of requests, lately, to help companies decommission their old GxP systems. The systems were once validated and still contain GxP data that might someday need to be reviewed or analyzed, but they’re no longer being actively used. They’re just sitting there, taking up server space, undergoing basic IT maintenance, […]
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 […]
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?
As a company who implements and enhances clinical trial management systems (CTMS), a question we hear a lot is, “Do we need to validate our CTMS?” And, to be honest, it’s one we continue to debate internally. Why is the answer not black and white? Well, our internal debate always works its way back to […]
It’s probably a safe assumption that your organization made the switch to an electronic document management system (e.g., SharePoint, Office 365, Documentum, Alfresco, NextDocs, eDOCs DM) some time ago. Take a few minutes and think back on the underlying reasons for that investment. I’m sure the list you came up with includes things like keeping […]