Posts Tagged ‘21 CFR Part 11’

This is post #4 in a short series about assessing and mitigating risk with regulated software. Over the past few weeks, I’ve discussed the rationale for taking a risk-based approach to this topic, as well as the first couple of steps to take: determining whether a system is regulated and, if so, determining its risk […]

In the previous post in this series, I discussed the process you can use to determine whether a particular IT system is regulated. That post described the first part of a four-part approach to assessing and mitigating risk with regulated IT systems. Today’s post will cover the second part – what to do once you […]

Happy May Day! 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. My Colleagues […]

In the life sciences industry, many of the software systems we use must comply with federal regulations. The purpose of these regulations, such as U.S. FDA 21 CFR Part 11, is to ensure that the data being housed and produced by these software systems is accurate and trustworthy. When the FDA first introduced 21 CFR […]

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 […]

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 […]

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 […]

Let’s tackle a tough one… It’s one thing to put IBM Maximo, an enterprise asset management solution, in the cloud. It’s something completely different to put IBM Maximo in an FDA-compliant cloud!  At Perficient, we don’t do the usual – we cater to the difficult and never been done before, crowd. Our cloud has been serving […]

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

  We’ve done it so many times, we don’t even have to think about it anymore. We’ve got our Siebel CTMS implementation process down pat and it’s marvelously efficient. How do we do it? It starts with our pre-configured version of Oracle’s Siebel Clinical, something we call ASCEND. Combine ASCEND with our hosting services, and […]

  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 […]