Over the past several weeks, I’ve published a series of posts that talk about how to assess and mitigate risk with your regulated IT systems. The FDA recommends using a risk-based approach to accomplish this feat, and we agree, so we laid out a four-part approach for you: Assess a system for its regulated status […]
Posts Tagged ‘21 CFR’
How To Mitigate Risk When Changing A Regulated System
A few weeks back, I described how to determine the risk level of a proposed change to a regulated IT system. I also talked about how the system risk level (SRL) and change risk level (CRL) work together to determine the level of rigor required to implement a proposed change without disrupting its validated state. […]
How To Assess The Risk Level Of A Change To A Regulated System
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 […]
How To Determine The Risk Level Of A Regulated IT System
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 […]
How To Assess And Mitigate Risk With Your Regulated IT Systems
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 […]