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 ‘change control’
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 […]