Tag Archive for Risk Analysis

Risk Assessment: When is One Necessary?

Q: Can you tell me when I need to perform a risk assessment?A:  I believe a risk assessment is always necessary. For everything you produce, you should have a product risk assessment that provides you with an understanding of how your product design may impact patients…


When to Open a CAPA

Q: How do I perform a risk assessment of my processes to determine when to open a CAPA project? I’ve seen various approaches, including the use of FMEAs, process monitoring coupled with “X” standard deviations of unfavorable change, three complaints of…


Change Control for Software Updates

Q: We’re performing a Medra library update to our drug safety software and also considering changing a specification in our LIMS static data. In a regulated environment, do these functions require change control, or do you consider them merely maintenance issues?…