Tag Archive for Risk Analysis

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?…