I am not sure if JAMA review center will be able to handle the FMEA or PHA review with particular ISO standard format. I assume we will probably need to create template and export it for review. Let us see how other JAMA experts do.
Hi Simon and Bob,
We do not have specific instructions or best practice articles on how to set up FMEA's. I did find a couple of resources on the community that might be useful. I welcome you to check them out for conversation and some context:
My other suggestion is to reach out to your Account Manager and ask about engaging services to have a consultant go over implementation for your organization.
Lastly, Simon, to answer your question about Figure 5 found in the "Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971" document, they are using the Coverage Explorer. I was able to view all of my selected fields on my own hosted instance. What version of Jama are you using? Can you also take a screenshot of the behavior you see? This will help me troubleshoot this for you.
Thank you both.
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