-
Reply to Comparison Table for eQMS Packages
Thanks this is wonderful! I would be interested to see how @quickvault-by-veeva compares?
-
Does anyone know why we can no longer see 510k summaries in the 510k database? I am even trying old ones that I know I have pulled recently and they are all missing…
2 Comments-
I swear I looked at some this morning and now they are not there. Any updates?
-
Not definitively – based on a some folks I have talked to we think its just maintenance things? Fingers crossed – if this was intentional I would hope they would release something about it.
-
-
Holly joined the group
6 months agoeQMS 6 months ago -
Comparison Table for eQMS Packages
FYI: I recently came across this handy comparison table for various eQMS software packages by OpenRegulatory: https://openregulatory.com/qms_software
They also have some more in-depth descriptions for particular eQMS packages on their website. I’m curious for anyone who has direct experience implementing and/or using one of these eQMS if…
-
Aaron updated their profile 6 months ago
-
Aaron changed their profile photo 6 months ago
-
Aaron joined the group
6 months agoeQMS 6 months ago -
Reply to P1/P2 Values RIsk Management
Joe,
Expanding on what Niki wrote, this is an important topic that seems to lead to a lot of confusion and flawed methodology. The P1, P2 probabilities are part of the ISO 14971 risk model but that doesn’t mean they should be explicit columns in a risk table. My recommendation is to make sure that everyone involved in risk assessments…
Niki -
Reply to P1/P2 Values RIsk Management
Great topic!
I think of Pharm as the overall probability (P1 x P2). This is the same as P value – so in the instances where you don’t see P1 and P2 separately, that’s likely the approach. So, if you mitigate P1 to near 0, pharm will be reduced to the same. But they are not equal.
In my experience, technical mitigations can lower P1 – probably…
-
Does anyone want to talk about P1/P2 values as part of the risk management process?
Some FMEAs include them, some do not, and Im looking to expand/broaden my knowledge on how to interpret risk management files that dont specifically call them out.
Note (Per ISO 14971): Risk = Severity x (P1xP2)
I think the explaination is that:
If you can mitigate…
- Load More
