SOP for Vigilance reporting covering multiple requirements

#1
Hi,

I am working in QA for a medical device start-up company. I am currently working to update our procedure for Vigilance reporting (MDD compliant) to also make it compliant with both FDA and Health Canada requirements.

What I find difficult is not to write the procedure, but how to structure/ compile it, so that the requirements for all countries are part of it without creating any mix-up/confusion.

Thank you. Any idea is very much appreciated!
 
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yodon

Staff member
Super Moderator
#2
It does get convoluted the more countries you add in. What I've found works pretty well is to do a flowchart then supplement the "actions" with any details in the text as needed. There are a number of common decision points along the path. Timeframes, though, are not necessarily consistent. I've also seen attempts at tables. If you have more than 3 countries, though, that approach gets a bit ugly in terms of readability.

I've yet to see a great way to capture / present this information. Maybe someone will jump in with a brilliant approach.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
A flowchart sounds like a good idea, though I never tried to build one for a lot of different regulatory domains. I think that the main challenge would be to stay on top of all regulatory updates and integrate them into the chart without too much hassle.
 
#4
Thank you for both responses! I was considering the table approach at first, but then I thought it might be better to break them by country within the procedure. This seems to be the most convenient specially as there is a possibility that in the future we will need to add requirements for other countries as well, so that would probably spare us of some clutter.
 
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