M
Hi Everyone,
Wondering: Seeing as many (all?) regional regulatory agencies want to see a system procedural document for handling reporting & recalls, and seeing as most of these have explicit guidances posted on the net, is it not sufficient to simply have your SOP reference the appropriate website page?
In composing our SOPs I've included a statement like the following:
...but then I'm not really sure what else to include. Sure, the SOP has responsibility and record keeping requirements specified... but otherwise it's the official guidances that are authoritative. If it ever so happens (heaven forbid!) that we have to do a recall or mandatory adverse event reporting, I know I'll go straight to the appropriate website guidances. As such, I see no reason to essentially copy the guidances' directives when a simple web-link can specified.
Bottom line question: Aside from internal stuff (responsibilities, record keeping etc.), is it sufficient to just reference official guidance documents when composing SOP instructions for recall and reporting procedures?
As always, feedback greatly appreciated!
MM.
Wondering: Seeing as many (all?) regional regulatory agencies want to see a system procedural document for handling reporting & recalls, and seeing as most of these have explicit guidances posted on the net, is it not sufficient to simply have your SOP reference the appropriate website page?
In composing our SOPs I've included a statement like the following:
The ((regional website (link specified))) is the authoritative resource for the most current guidances and forms with respect to medical device reporting and recall. Where there is a discrepancy between the instructions in this SOP, and website guidances, it is the guidances that shall be followed. Reference current guidances here: ((website links)).
Bottom line question: Aside from internal stuff (responsibilities, record keeping etc.), is it sufficient to just reference official guidance documents when composing SOP instructions for recall and reporting procedures?
As always, feedback greatly appreciated!
MM.