Re: Review and Approval of Blank forms and Templates
Sue,
First off, check your internal SOPs (esp. doc control) to ensure that whatever you do, you'll be compliant.
One of my biggest peeves is the draconian control of forms. Some forms, like MDRs do need to be well controlled since there's so much required information. Others, like training forms, should be malleable to allow you to capture information as needed. That's just my opinion and would likely only work for small shops, as you indicate you are (it's what we do and we're also a small shop and also registered to 13485).
One of the things we've done to allow some flexibility is to snapshot the form in a WI and say that the copy in the snapshot OR SIMILAR can be used. When there is required information, we identify it (so it doesn't get tailored out - don't want too much flexibility!).
We also have a controlled area where forms are kept. If a form goes in there (through the controlled process / via restricted access), by default it has been reviewed and approved. Our procedures describe that process (along with the access restrictions). It's a read-only copy and people can pull a soft copy, fill it in, and print it.
I probably wouldn't recommend this for a larger shop but it works for us and it's been defensible to our registrar. We don't do manufacturing so we haven't been audited by the FDA.
The point is to think about what controls you really need, ensure your procedures are set up to define those controls, and the infrastructure is built to implement those controls.