D
I want to throw out a question to the forum regarding skipping revisions on documentation.
Issue is that this part is currently at Rev A, and on of my collegues checked it out in January to rev it to B. That change is on hold, and not sure when or if it will be resolved.
Another collegue made revisions but also included the changes from A to B but had parts made to C before the document change was approved formerly through our Change Process.
How do other Medical Device companies or other industries handle this. I only skip I,O,Q and it's written in a procedure.
Would a memo to file be sufficient, would that hold up in an FDA audit?
Thanks,
Kevin
Issue is that this part is currently at Rev A, and on of my collegues checked it out in January to rev it to B. That change is on hold, and not sure when or if it will be resolved.
Another collegue made revisions but also included the changes from A to B but had parts made to C before the document change was approved formerly through our Change Process.
How do other Medical Device companies or other industries handle this. I only skip I,O,Q and it's written in a procedure.
Would a memo to file be sufficient, would that hold up in an FDA audit?
Thanks,
Kevin