Proper Record/Document Manipulation



I have a little issue I'd like some of your helpful input on.

I came up with a protocol including a checklist and a table to fill out in ink. The document was approved before the procedure began (Rev RA). Now the document is complete and the procedure is finished, so it is now considered a record. However, there are minor additions to the document that were written in with ink, check boxes initialed, and the table filled out in ink.

I'd like to clean this record up and incorporate any written deviation to the typed procedure, and replace the hand written table with a spreadsheet table. I'd also like to add information that was generated in printed sheet form as a result of following the procedure. What is the best way to do this?


Change Agent and Data Storyteller
Super Moderator
Is your checklist contained within the procedure? That's the only way I see the procedure being treated as a "record". A "record" is typically a completed form (or checklist) a nice, simple world.

The documented procedure would could contain information on how to complete the form, who does what, the flow/hand-offs of the form and stuff like that.

Form is one document. Procedure is another. Yet they support each other. Or have I completely misunderstood your situation?


Yes, the checklist is contained in the documented procedure, as it will be a one time procedure.
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