Learnaboutgmp Community

Document management

Any advice on the following would be welcome!

I have seen a situation whereby an electronic template (a Word document) is to be used in two stages. At stage 1 it is either printed out blank and hand completed up to a defined point, or it is electronically completed to the same defined point and then printed out.

At this point it is then approved by ink signature.

Then at stage 2 further information is added, and the new information approved. For the hand written document I see no problems particularly (the procedure is clear about what is being approved at each stage and what the approval means).

However, I am uncertain about whether this is really appropriate for the electronically completed document. It is clear that the part-completed electronic document is retained, and further information is added for the second stage approval. I think this makes it an electronic record, despite it being the paper copy which is approved, used and retained in the archive. There is a clear opportunity for there to be a difference between the approved copy at stage 1, and the copy which goes for the second stage of approval at stage 2 - even though the second approval is only partly related to the first (the first approval is that the information is correct, the second approval is that the work has been done).

What are the thoughts of others please?

Thanks

It’s kind of a tricky question.

When the first approval is made for a document that has been written up electronically how is it possible for stage 2 of the document to be written up electronically aswell if stage 1 has a handwritten signature.

Why dont you separate this process into two different documents linked by a unique number and avoid all this confusion.

Let me know your thoughts