SOP unification. Revision No, Revision history

#1
Hello,

I am currently reorganising the content of the SOPs of the Pharmacovigilance system. As a result, I have unified some SOPs, therefore document coding has changed. My dilemma is, do I write that the new reviewed SOP is introduced for the first time (hence Version 1) since it has a different code and contains information from multiple SOPs, or do I write Version 2 and mention the codes/titles of the SOPs that were unified.

Thank you!

Regards,
Cristina
 
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Richard Regalado

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#2
Hello Cristina.

I can do it 2 ways.

1. A brand new document, hence version 1. But with a section/preface/footnote containing a short description on how the other SOPs were merged to create the brand new document.

2. I will choose the document that contains the most content of all the other SOPs and will iterate the revision number of that document. In the revision history, I will make mention that this revision is a conglomeration of other SOPs.

Let me know your course of action.
Cheers!
 
#3
1. A brand new document, hence version 1. But with a section/preface/footnote containing a short description on how the other SOPs were merged to create the brand new document.

2. I will choose the document that contains the most content of all the other SOPs and will iterate the revision number of that document. In the revision history, I will make mention that this revision is a conglomeration of other SOPs.

Thank you, Richard.

I believe both suggestions may work for me to some extent. The confusion is because I have the following situation:

- I merge SOP 1, 2, 3 under SOP 1 Version 2 (as you mentioned in 2)
- I merge SOP 4, 5 under SOP 2 Version 1, because of the shifting in the document coding having a note mentioning how the documents fused
- I have a totally new SOP, which I code under SOP 3 Version 1 (do I mention here that the old SOP 3 was withdrawn and that the new SOP 3 contains totally different information?)

Thank you for your reply
 

Richard Regalado

Trusted Information Resource
#4
Thank you, Richard.

I believe both suggestions may work for me to some extent. The confusion is because I have the following situation:

- I merge SOP 1, 2, 3 under SOP 1 Version 2 (as you mentioned in 2)
- I merge SOP 4, 5 under SOP 2 Version 1, because of the shifting in the document coding having a note mentioning how the documents fused
- I have a totally new SOP, which I code under SOP 3 Version 1 (do I mention here that the old SOP 3 was withdrawn and that the new SOP 3 contains totally different information?)

Thank you for your reply
Hello Cristina.

I suggest the following:

- Do not use the name SOP2 since it was already used (now merged into something else). Put a note somewhere that SOP 2 and SOP 3 are merged into SOP 1.
- For the merged SOP 4 and 5, you may use either SOP 4 or SOP 5 as the name
- The new document will be SOP 6.

This is how I will do it. I will not re-use the names/codes of withdrawn, or merged documents.

BUT, this is not in the Standard. So as long as we identify our document, we are good.

Let me know if I made sense, or confused you some more. LOL.

Regards,
 
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