SOP unification. Revision No, Revision history

[Cristina14]

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

 

[Richard Regalado]

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!

 

[Cristina14]

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- I have a totally new SOP, which I code under SOP 3 Version 1 (do I mention here that the old SOP 3 was withdrawn and that the new SOP 3 contains totally different information?)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]

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,

 

[Cristina14]

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

This makes sense, actually Thank you for your prompt reply. I have not decided how to proceed yet, but you gave me good food for thought. Not reusing the name of an old SOP sounds less confusing than applying it again.

Have a great start of the week!