Where to find a pagination requirement as "Page x of y"?

[Ajit Basrur]

There are so many practices followed for which a direct relation to any requirement may not be found. For example, in medical devices, we follow a pagination schema for all documents as "Page x of y".

Does anyone know where this requirement is in any FDA or ISO?
.

 

[Tidge]

That schema is a common implementation to help satisfy document control (review, retention) procedures, specifically to allow approvers and reviewers of documents to know that a document is complete.

 

[Ed Panek]

I have also seen in Military documents a "this page left blank intentionally" for blank pages. just to verify its not a mistake.

 

[blackholequasar]

Although it is used throughout industry, I don't recall any specific requirement set in place via ISO or FDA.

 

[John Broomfield]

Perhaps it came from an auditor asking “how do you know the document is complete?”

 

[Ajit Basrur]

I came across this European Medicines Agency (EMA) document that have added another four items to already practiced ALCOA terms:

Complete, Consistent, Enduring and Available (when needed)

Reflection paper on expectations for electronic source data and data transcribed to elecronic data collection tools in clinical trials (europa.eu)

 

[LUFAN]

I don't know of a specific requirement, but I tend to write this into my Doc procedure in a "Good Documentation Practice" section.

 

[Enternationalist]

This is just one way to implement a check that your records are complete and undamaged, etc. For digital documents, I've seen it done by taking a SHA hash to check you've got the right thing.