Page Numbering requirement for DHR Report

[Lydia8]

An electronic DHR system is being implemented, which will generate a DHR report to be presented during audits. The report does not currently display page numbers. In my experience, page numbers are a requirement on quality records; otherwise, how would someone know if a page is missing. Is the page numbering requirement existing in a standard somewhere or is it just considered a best practice? I have looked and looked and have not been able to confirm if page numbering is a requirement or not for quality records. I would like to have some evidence if available to support my request that the DHR reports include page numbering.

 

[Randy]

Well, page numbers aren't a requirement unless you make it one. Just as in any other page or document formatting nothing is required.

 

[pkost]

I would be more concerned about the database here...how do you know all of the records are being correctly retrieved? I would hope you have validated your system; your reference to DHR suggests FDA involvement, therefore 21CFR11 probably applies.

I would argue that the document you present is not the record, is just an accessible reference for an auditor; if challenged, give them your database validation and show them the true records which are stored in the database

(Randy is right, there is no specific requirement for page numbers on records, just a requirement to ensure the records are complete and accurate (paraphrasing))

 

[Lydia8]

Thank you for the information. We don't currently have a quality system defined page numbering requirement, just in practice as a way of confirming the completeness of information. True that this report is not a record (though there was some discussion of maintaining it as a record in a hard copy file, which I know is not a good idea). Yes the system is validated. You've answered my question - thanks