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Electronic archiving - true copy

Even in 2023, the digitization is not fully implemented in every company. What is the result of this? You still need to maintain expensive, fireproof archival vaults with keeping inventory of the documents, and you also need to have people responsible keeping those vaults in order. Or worse, if you don't have enough place, you have to outsource the storing, limiting your ability more to retrieve document when you need them.


How can you get rid of this situation? Let's check MHRA data integrity guide, if it can help us (all citations will be from section 6.11.2).


'6.11.2. True copy

A copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.'


OK, this is helpful. Although the true copy of electronic data can be tricky due to all metadata, containing audit trail, if you scan the paper document, you can easily verify the generated pdf is identical to the original.

Let's spell it out here: the pdf is going to be an electronic record, under the requirements of EU GMP Annex 11 and 21 CFR Part 11. In other words, you need to care about backup, user restriction, etc. Maybe the best way is to store the pdf's in a database instead of a simple FTP.


What else do we need?


'Consideration should be given to the dynamic functionality of a ‘true copy’ throughout the retention period'

This can be relatively easy: you can use OCR (Optical Character Recognition) when you scan, with this feature you gain more dynamics to your document than the original.

You can also use tags for your document, to help the easier searches later.


And how does that pdf become a true copy?


If we check the definition from MHRA, we need a verification. In other words, the only thing we need is an electronic signature from a user who will declare that the pdf is identical to the paper document. In reality, that signature will mean that the person checked all pages of the pdf if the scanning was done in a satisfiable quality.


One last thing to think through: what should we do with the paper-base documentation after archiving it electronically?


'Organisations should consider any risk associated with the destruction of original records.'


So beside the fact you can destroy your paper-based document, you can choose to do it in e.g., annual campaigns, or you can also build in the e-archiving in your processes. As an example, after you filled out your checklist to release a batch, you do the release, the next step can be to do the e-archiving, and last one is to destroy the paper.



To sum up, I don't think this solution is too complex, and you can spare a lot of activities related to archiving in the future.


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