Possible to have a completely electronic archival system that meets FDA requirements?

[rdavidson]

I work for a medical device company (Class I – II b products) and have been tasked with investigating an ‘electronic’ document retention system, with a view to completely replace the current paper based system in 5 years.
The reason for this is our current 20 year document retention policy, along with massively increased international sales has lead to the need for additional external storage locations. As you all know this can be pricey and things are only going to get worse in the future as the amount of associated documentation (QA/ Reg., etc) increases in direct proportion.
My question is, is this possible? Considering security issues (we aim to store batch records in pdf., format, using layered back-up alternatives and a regular data dump), scanning checks for readability etc., will we ever satisfy European and American prerequisites for inspection of the Quality Management System?
Your thoughts and opinions are greatly appreciated

 

[harry]

Re: Is it possible to have a completely electronic archival system?

Would this suit your purpose?

ISO 19005, Document management – Electronic document file format for long-term preservation – Part 1, Use of PDF 1.4 (PDF/A-1), enables organizations to archive documents electronically in a way that will ensure the preservation of content and visual appearance over an extended period of time. It also allows documents to be retrieved and rendered with a consistent and predictable result in the future, independent of the tools and systems used for creating, storing and rendering the files.

New ISO standard will ensure long life for PDF documents

 

[rdavidson]

Re: Is it possible to have a completely electronic archival system?

Thanks for the quick response Harry!

The link you provided focuses on pdf's and ISO 19005-1:2005. I have ordered the ISO you listed, however it also seems to be linked to a whole raft of other documents which I will not be looking at just yet.

We currently work to ISO 13485:2003 & 9001:2008. I really need to know if it is possible to completely move away from paper storage of batch records and how this would affect us in a federal light. If we could maintain an electronic data retention system, under our current QMS without adding a significant amount of additional inspectable areas, that would be perfect.

 

[rdavidson]

Re: Is it possible to have a completely electronic archival system?

.. Sorry, and just to mention, our biggest concern right now is the American view of this. We already know how tough they can be on Electronic records and signatures. I'm certain they will view this particularly skeptically!!

 

[Randy]

Re: Is it possible to have a completely electronic archival system?

I'm an American and I vote YES, it is possible

 

[rdavidson]

Re: Is it possible to have a completely electronic archival system?

Hi Randy, I'd be glad to hear your view point on this. I don't know your background of field, but do you have any experience of this?

 

[MIREGMGR]

Re: Possible to have a completely electronic archival system that meets FDA requireme

It's straightforward to store records electronically that will satisfy FDA. Just have assured, verified backup with verified restorability; provide appropriate security; and utilize media that do not raise questions as to technological life.

It's not straightforward to do this in the context of a Part 11 compliant data management system, with electronic identification of record creators/modifiers. For that, you need a systems vendor that has engineered that capability.

 

[rdavidson]

Re: Possible to have a completely electronic archival system that meets FDA requireme

Thanks MiRegMgr,

You raise some good questions here such as; how the final sign off of the batch will be handled. From my perspective there seems to be two routes to achieving this, other than our current paper based version:

1. Process the batch as a paper version till sign off, then create the electronic pdf copy and lose the paper copy (most simple version and cheap to implement, but may be difficult to be assured of accurate records, as the pdf., cannot really be considered the original document)

2. Have the entire process electronic, with electronic signatures made to the record at every stage of production (more complaint long term, will need to be run in tandam with current system initially, will involve heavier costs to start, but will greatly reduce increasing storage costs)

Regarding the systems vendor, I would imagine you can tackle mutliple other areas in one hit this way. I have recently been approach by IBS America about their QMS software. There are various others out there, but none really seem to address the batch record itself, rather the management processes i.e. CAPA, Customer complaints etc.

So in essence, I want to know if anyone has actually made this move and if it has stood up to the rigours of inspection?

 

[foxr01 - 2009]

Re: Possible to have a completely electronic archival system that meets FDA requireme

Currently we use Agile DMS software suite. It is totally paperless, even during the approval process. It is also completely FDA compliant.

I really wish we did not have to migrate from it.

 

[MIREGMGR]

Re: Possible to have a completely electronic archival system that meets FDA requireme

I really wish we did not have to migrate from it.

Heh. Well, somebody has to ask: why do you have to migrate from it?

Edit: I just read your other current thread, in which you answer that question. https://elsmar.com/Forums/showthread.php?t=36579