Archiving eTMF with no in house eTMF solution

[Katie Kelly]

Hi all,
Currently I am working on archiving our studies’ eTMFs, however, we’re a small company and don’t have an internal eTMF solution (eg, Flex, Veeva, etc). How can I archive my eTMF in a way suitable for inspectors to be able to access during an inspection?

We’re looking at some solutions, like Amazon Web Services, but I am hoping I could get some recommendations.

Thanks!
Katie

[James OKeefe]

Hi Katie:

Are the study files coming from an eTMF?

Amazon web services generally is not very user friendly all on its own.

If the study files are coming from some content management system, you can store them in file shares, SharePoint or a host of other options.

I have in the past in this situation used the exported metadata and files to systematically build an excel file (or series of files depending on how big the study file is) to use as an index for easier navigation to the destination file share or SharePoint site.

Iron Mountain also has electronic archiving solution.

Jamie O’Keefe
O’Keefe Life Sciences, LLC
Jamie@okeefelifesciences.com

[Russell Joyce]

Hello Katie.

In response to Jamie’s post, Iron Mountain offers a digital storage solution only not a digital archiving solution. For a bona fide digital archive solution, try Arkivum, Formpipe, or Preservica.

Russell

[Russell Joyce]

Hello Katie

A good starting point is the Health Sciences Records and Archives Association’s “Guide to the Archiving of Electronic Records” (currently in review) and “GCP Archiving Guide”. Both are free to download from the Health Sciences Records and Archives Association website on the Resources / Publications page. I tried posting replies with hyperlinks but with no success: sorry! Hope that helps though.

Russell

[Janna Gonzalez]

Hi Katie,

I agreed with Joyce. Iron Mountain offers secure archiving solutions to store your physical and electronic records, with easy access when needed.

Janna

[Marie-Christine Poisson-Carvajal]

Hi Katie, I also agree with everything said regarding Iron Mountain.

Marie-Christine

[Eldin Rammell]

I am not going to say that any specific vendor is more capable or less capable than another BUT please proceed with caution. There are very specific regulatory requirements relating to archiving. Many of these were written in the age of paper archives but the exact same principles MUST be applied when using a digital archive. In the same way that you would conduct a formal, documented assessment of an offsite paper document storage vendor (and possibly an audit), you must do the same for any technology solution for long-term digital storage of TMF content. You need to have assurance that the organization that you have outsourced the GCP-regulated archiving activity to is able to meet all applicable regulatory requirements.

The GLP guide on archives is a very useful document, in addition to the two HSRAA guides that Russell referred to.

[Kathie Clark]

Taking a step backward, you also need to have a good understanding of your data quality as part of the archiving process. Of course, some organizations do a better job than others in their TMFs, and that becomes obvious when an archive is created.

For example, if you do not have reliable data for every record for its artifact, study, country and site, it will be difficult to create an organized artifact. I have seen exports where site level documents were missing site numbers, and instances where the originating organization has assured the recipient that all information was coded into a file name, which proved not to be true.

So no matter the archive used, you will need to ensure that your data and documents are organized in a manner that will facilitate retrieval and inspection.

Also, quoting from MHRA GCP:

Minimum requirements for an eTMF system should enable appropriate
security to be in place, which would include role-based permissions for activities being undertaken through the use of secure passwords. Accounts should be created and deleted within a formal approval process and in a timely manner. This is analogous to the paper system where the TMF is kept in a secure location, with retricted access.

and from EMA Guidelines:

An external archive providing retention of paper documents or electronic media or electronic storage (e.g. cloud data centre) may be used for archiving of the TMF. When an external archive is used by the sponsor or
nvestigator/institution, they should undertake an assessment of the suitability of the facility prior to use and continue quality assurance measures once the organisation has been contracted. There should be a formal agreement in place between the sponsor/investigator/institution and the external archive. In cases the external archive has several storage locations, the sponsor and/or investigator/institution should ensure they are informed about the actual storage location of their TMF and notified if this changes. The agreement is recommended to include provisions for the situation of
the sponsor or external archive going out of business.

[Janna Gonzalez]

Thank you Everyone.

This information really helps!
Janna Gonzalez

[Russell Joyce]

Hello Katie

A good starting point might be the free-to-download HSRAA “Guide to the Archiving Electronic Records” (currently in revision) and “GCP Archiving Guide”. I hope that helps. Russell

[Patricia Chow]

For company don’t have eTMF and e-archiving solution, if it is to use the SharePoint site for long term e-archiving, what are the steps required to meet 21 CRF part 11 compliance?

[Author]

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