Complying with eTMF archiving and data management regulations is a challenge
Traditional storage practices do not guarantee compliance
Clinical trial sponsors are required to retain the eTMF for at least 25 years.
Effective digital archiving & preservation is required to ensure;
- Data is not corrupted or lost
- Information can be easily found
- Files do not become obsolete
- Secure access can be granted to inspectors
- A full audit trail is recorded.
And importantly, any solution must meet rigorous quality standards (QMS/CSV/GxP).
A fully validated eTMF preservation solution
Backed by a robust QMS
Arkivum provides a fully validated digital archiving and preservation solution. Easy to setup, our solution provides the confidence and protection our regulated customers require, regardless of where they are in the clinical trial process.
We ensure that your eTMF is preserved, accessible and usable for the whole retention period and guarantee you are inspection ready.
We regularly deliver validated (CSV) releases of our software and place a great importance on our QMS and related SOPs. This means we are confident in our quality processes and fully welcome customer audits.
A guide to effective eTMF archiving and preservation
Recently published eBook provides an introduction to ensuring your eTMF is inspection ready
Arkivum recently published a new eBook on the basics of eTMF archiving and preservation.
This new guide provides a detailed overview of what sponsors should consider when planning for the long-term management of the eTMF, including;
- How preservation differs to a backup
- What eTMF regulations you need to be aware of
- When to start planning your archiving strategy.
Download this free report today.
Related eTMF archiving articles
08 Apr, 2020
eTMF archiving myths, misconceptions, and half-truths – here’s what you need to know
All pharmaceutical companies have a regulatory requirement to keep eTMF data for the long term – last year’s European Medicines Agency’s (EMA) guidance stipulating storage for over…
01 Dec, 2020
Managing your eTMF archive: an effective approach to digital preservation
Last year we published a post on good electronic Trial Master File (or eTMF) archiving practices and what you needed to know. Given the time that’s passed,…
20 Oct, 2020
The value in archiving eTMFs beyond compliance requirements
All pharmaceutical companies are required to keep key GxP records (eTMF data, clinical study reports, lab notes etc) for the long term. EMA guidelines which came into…