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.
Only 31% of sponsors think they adhere to TMF digital archiving regulations
Recently published TMF report into clinical trial data management
Arkivum recently conducted industry research from over 200 life sciences organisations into the state of clinical trial data management.
The published report, TMF Futures, Keeping Data Alive shares some of the key findings from that research including the impact of COVID 19 on the clinical trial process, the challenges around clinical trial data management and what the future should look like. The report also features a number of interviews with experts across life sciences and data management.
You can download this report for free 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…
