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.
An effective eTMF digital archiving & preservation solution 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 data management solution for life sciences organisations that meets long-term compliance needs, at the same time supporting strategic, high-value use cases throughout the whole lifecycle of the clinical trial data.
In addition to the long-term data preservation mandated by regulators, the Arkivum solution acts as a dynamic central repository of information.
Accessible by all parties, improving productivity, dramatically reducing costs and creating the best possible environment for a successful inspection. Your clinical data will be future-proofed for decades or longer.
A guide to effective eTMF archiving and preservation
Recently published eBook provides an introduction to ensuring your eTMF is inspection ready
Arkivum has published an 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;
- Why preservation?
- TMF archiving myths
- Navigating regulations
- …and more.
Access the guide today.
What our customers say: Neuraly
Helping a revolutionary clinical-stage biotechnology company become GCP compliant
Celia Baula, Head of Quality and Director, R&D Program and Portfolio Management.
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08 Apr, 2020
eTMF archiving myths, misconceptions, and half-truths – here’s what you need to know
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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,…
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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…