Complying with eTMF retention regulations is challenging
Traditional storage practices do not guarantee long-term protection, access and readability
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 is data preservation crucial?
- Common eTMF archiving mistakes
- Navigating retention regulations
- …and more.
Access the free 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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