eTMF Archiving & Digital Preservation Tool | Fully Compliant

Ensure your eTMF is inspection ready

A validated data archiving and preservation software solution, supported by a robust QMS

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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.

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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. 

Read the full guide here

Our solution guarantees that your data is:

Secure

Our validated (CSV) solution provides peace of mind that your data is safe

Findable

Easily locate the right information when you need it

Accessible

Provide appropriate access to the people who need it

Usable

Avoid file obsolescence with automatic format updates

Auditable

A complete audit trail of who has accessed what

Compliant

Adhere to ever changing industry requirements and regulations.

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What our customers say: Neuraly

Helping a revolutionary clinical-stage biotechnology company become GCP compliant

"Arkivum’s team was knowledgeable, very helpful and responsive from beginning to end. We are looking forward to working with the team for subsequent eTMF archiving needs."

Celia Baula, Head of Quality and Director, R&D Program and Portfolio Management.

Read the full case study