All of your data in one place
Adhering to requirements outlined by regulatory bodies is challenging, especially when new rules are being brought into effect (e.g. EU Regulation 536/2014 stipulates the retention of the eTMF for 25 years).
These requirements include ensuring that the data is accessible and readable for the entire retention period, in addition to ensuring data integrity is maintained throughout in line with the ALCOA principles.
Storing data on physical devices (hard drives, CDs etc), hosted file sharing sites (Dropbox, Sharepoint) and even, existing live systems are not viable options.
They cannot guarantee the long-term accessibility and readability of your data or ensure the safeguarding of these assets. Non-compliant storage approaches place you at risk of:
- Critical inspection findings
- Drug delays
- Longer inspections
- Reputational damage
Why did you need to access your archived data?*
Avoid risk of losing valuable data
Data, files and documents digitally stored for many years run the risk of becoming corrupted, damaged, lost or obsolete.
Our digital archiving software will enable you to archive and preserve your collections of information for many years. It ensures that your data is secure, findable and usable for as long as you need to retain it.
Most importantly, our software is fully validated for use in heavily regulated data management fields of clinical trials, scientific research papers and all complex datasets.
"It’s very satisfying to know that we can now provide a full, long-term records storage service that meets all the required standards."
Sandra Blake, Corporate Records Manager for Barts Health NHS Trust
Long-term compliance and alignment to ALCOA+
Arkivum provides a digital archiving and preservation solution, serving life sciences, pharma, and research institutes.
Our vendor independent solution supports clinical trial sponsors, CROs and sites in meeting clinical and all GxP archiving requirements as outlined by the FDA (CFR21 Part 11), EMA (GMP Annex 11) and MHRA. Additionally, it ensures alignment with ALCOA++ principles.
Inspection Readiness
Abiding by retention requirements and achieving and maintaining inspection readiness can be an ongoing and difficult challenge for any organisation.
Storing data on file-sharing sites, live systems, and offline media cannot safeguard and protect the data from untimely degradation.
Leaving your clinical data in an inappropriate system is putting it at risk from:
- Regulatory Fines
- Inspection Failures
- Reputational Damage
- Delays to Development
“The content of the clinical trial master file shall be archived in a way that ensures that it is readily available and accessible, upon request, to the competent authorities.”
EU Regulation 536 of the European Parliament
Services Product Blog & News About Us
Arkivum, a world leader in digital archiving and preservation, guarantees the past, present, and future of valuable data. Expert and meticulous in handling data and digitised assets in large volumes and multiple formats, Arkivum offers a fully managed, end-to-end service that streamlines complex workflows and regulatory processes.
© 2024 Arkivum Ltd. Company Reg No. 07530353 | VAT No. GB107755411