Overview
Arkivum provides a SaaS-based, GxP validated digital preservation and archiving solution for pharmaceutical and life sciences organizations. It ensures long-term data integrity in compliance with regulations like FDA, EMA, MHRA, and ALCOA+ principles. The platform supports storage of clinical, lab, regulatory, GMP, quality, and corporate records, offering instant access and vendor independence.
Frequently asked questions
- What regulatory standards does Arkivum comply with?
- Arkivum is GxP validated and aligns with FDA, EMA, MHRA regulations, including ALCOA+ principles for data integrity, supporting clinical trial sponsors, CROs, and sites.
- What types of data can Arkivum archive?
- It stores clinical records (eTMF, eCRF, EDC, ePRO), lab data, regulatory datasets (SDTM/ADaM), GMP records, quality documentation, and corporate assets like patents.
- Is Arkivum suitable for long-term data access?
- Yes, the SaaS solution guarantees 100% long-term data integrity with instant accessibility for stakeholders, purpose-built for enduring preservation.