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🇺🇸 Americas · Directory profile

Arkivum

GxP Compliant Data Archiving for Pharma

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Company 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.

Arkivum is listed in the NovaPharmaNews Supplier Hub as a Software & Digital Lab partner serving United States & Americas. Core focus areas include gxp archiving, data preservation pharma, alcoa+ compliance, clinical data storage, life sciences saas.

Industry categories: Software & Digital Lab. These tags help R&D, manufacturing, and procurement teams discover vendors aligned with their pipeline stage and compliance requirements.

Structured facts

Website
https://arkivum.com
Categories
Software & Digital Lab
Markets served
United States & Americas
Keywords
gxp archiving, data preservation pharma, alcoa+ compliance, clinical data storage, life sciences saas

Products & technologies

  • Gxp Archiving
  • Data Preservation Pharma
  • Alcoa+ Compliance
  • Clinical Data Storage
  • Life Sciences Saas

Markets served

  • United States & Americas

Industry categories

Company timeline

  1. — Profile published on NovaPharmaNews
  2. — Profile last updated

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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.