Arkivum has launched A-Stor Pharma, a digital data archiving service developed specifically to meet the needs of the healthcare and life sciences industries. A-Stor Pharma is a managed and entirely scalable cloud storage service that integrates with the customer's existing infrastructure and provides 100 per cent secure long-term data storage. It enables life sciences companies to become fully compliant with industry regulations, such as the 21CFR Part 11 and GMP Annex 11 guidelines, and is particularly suited to bio-technology, clinical trial management and pharmacovigilance businesses, where records need to be stored for extended periods of time, but remain accessible at short notice.
FDA regulation 21 CFR Part 11 and EU GMP Annex 11 require all electronic records to be protected and offer proven authenticity, while remaining easy to retrieve throughout the mandatory data retention period. Arkivum offers complete transparency in the processes, technologies and facilities it uses to store data. A-Stor Pharma operates as an open system and by integrating end-to-end checksum technologies, is able guarantee authenticity, confidentiality and data integrity.
For organisations required by law or regulation to store all information onsite, Arkivum offers OSCAR (On-Site Cloud Archive), a cloud archiving solution. The remotely managed, all-in-one pod solution provides the same data integrity promise and level of service as A-Stor Pharma, but within a corporate firewall.