A Fortune 500 Life Sciences enterprise chooses Arkivum to provide long term management of its regulated research data generated by its FDA Class III medical devices. Arkivum will provide a long-term data management service and solution for the organisation to manage its GxP regulated research data in a compliant and scalable manner, ensuring digital data preservation, future access and usability of its data for years to come.
Arkivum will play a pivotal role as the enterprise is transforming their data strategy and data management workflows to remove silos generated as a result of acquisitions to build a sustainable, centralised long-term data management strategy.
The main drivers behind this initiative are to make the regulated data generated by the enterprise systems more usable for further research and discovery purposes; easily reportable on for auditing and regulatory purposes; and more shareable securely to create increased collaboration opportunities across the industry.
The Arkivum solution, which will run on the Enterprise private AWS instance, initially focuses on their requirement to keep historical GxP outputs from medical instruments for at least 20 years and coincides with the data being transitioned onto Amazon’s AWS.
An important part of the decision in choosing Arkivum was to select a software provider who can deliver secure, robust long-term data management workflows and capabilities across a cloud environment while meeting the most stringent data related GxP requirements.
George Waidell, VP of Life Sciences at Arkivum adds, “Arkivum will provide our customer with complete confidence their research data will be accessible and usable for as long as they need it. We’re excited to be working with such a prolific world leading expert in their field to deliver this and support them in their continued innovation”.
Arkivum is also working with this customer to create a sharable data solution where this organisation’s customers will be able to send their data to the cloud-based solution and share that data, minus any Personally Identifiable Information (PII), with approved third parties such as CROs or regulators.