Genius eDocumentum

Long-Term Document Archiving

Genius eDocumentum

Long-Term Document Archiving

Genius eDOCUMENTUM is a cloud service and validate solution that enables the secure, long-term retention of clinical trial documents, accessible online for instant viewing and sharing among the different authorized stakeholders and for auditors or regulators in case of inspections or requests.

Genius eDOCUMENTUM

Features

  • Available as a cloud subscription service, offering read-only access to the trial documents to authorized personnel.
  • Provides a robust, scalable, fault-tolerant, cloud-ready, and extensible architecture to store and control all study documents
  • Direct connection with Veeva Vault eTMF
  • Possible integration with different eTMF applications
  • Controlled repository access and improved compliance through fine-grained authentication, authorization, and audit trail
  • No risk of media deterioration and/or obsolescence
  • Fast set-up (10 days)
  • Access granted both on a continuous basis (24/7) or on demand, when needed
  • Fully compliant with articles 57 and 58 of the new European Regulation on clinical trials and with GCPs
  • Offered in two versions for the long-term archive of both the eTMF and eISF documents
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