Archives

Q.1 What technology is used for long-term storage and archiving of study eTMFs?

Answer: The eTMF archiving mechanism is integrated into the core eTMF system. Once a study is unpublished, its content is transferred to a secondary content store optimized for secure, long-term retention. This secondary store supports immutability, metadata retention, and audit trails.

Q.2 Is this long-term storage a separate solution, or is it part of the main system?

Answer: It is not a separate solution. The archiving feature is built into the core eTMF platform. The TMF status changes to reflect its lifecycle phase, but the system remains unified across active and archived states.

Q.3 How are archived TMFs categorized and managed within the system?

Answer:

  • Active Archive: The TMF remains fully accessible for audits and inspections.
  • Passive Archive: The TMF is offloaded to a cost-efficient, long-term storage layer. While no longer in active use, it remains retrievable with full integrity and compliance controls.

Q.4 Is an architecture diagram available to illustrate this archiving concept?

Answer: The request for an architecture diagram is noted. We can share a visual representation of the archiving concept upon request to support better understanding of the infrastructure.

Q.5 What is the current expected SLA for archival? Is it possible to reduce the time frame to less than two weeks?

Answer: This is dependent on the number of documents exported. Our current SLA for the archive is set at 1 week/10000 Documents. Raise a ticket with the Trial Interactive support team for additional information.

Q.6 Is it possible to provide the verification of checksums that compares what was archived to what is in TI as a report?

Answer: The Checksum documents are exported along with the archives. So, we can add the file as part of the export when we send it to the client. This should be requested in the Archive Request Form.

Q.7 What kind of encryption do we do by default for ZIP files?

Answer: Currently, we use AES -256 Encryption type for zipping folders.