Audit Trail

Q.1 What does the overall archiving concept look like?

Answer: The archiving concept focuses on lifecycle management and regulatory durability. It includes:

  1. Retention & Compliance: Alignment with GCP, FDA, EMA requirements.
  2. Technology Continuity: No format/platform change between active and passive states.
  3. Operational Efficiency: Reduces load on the live system by offloading passive data.
  4. Security & Auditability: Full audit trails, metadata retention, and access control are maintained across all phases.

Q.2 Is the Audit Trail report based on date, activity, or both?

Answer: The Audit Trail contains both date and activity but the report itself is executed using a date range.

Q.3 How long is the Audit Trail information retained?

Answer: All audits are maintained in perpetuity.

Q.4 Can TI provide a sample of the Audit Trail report as part of the bid defense demo?

Answer: Yes

Q.5 When a document is Purged, does the system retain the ability to retrieve the Audit Trail associated with the purged document?

Answer: Yes. While the document itself is purged from the system and the content of that document is fully removed, Trial Interactive retains the ability to provide an Audit Trail showing actions performed in relation to a purged document.

Q.6 Are security-related logs protected and secured against unauthorized change? How does the company manage the security logs and that the IT security is complying with the regulations such as does TransPerfect have controls to prevent data leakage and data loss prevention?

Answer: The Audit Trails are immutable and cannot be changed. The security logs are kept immutable, internal systems are tracking security notifications which are also immutable, any TransPerfect receives is check summed and encrypted and any changes can easily be seen. There are a lot of different controls in place to make sure that there is no unauthorized change to data.

Q.7 What are the Audit Trail activities?

Answer: The Audit Trail activities are explained as follows:

  • TI Audit Trail considers viewing a document to be equivalent to capturing the information, and audits the viewing of every document. There is no separate audit event for downloading from the viewers, because TI supports multiple viewers and they do not allow the capture of this action. Instead, TI audits the act of viewing the document itself.
  • For other Export options, TI fully audits each and every time content is downloaded, either singly or in bulk.
  • To lock content down securely, TI currently offers a feature called DRM to disable the download completely from the TI Viewer. This feature can be enabled to ensure documents cannot be downloaded from the Viewer.

Q.8 What are Audit Trails for Trial Interactive preserved and archived?

Answer: Trial Interactive includes detailed audit logs showing the field changed, the old value, the new value, the data and time, and the reason for change. Electronic signatures are indicated in the audit trail as well.