Code eTMF is Cliantha’s proprietary, 21 CFR Part 11, web-enabled trial master repository software for all the study documentation. Software provides regulatory agencies a clear view of the story of clinical trials to ensure compliance with GCP.
Functionalities are designed especially to support global clinical operations and trial management. The system supports simple Quick Study, Site TMF template creation, including folders and placeholders for files Decluttered system with focus to ease TMF Management process.
Custom metadata setup and management with dynamic metadata report Specific customization options based on study requirements, Built in QC workflow.
- Process Management and customized workflow.
- Trial and Site Master file structure.
- User Role can be customized.
- Alerts and Email Notification.
- Role based access control.
- Dynamic search of TMF and Site master files.
- Electronic Signature.
- Reporting and Dashboards.
- Archival and Retrieval of all documents as a zip file.
- Role based access: for better operational efficiency, restricted access will be given each user. This will decrease risk of breaches and data leakage.
- Audit Trail: Comprehensive audit trial is available which follow records back to their origin. Each and every activity has been captured.
- 21 CFR part 11: System is fully validated with detailed IQ,OQ and PQ,
- We have performed IQ, OQ and PQ with 21 CFR Part 11 compliance, with system is 21 CFR part 11 compliant each and every record can be tracked to its source.
- Every entry have been updated with time and user name along with first and last name.
- Only authorized person can access the system. The system have been validated to operate correctly.
- IIS have been authenticated using SSL, with SSL enabled the browser encrypts all data sent to the server and decrypt all data coming from server