For 2.0.0, we have a total of Twenty-Six (26) Enhancement items outlined below.
2.0.0 Release | ||||
Ticket ID | Name | Product | Module | Description |
78 | Implement a Javascript Tree for directories | eTMF | eTMF | Creation of the tree structure for directories. |
79 | Add and Edit Directory in Trial eTMF tool | eTMF | eTMF | Adds the Edit Directory function to the system. |
| 80 | Allow user to duplicate a directory structure with children | eTMF | eTMF | Implementation of the Copy function for directories. |
| 81 | Implement role access permission for eTMF directories | eTMF | eTMF | Implementation of the role permission system and associated managers. |
| 82 | Create document in directory and edit document | eTMF | eTMF | Addition of the Create Document function. |
| 83 | Implement document upload function | eTMF | eTMF | Implementation of file upload to eTMF Document. |
| 84 | Configure workflow in eTMF conductor tool | eTMF | eTMF | Implementation of managers and functions permitting the modification of eTMF workflows. |
| 85 | Implement audit framework for eTMF | eTMF | eTMF | Implementation of underlying framework to capture all Part 11 sensitive information. |
| 86 | Compare version difference for workflow configuration | eTMF | eTMF | Function to compare workflow versions for changes. |
| 87 | List and view versions of a document | eTMF | eTMF | Implementation of tools to permit review of prior versions of eTMF documents. |
| 88 | eTMF Audit Managers | eTMF | eTMF | Implementation of managers for the review of audited information in the eTMF. |
| 89 | eTMF Document Manager | eTMF | eTMF | Implementation of a central manager for the review and handling of all eTMF documents. |
| 90 | Move documents between eTMF directories | eTMF | eTMF | Addition of the Move action for relocating eTMF directories to other locations within the eTMF. |
| 91 | Implement document workflow transitions | eTMF | eTMF | Implementation of interface for executing stages of eTMF workflows. |
| 92 | Download eTMF documents | eTMF | eTMF | Implementation of the download function for individual and batch eTMF documents. |
| 467 | Provide and use default meta data and managed lists for the initial usage | eTMF | eTMF | Implementation of system defaults. |
| 468 | List documents belonging to a directory | eTMF | eTMF | Development of primary workspace window and its response to selection of directories in the Tree. |
| 536 | Allow full removal of documents from the trial tool. | eTMF | eTMF | Implementation of utilities and process to delete documents in the eTMF. |
| 558 | eTMF Blinding Support: Add permissions for user blinding | eTMF | eTMF | Creation of blinding permissions for eTMF user roles. |
| 559 | eTMF Blinding Support: Add blinded configuration for documents | eTMF | eTMF | Implementation of blinded status for eTMF documents. |
| 560 | eTMF Blinding Support: Hide blinded documents for blinded users | eTMF | eTMF | Implementation of system view behavior that restricts access to blinded documents based on document blinded status, and user role's blinding permission. |
| 570 | Delete directory from eTMF trial | eTMF | eTMF | Implementation of functions to delete directories from eTMF tree. |
| 575 | Add workflow for certified copies | eTMF | eTMF | Implementation of a default worfklow for Certified Copy. |
| 579 | Add default meta data Date Convention and Date for Documents | eTMF | eTMF | Creation of system default metada Date Convention and Date for Documents. These relate to the date convention and the recorded dates for artifacts in the TMF Reference Model. |
| 591 | Upgrade System meta data and distribute meta data from the Conductor | eTMF | eTMF | Implementation of Conductor tool's ability to pass settings to connected Trial tools. |
| 695 | Add custom Metadata and custom Managed List Support for eTMF | eTMF | eTMF | Implementation of utilities for the support and creation of custom Metadata and Managed Lists for use in eTMF trials. |
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