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.
80Allow user to duplicate a directory structure with children
eTMF

eTMF


Implementation of the Copy function for directories.
81Implement role access permission for eTMF directories

eTMF


eTMF


Implementation of the role permission system and associated managers.
82Create document in directory and edit document

eTMF


eTMF


Addition of the Create Document function.
83Implement document upload function

eTMF


eTMF


Implementation of file upload to eTMF Document.
84Configure workflow in eTMF conductor tool

eTMF


eTMF


Implementation of managers and functions permitting the modification of eTMF workflows.
85Implement audit framework for eTMF

eTMF


eTMF


Implementation of underlying framework to capture all Part 11 sensitive information.
86Compare version difference for workflow configuration

eTMF


eTMF


Function to compare workflow versions for changes.
87List and view versions of a document

eTMF


eTMF


Implementation of tools to permit review of prior versions of eTMF documents.
88eTMF Audit Managers

eTMF


eTMF


Implementation of managers for the review of audited information in the eTMF.
89eTMF Document Manager

eTMF


eTMF


Implementation of a central manager for the review and handling of all eTMF documents.
90Move documents between eTMF directories

eTMF


eTMF


Addition of the Move action for relocating eTMF directories to other locations within the eTMF.
91Implement document workflow transitions

eTMF


eTMF


Implementation of interface for executing stages of eTMF workflows.
92Download eTMF documents

eTMF


eTMF


Implementation of the download function for individual and batch eTMF documents.
467Provide and use default meta data and managed lists for the initial usage

eTMF


eTMF


Implementation of system defaults.
468List documents belonging to a directory

eTMF


eTMF


Development of primary workspace window and its response to selection of directories in the Tree.
536Allow full removal of documents from the trial tool.

eTMF


eTMF


Implementation of utilities and process to delete documents in the eTMF.
558eTMF Blinding Support: Add permissions for user blinding

eTMF


eTMF


Creation of blinding permissions for eTMF user roles.
559eTMF Blinding Support: Add blinded configuration for documents

eTMF


eTMF


Implementation of blinded status for eTMF documents.
560eTMF 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.
570Delete directory from eTMF trial

eTMF


eTMF


Implementation of functions to delete directories from eTMF tree.
575Add workflow for certified copies

eTMF


eTMF


Implementation of a default worfklow for Certified Copy.
579Add 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.
591Upgrade 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.
695Add 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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