Every file in the document management has a details view that offers a host of information about the document, versions, metadata and more. This article will review the functionality in the following Panes:
1. Home
2. Versions
3. Related
4. Metadata
5. Access
6. Audits
1. Home Pane
Home is displayed first by default. Current Version number, type of document, author, date/time stamps, assignee and general workflow information may be accessed and viewed in this screen. User actions allowed are determined by roles and permissions.
2. Versions Pane
a) Versions displays information about each version of the document. A numerical system is applied in addition to status, type (source/pdf) and description. If the user has permission, a download icon is available next to the file name as well as a delete trash can icon. Clicking on the file name will enable you to update the filename for the version (requires edit permission).
b) Actions accessed via the ellipses are determined by user permissions. The menu displays actions the user can perform on the version.
3. Related Pane
a) Related pane includes five sub-tabs: Related Docs, Submissions, Related Activities, Projects and Alias Locations.
b) Related Docs links documents, files or content together. Use cases: Protocol is linked to the Clinical Overview or Medical Monitoring Plan and Medical Contact Report and Medical Monitoring Decisions would all be linked. Or an SOP could be related to a form and work instruction.
c) Related Submissions lists where the document or file is placed within a submission and application. In the example below: KV-531 Protocol version 0.3 is located in two: Regulatory Submission, IND 123456, Sequence 0006 and CTIS: Initial CTA.
d) Related Activities link the document or file version to an activity. In the example below, KV-531 Protocol version 0.3 is linked to a Regulatory Activity: Submission -2023-11 Protocol Amendment.
e) Related Projects link the document or file version to a project task. In the example below, KV-531 Protocol version 0.3 is linked to a FDA Submission- IND project.
f) Alias Locations shows aliases to the document or file version in another location. The feature is useful when content is required or applies to two or more cabinets, folders, or sections. Instead of creating copies, Alias allows a reference link.
In the example below, KV-531 Protocol v.03 is referenced or has an alias location in cabinet KV-001-PI Trial. Path and link to the location is included.
4. Metadata Pane
a) Metadata Pane includes the information about a document or file version. In the example below, KV-531 Protocol version 0.3 is selected and requires seven (7) metadata fields to be filled out as indicated by a red badge at the pane's tab and a red "*." next to each required field. Other details provided are Document Type, Category and Artifact.
b) Updating values requires Edit permission on the document.
c) Metadata is configured per workspace. Kivo utilizes industry-standard metadata, inclusive of the TMF Reference Model and EDM reference model as seen below.
6. Access Pane
Access Pane describes the Groups and Users with their corresponding Permissions on the document or file version. This pane is read-only. Workspace Managers can switch to Manager mode to make changes to document-level permissions.
7. Audits Pane
Audits Pane shows a list of all actions taken on the document or file version, along with who performed each action. An Excel formatted list may be downloaded by clicking the "Download Audit Log" link.