Definitions
| Term | Definition |
|---|---|
| Approval Policy | A collection of business rules establishing approval routes for electronic records. |
| Approval Route | The approval tasks and approval task order associated with an electronic record |
| Approval Task | Assignment to approve or reject an electronic record |
| ASP.NET Core | A cross-platform, high-performance, open-source framework for building modern, cloud-based, Internet-connected applications |
| Data field | A field that is part of the core data that comprises an electronic record, as opposed to a metadata field, which contains supplementary information about a record |
| Electronic record | Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. (As defined in 21 CFR §11.3) |
| Metadata field | A field that contains supplementary information about an electronic record, as opposed to a data field, which is part of the core data comprising the electronic record |
| MongoDB | An object-oriented and scalable document database utilized by VERA. MongoDB is based on the NoSQL document store model. The data objects are stored as separate documents inside a collection instead of storing the data into the columns and rows of a traditional relational database. |
| Records management policy | A collection of business rules establishing data fields for electronic records |
| system adapter | A software component in the VERA application architecture that specializes in providing a software interface between VERA and an external software application. As it relates to the VERA Records Management Policy, a system adapter is responsible for ensuring the rules of the records management policy are enforced within the associated external system |
| Tx3 VERA | An enterprise application manufactured by Tx3 Services, LLC that specializes in enforcing shared business policies pertaining to the control of electronic records across multiple systems. |
| VERA application architecture | A collection of individual software components (server applications, system adapters, and user interfaces) that comprise the VERA application |
Overview
Tx3 VERA is an enterprise application that enforces shared business policies pertaining to the approval of electronic records across multiple systems. Using VERA, an organization can define one or more policies describing the types of electronic records the organization maintains, along with business rules describing the expected user access permissions, electronic workflows, and electronic approval rules for each type of record. These policies can then be enforced across all the organization’s information systems that are integrated with VERA.
Software Features and High Level Architecture
The VERA provides the following features:
- Electronic signatures for 21 CFR Part 11 Compliance
- Routing records for approval and assigning approval tasks
- Approving and signing electronic records
- Rejecting records and capturing rejection reason
- Withdrawing approval routes
- Revising records and capturing revision history
- Configurable Approval Tasks and Approval Routes
- Configurable Approval Route association to entities and attributes
- eSignature and record verification
- Integration with Atlassian Jira
- Integration with Tricentis qTest
VERA application and integration diagram
VERA Policy Files
VERA uses policy files (in JSON format) to define configurations and business rules. The following policy files are used to fulfill the below purposes.
Policy File | Purpose |
|---|---|
| Approval Policy |
|
| Records Management Policy |
|
| Synchronization Policy |
|
VERA Server
The VERA server is an API Gateway built on ASP.NET Core
VERA Server modules
| Modules | Description |
|---|---|
| API Gateway | single access point for underlying VERA application modules |
| Webhook listener | monitors integrated system events and executes associated routing for approval and cancel approval route triggers |
| Records | Electronic records management |
| Polices | executes policies |
| Signatures | applies 21 CFR Part 11 complaint signature and hash |
| System Adapters | 3rd party integrations |
| Users | User management, IdP association and approval role definition |
| Routes | Applying approval routes to records and executing approval tasks |
| Verification | Verify records and signatures against record and signature hash |
Web Portal
The VERA Web Portal displays records and associated approval tasks for users to approve or reject electronic records. The portal also provides audit history information and an administrator portal.
VERA Web Portal
VERA Database
NoSql, Document Database stores records, signatures, approval routes, users and approval roles.
Jira Integration
Jira integration with VERA provides electronic record and signature compliance for Agile / DevOps organizations.
Jira and VERA integrated workflow
Jira integration with VERA is a combination of the VERA Jira Adapter, Jira workflow with webhooks and the VERA Electronic Signatures for Jira App. Detailed instructions for Jira configuration can be found here. Jira workflow is configured with the following state transitions and conditions.
Jira integration diagram
Sample Jira workflow with VERA integration
| Step Name | Transition | Transition To | Conditions | Post Function | Read-Only | Delete Denied | Move Denied |
|---|---|---|---|---|---|---|---|
| To-Do | Start Work | In Progress | |||||
| In Progress | Start Approval(s) | Routing for Approval | Start VERA Approval Route Webhook | Y | Y | Y | |
| Routing for Approval | Withdraw Approval(s) | In Progress | Cancel VERA Approval Route Webhook | Y | Y | Y | |
| Routing for Approval | Complete Approval | Approved | Only users in project role <Vera Service Account> can execute this transition | Y | Y | Y | |
| Routing for Approval | Complete Rejection | Rejected | Only users in project role <Vera Service Account> can execute this transition | Y | Y | Y | |
| Rejected | Withdraw Approval(s) | In Progress | Cancel VERA Approval Route Webhook | Y | Y | Y | |
| Approved | Y | Y | Y |
| Note | ||
|---|---|---|
| ||
To-Do and In Progress transitions are examples of Jira workflow transitions and can be replaced with customer specific Jira workflow. |
The VERA Electronic Signatures for Jira App displays the VERA Approval Route with approval task links and any rejection reasons in Jira.
VERA Electronic Signature for Jira App
qTest Integration
VERA integration with qTest provides pre-execution and post execution approval capabilities for qTest Test Cases and Test Results.
qTest and VERA integrated workflow
qTest integration with VERA is a combination of the VERA qTest Adapter and the VERA external integration provided by Tricentis qTest.
qTest integration diagram