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	Define Approval Groups Define Approval Routes
Records Management Policy	Define record types (default record type at a minimum) Define Data fields to be imported into VERA Define Data fields to be hashed with VERA signature
Synchronization Policy	Configure information for connecting to third-party integration instance Third-Party Server URL VERA service account username created in the third-party application VERA service account password (encrypted)

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

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

Vera 2022.2 Documentation

VERA Technical Architecture Specification