VERA Technical Architecture Specification

Purpose

This document provides a technical system overview of VERA version 3.

Table of Contents


Definitions

TermDefinition
Approval PolicyA collection of business rules establishing approval routes for electronic records.
Approval RouteThe approval tasks and approval task order associated with an electronic record
Approval TaskAssignment to approve or reject an electronic record
ASP.NET CoreA cross-platform, high-performance, open-source framework for building modern, cloud-based, Internet-connected applications
Data fieldA 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 recordAny 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 fieldA 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
MongoDBAn 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 policyA collection of business rules establishing data fields for electronic records
system adapterA 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 VERAAn 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 architectureA 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

ModulesDescription
API Gatewaysingle access point for underlying VERA application modules
Webhook listenermonitors integrated system events and executes associated routing for approval and cancel approval route triggers
Records

Electronic records management

Policesexecutes policies
Signaturesapplies 21 CFR Part 11 complaint signature and hash
System Adapters3rd party integrations
UsersUser management, IdP association and approval role definition
RoutesApplying approval routes to records and executing approval tasks
VerificationVerify 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 NameTransitionTransition ToConditionsPost FunctionRead-OnlyDelete DeniedMove Denied
To-DoStart WorkIn Progress




In ProgressStart Approval(s)Routing for Approval
Start VERA Approval Route WebhookYYY
Routing for ApprovalWithdraw Approval(s)In Progress
Cancel VERA Approval Route WebhookYYY
Routing for ApprovalComplete ApprovalApprovedOnly users in project role <Vera Service Account> can execute this transition
YYY
Routing for ApprovalComplete RejectionRejectedOnly users in project role <Vera Service Account> can execute this transition
YYY
RejectedWithdraw Approval(s)In Progress
Cancel VERA Approval Route WebhookYYY
Approved



YYY

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