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 | Open-source web framework for .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

Tricentis Vera

An enterprise application manufactured by Tricentis 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

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

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