Modernize and streamline computer systems validation
A leading digital validation solution for life sciences organizations to expedite critical approval, verification, and compliance management processes. It provides Title 21 Part 11 compliance and seamlessly integrates with market-leading tools for regulated application testing, such as qTest, which can be integrated with SAP Solution Manager and SAP Cloud ALM, allowing organizations to leverage the features of both qTest and Vera.
Overview
Replace documents with electronic records
Seamlessly request and capture Code of Federal Regulations Title 21 Part 11 compliant electronic signatures as testing and validation activities occur and capture all relevant approval and verification data associated with each record within Vera.
Integrate with leading software test and delivery tools
Currently integrates directly with Tricentis qTest, Atlassian Jira and Idera Xray. Easily support test automation Tricentis Tosca and other automation tools through qTest.
Standardize tools across good practice guidlines and non-good practice projects
With the ability to designate GxP and non-GxP projects and define when Vera functionality is applied, users are easily able to standardize their software testing tools across both their regulated and non-regulated software testing, allowing for a more standardized approach across the enterprise.
Details
Solution type
Extensions and Add-ons
Industry
Life Sciences
Compatibility
Works with
Features
Comply with Code of Federal Regulations Title 21 Part 11
Apply technical controls over defined processes to drastically reduce the risk of compliance deviation while automating the capturing of traceability and audit history to remove manual effort and reduce risk of human error.
Centralized review and approval portal
Vera provides a central portal across tools and teams users can access to view relevant review and approval tasks assigned to their role, as well as view real-time status of pending review and approval tasks.
Technical control and lock records
Vera enables technical controls to lock records that are either in a "routing for approval" or "approved" state to ensure data and record integrity throughout the testing lifecycle, drastically reducing the risk of compliance deviation in computer systems validation.
Plans and pricing
All plans include:
Private Cloud
SaaS-based solution that is designed to meet the regulatory compliance requirements of Life Science organizations.
Includes 25 Users Price unavailable in this region- Minimum contract 1 year
SaaS-based solution that is designed to meet the regulatory compliance requirements of Life Science organizations.
Includes 25 Users Tosca Adapter for Micro Focus ALM
Directly integrate Vera with Micro Focus ALM (Quality Center or ALM required)
Support pre and post-execution of Tosca automated tests with the included Tosca adaptor for ALM
Includes 25 Users Price unavailable in this region- Minimum contract 1 year
Directly integrate Vera with Micro Focus ALM (Quality Center or ALM required)
Support pre and post-execution of Tosca automated tests with the included Tosca adaptor for ALM
Includes 25 Users
