QASymphony / Blog / Tricentis qTest Integrates with Tx3 VERA to Support E-Signature Validation for FDA-Compliant Software Testing
Tricentis qTest Integrates with Tx3 VERA to Support E-Signature Validation for FDA-Compliant Software Testing
With the 12.2 Tricentis Platform update, Tricentis introduced an integration for qTest with Tx3 VERA (Validated Electronic Record Approval). Tx3 VERA is a quality and compliance platform that enables testers in the life sciences and other regulated industries to validate test steps with electronic signatures. The integration is also available for Tricentis Tosca.
Tricentis introduced the integration in response to the FDA and European Union’s regulations mandating that computerized systems and applications adhere to good manufacturing, laboratory, documentation and clinical practices.
The FDA’s Code of Federal Regulations, Title 21, Part 11 (better known as FDA 21 CFR Part 11), addresses the use and control of electronic records and electronic signatures. The European Union’s Annex 11 regulation also addressed computerized systems as part of the Good Manufacturing Process (GMP).
To date, most testers meet these regulations with paper-based documentation, which significantly slows down test cycles in an agile environment. Paper documents require hand-written signatures, which immediately creates an approval bottleneck that becomes extremely difficult manage with distributed teams.
The Tx3 VERA integration with qTestoffers validation on individual elements, such as test cases and test runs, within an agile test cycle. This allows teams to execute sprints and save validation-specific data that can be quickly and easy accessed in the event of an audit. The integration can be configured out-of-the-box and integrated into existing agile workflows, with flexible configuration options.
Features of the qTest Tx3 VERA integration include:
Configurable approval process with electronic signatures
Automatic locking of test case design templates which have been routed for pending approval
Automatic locking of test run executions which have been routed for pending approval
Configurable approval workflows from Jira Software, TricentisqTest and VERA
On-demand report generation of approval evidence for audit controls
Real-time views into status for each approval level