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Tricentis Vera

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"Tricentis Vera is a digital validation management platform designed for life sciences organizations that must demonstrate software compliance with regulatory standards including FDA 21 CFR Part 11. It is a type of Computer Systems Validation (CSV) solution that helps regulated organizations streamline approval workflows, manage electronic records, and embed compliance controls directly into modern software delivery practices. Vera modernizes traditional document-centric Computer Systems Validation by replacing paper-based processes and manual audit trails with automated, auditable digital workflows. It integrates with testing and quality management tools including Tricentis Tosca, Tricentis qTest, and Jira, enabling teams to generate compliant validation evidence as a byproduct of their existing testing activities rather than as a separate documentation effort. Key capabilities include: - 21 CFR Part 11 compliant electronic signatures and record management - Centralized review and approval portal across integrated testing and ALM tools - Pre and post-execution approval workflows for both manual and automated Tosca tests managed in qTest - Record locking during active approval workflows to prevent unauthorized changes - Full audit history and auditable electronic records for regulatory inspection readiness - Technical controls that reduce the risk of human error and compliance deviation - Integration with Agile and DevOps environments to support continuous compliance Vera is designed for quality and regulatory affairs teams at pharmaceutical, medical device, and biotechnology companies that are adopting Agile or DevOps delivery models and need to maintain compliance with FDA and other regulatory bodies. It enables these organizations to accelerate software delivery without compromising the rigor required for regulatory validation documentation."

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