The Japan Times - Mastering Risk Assessment in Life Sciences: How Tricentis is Transforming Digital Validation

The Shift from CSV to CSA

Traditionally, software validation in life sciences has been a complex, paper-heavy process, creating bottlenecks that slow down digital progress. However, with the release of the FDA's CSA guidelines in 2022, organizations now have a clear pathway to risk-based validation. The CSA model promotes automation and streamlining of validation processes, reducing documentation burdens while ensuring compliance with regulations such as FDA 21 CFR Part 11.

Tricentis' Digital Validation Platform

A Unified Approach To support this transformation, Tricentis offers a comprehensive digital validation platform that seamlessly integrates testing, validation, and compliance management. This platform comprises three key solutions:

• Tricentis qTest: A centralized test management tool that provides full traceability across the software development lifecycle (SDLC). It enables teams to track assurance activities, optimize test case libraries, and automate audit trails.

• Tricentis Tosca: An AI-powered, no-code/low-code test automation solution that enhances risk-based testing. Tosca ensures comprehensive test coverage across IT landscapes, minimizing redundant testing efforts and improving efficiency.

• Tricentis Vera: A compliance management solution that streamlines validation approvals and audit processes. With automated e-signatures and pre- and post-execution validation workflows, Vera ensures digital compliance with regulatory requirements.

A Three-Step Approach to CSA Maturity

Life sciences organizations can transition to a CSA-driven approach by following three key steps:

1. Establish a Single Source of Truth - Consolidate software quality and validation data into one platform to improve traceability and decision-making.

2. Implement Risk-Based Testing - Prioritize test cases based on risk severity, probability, and detectability, ensuring optimized resource allocation.

3. Automate Validation Processes - Leverage digital workflows for approvals, reducing manual documentation efforts and accelerating compliance.

Accelerating Innovation in Life Sciences

By integrating these solutions, Tricentis enables life sciences organizations to bridge the gap between regulatory compliance and innovation. Companies can now release high-quality software faster, reduce compliance risks, and maintain audit readiness-all while meeting the rigorous demands of the healthcare and pharmaceutical industries.

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SOURCE: Tricentis

View the original press release on ACCESS Newswire

M.Sugiyama--JT