AUSTIN, TX, 2025年4月1日 - (JCN Newswire) -The life sciences industry is rapidly evolving, with digital transformation at the core of its advancement. Amid increasing regulatory scrutiny and the need for speed in software development, organizations face a critical challenge: ensuring compliance while accelerating innovation.Tricentis, a leader in enterprisecontinuous testing, provides a holistic solution to modernize computer system validation (CSV) and embrace a more efficient computer software assurance (CSA) model.
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 torisk-based validation. The CSA model promotes automation and streamlining of validation processes, reducing documentation burdens while ensuring compliance with regulations such asFDA 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:
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.
Office
Email: office@tricentis.com
Tel: +1 737-497-9993
SOURCE: Tricentis
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