Stefanini offers flexible, scalable validation services tailored to the Life Sciences industry — ensuring compliance, minimizing risk, and supporting efficient system delivery.
For over two decades, Computer System Validation (CSV) has evolved from traditional GMP and GLP approaches to today’s risk-based frameworks. As critical business processes increasingly depend on complex software — such as ERP platforms, clinical trial tools, and data systems — the need for effective validation is greater than ever.
Stefanini specializes in risk-based CSV tailored to the Life Sciences sector. We provide scalable, cost-effective validation services that align with your system complexity, project timelines, and regulatory requirements. Whether for one-off needs or long-term programs, our experts support both direct and indirect impact systems to ensure audit-readiness and full compliance.
What You’ll Find in the Brochure:
- Development of scalable validation frameworks for any system complexity
- Validation of ERP systems, clinical trial software, lab data platforms, and manufacturing control systems
- Support for AI integrations and cloud-based systems
- Seamless integration of validation activities into project delivery
- Constantly updated document accelerator kit
- Compliance with FDA 21 CFR Part 11 and electronic signature standards
- Strategic and tactical consulting for successful execution
Why Choose Stefanini:
✔ Cost-effective compliance through intelligent, risk-based validation
✔ Extensive experience in Life Sciences systems and regulations
✔ Strategic support aligned with business priorities
✔ Validation expertise across laboratory, clinical, manufacturing, and IT systems
✔ Scalable services tailored to your project scope
Is Your Validation Strategy Audit-Ready?
Download our brochure to discover how Stefanini can help you simplify validation, reduce risk, and ensure regulatory compliance across your Life Sciences systems.