System validation in Life Sciences is the process of verifying that GxP systems are developed, installed, and maintained in accordance with regulatory requirements and industry best practices. To ensure compliance with all applicable regulatory requirements, all GxP systems must be qualified and validated for intended use. This can be a complex and time-consuming process that requires specialized expertise not always available in-house.
We have the experience to guarantee that your systems are validated to achieve high product quality, patient safety and compliance with industry standard data integrity expectations.
Our team of over 350 specialists has expert knowledge and experience across all GxP domains and uses a tailored risk-based approach to make your systems compliant. Through our solution, we ensure that all IT systems, laboratory and production equipment are fully compliant and supported by validation documentation.
Our approach allows companies to accelerate product market entry while ensuring compliance with relevant quality regulations and standards.
System Validation for Life Sciences
Accelerate market entry with optimal qualification and validation. Sopra Steria offers a comprehensive System Validation Solution that addresses the full spectrum of qualification and validation requirements for Life Sciences companies.
We offer a comprehensive System Validation Solution that addresses the full range of qualification and validation requirements for Life Sciences companies.
What our solutions deliver:
- Unburdening. We unburden your staff by planning, managing and/or executing all your initial and periodic qualification/validation tasks.
- Workload reduction. By managing qualification/validation activities, we reduce the workload of the internal qualification/validation engineers. This leaves more time to focus on the more challenging projects and equipment.
- Lean optimization. By introducing our team and work management tool, we measure performance and efficiency, and facilitate improvements. The tool provides automated planning options for repetitive tasks as well as reporting.
- More uptime. By managing and planning qualification/validation activities in the team and work management tool, we guarantee high quality and on-time delivery within budget