Computer Systems Validation

At NexInfo, we adopt a pragmatic, risk-based approach to Computerized System Validation (CSV), ensuring your systems comply with regulatory requirements while maintaining optimal functionality and reliability. We start by clearly defining your objectives, then assess each system or asset based on rigorous safety, quality, and integrity benchmarks.

Our approach combines deep industry knowledge with expertise in regulatory frameworks to deliver practical, maintainable compliance solutions tailored to both your immediate needs and long-term goals. 

NexInfo’s CSV/CSA Services Include: 

1. Global Enterprise Systems Compliance : NexInfo leverages extensive experience in global business systems and regulatory compliance to help organizations in FDA-regulated industries maintain seamless compliance. By integrating regulatory standards with business operations, we enable efficient compliance solutions across complex, global supply chains, ensuring your systems support both business continuity and regulatory adherence. 
2. Manufacturing Systems Compliance : NexInfo offers comprehensive support for the validation of manufacturing systems, including Systems Validation, Control Systems Technology, Building Management Systems (BMS), Computer Integrated Manufacturing (CIM), and Manufacturing Execution Systems (MES). Our experts apply industry best practices to validate, qualify, and maintain these systems, ensuring compliance while minimizing disruptions to production workflows. 
3. Laboratory Systems & Instrumentation Compliance : We specialize in validating laboratory systems such as Laboratory Information Management Systems (LIMS) and Chromatography Data Acquisition Systems (CDAS), ensuring accurate, reliable, and compliant data management. NexInfo’s team of technical consultants apply risk-based strategies to qualify instruments and systems, maintaining alignment with regulatory standards while optimizing laboratory operations. 
4. IT Infrastructure/Component/Data Center Qualification : NexInfo’s expertise extends to IT infrastructure validation, providing a risk-based approach to qualifying systems, networks, and data centers. We support clients in defining and implementing strategies for IT infrastructure compliance, focusing on performance, data integrity, and regulatory alignment. Whether it’s system qualification or ensuring infrastructure meets the highest standards, NexInfo ensures that your IT environment is fully compliant and resilient. 

At NexInfo, we combine technical expertise with an in-depth understanding of regulatory requirements to provide robust, scalable solutions that meet the specific needs of your business.

Our team applies a proactive, risk-based methodology to every project, ensuring compliance is achieved without compromising performance or reliability across your systems.