Computer System Validation (CSV)

At Performance Validation, we pride ourselves in bringing clients peace of mind with efficient, timely and high-quality project work that meets Computer System Validation (CSV) regulatory requirements and streamlines business operations.

Our professionals are committed to integrity and excellence with a focus on practical implementation of compliance and providing customized solutions – while never losing sight of your goals, scope, and priorities.

Performance Validation stays current on the latest industry standards and best practices, such as Good Automated Manufacturing Practices (GAMP), AAMI TIR-36, FDA Guide to software validation, and Data Integrity and Compliance with CGMP FDA Guidance. We have successfully developed and deployed a full suite of CSV documentation for systems that range in complexity from spreadsheet validation to integrated platform solutions.

Regulatory compliance is at the core of any computer system validation project. We specialize in efficiently and effectively meeting regulatory requirements and industry standards – including 21 CFR Part 11 (Part 11), cGMPs, GLPs, and GCPs for computerized system compliance. We can adhere to your internal processes and procedures or we can implement our own proven methodologies.

Performance Validation can help you achieve FDA compliance for a wide range of computer system types including ERP, LIMS, LIS, EDC, eQMS, laboratory instrumentation, and other business information systems. We also have extensive capability with SCADA and PLC manufacturing execution system validation. With decades of experience in computerized system validation, Performance Validation is positioned to deliver a right-sized and integrated solution.

Have Questions? Set up a no-obligation initial consultation and learn how Performance Validation can design a CSV solution for you. Contact us today.

Learn about our CSV Service Offerings

Learn about our CSV Experience