Computer System Validation (CSV) / Computer System Assurance

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As experts in Computer System Validation (CSV) we utilize Computer System Assurance (CSA) methodology to assist life science companies in navigating regulatory requirements and achieving their data integrity goals. Leveraging technology and our expertise, we aim to minimize risk and ensure adherence to 21 CFR Part 11.  With us as your CSV/CSA partner, you'll have strong confidence in your data integrity program.

Specialized Services:

• Enterprise System Validation
• Equipment & Instrument Validation
• Data Integrity utilizing ALCOA+ Principals
• Compliance with 21 CFR Part 11 and GAMP 5 Current Requirements
• Periodic Review Program / Continuous Monitoring