Computerized Systems & Validation
Risk-based validation and assurance of computerized systems supporting regulated processes, including CSV, CSA, electronic records, data integrity, and 21 CFR Part 11 compliance.
Capabilities
Modern regulated operations depend on computerized systems to generate, process, maintain, and report critical quality and manufacturing data.
N&CS provides consulting support for computerized systems and electronic records, including:
Our approach is designed to help organizations establish confidence in the reliability, integrity, and intended use of computerized systems supporting regulated processes.
Where this fits
N&CS connects this capability with regulatory compliance, quality, validation, engineering, manufacturing and project execution within a broader life-science consulting model.
Quality-led delivery
We apply a quality-first approach to every project—from engineering and validation to manufacturing, regulatory compliance, and remediation.