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CrossLab Computer System Validation

CrossLab Computer System Validation

All computer systems—including hardware and software—must be fully validated to support the data generated for submission to regulatory agencies. Specifically, systems need to be validated for their “intended use,” application/method, and environment to be considered compliant. In addition, CrossLab Computer System Validation (CSV) is the foundation for Data Integrity compliance which is the main focus of regulatory audits and warning letters issued by the FDA.

You can efficiently and cost-effectively validate your computer systems by partnering with Agilent. Our experts can help assess your overall risk, streamline validation by focusing on high-risk areas, and comply with regulatory guidelines and regulations:


  • • Good Automated Manufacturing Practice (GAMP®5), including the risk-based approach and V model documentation
  • • US Food and Drug Administration (FDA) 21 CFR Part 11 for electronic records and signatures

Validation is a lifecycle process that includes new system commissioning, change control for system upgrades/relocations, and decommissioning systems for archival. Agilent supports your lab every step of the way with these CSV services:


  • • Audits/assessments
  • • Generic validation documents (Starter Kits)
  • • Custom validation development (Consulting)
  • • Validation execution - Installation and Operational Qualification (IQOQ)
  • • Reduce your CSV time by up to 50%

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