Special Recognition: Phil Jarvis of BioMarin for his review and guidance of this case study
This paper outlines the business process changes that achieve a simplified more streamlined risk-based Commissioning, Qualification and Verification (CQV) process and how the application of an electronic CQV technology will embed this lean methodology across your organization, enabling a structured repeatable process that increases productivity and enhances compliance for years to come.
It details the rewarding outcomes that one can expect based on successful industry deployments - a lean cross-site harmonized process delivering productivity, reduced cycle times, compliance and data integrity benefits.
The new automated process provides a compliant, productive, simplified ASTM E2500 methodology with early-on issue identification and real-time information/data access together with status tracking, schedule cycle-time assurance and project documentation change management.
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