Observation Index

The Observation Index, developed by i-Solutions, has been integral in organizing, structuring and executing compliance projects and programs. The tool captures existing and new audit observations from multiple sources (agencies, customers, vendors, or internal organizations) via electronic data transfer or manual entry. The captured data provides seamless traceability to source documents. The Observation Index is configurable and customizable to facilitate classification and grouping of observations into well-defined categories. It also has the capability to identify duplicate and similar observations. The Observation Index is designed to integrate with CATS® as corrective actions are assigned to observations. Providing one source of truth for tracking the life cycle of an observation (identification, remediation, verification, and certification) is a key element of the Observation Index.


Related pages:
     •  Manufacturing Operations
     •  Research & Development
     •  Regulatory Compliance
     •  Project Management
     •  Operations Improvement