Top Clean Injection Labeling Process Validation Case Study

This case study details the implementation of LABEL ARCHIVE and IQ/OQ/PQ documentation at Top Clean Injection, a subsidiary of Top Clean Packaging specializing in medical device manufacturing. The document outlines the challenges faced by Top Clean Injection, including a manual multi-step label approval process and compliance with stringent US and European standards. It describes the solution provided by TEKLYNX, which included the integration of CODESOFT and LABEL ARCHIVE software to enhance label management and validation processes. The results of this implementation are highlighted, showing significant improvements in label approval workflows, traceability, and compliance readiness. The case study emphasizes the reduction in validation time from weeks to just 1.5 days, demonstrating the efficiency gained through the use of TEKLYNX's Validation Accelerator Pack. Overall, the document presents a comprehensive view of how Top Clean Injection achieved compliance and improved operational efficiency in a highly regulated industry.