Enhancing Quality And Environmental Monitoring Efficiency Through Paperless Sampling

By Jiwoon Kim, Lead Manager, Quality Execution System; Neulbit Kim, Senior Scientist, Facility Monitoring; and Hyeonjung Park, Senior Scientist, Facility Monitoring

At approximately 600,000 environmental and utility monitoring samples per year, the documentation burden of paper-based sampling is not just an efficiency problem; it is a compliance risk. Manual transcription errors, unreliable audit trails, cleanroom contamination from paper forms, and limited data retention capacity all represent vulnerabilities that grow with operational scale.

This whitepaper, authored by quality execution and facility monitoring specialists Jiwoon Kim, Neulbit Kim, and Hyeonjung Park, details how a fully integrated digital sampling system addresses these risks through ELN-based documentation, LIMS integration, remote APC operation, and automated audit trail generation in support of 21 CFR Part 11 requirements. The paper also examines the technical complexity behind implementation, including the development of approximately 822 APC interfaces, wireless infrastructure upgrades, and a phased rollout strategy, and situates the initiative within the broader trajectory toward Pharma 4.0.

Explore the research to see how the outcomes compare to what was anticipated.