The audit prioritized four critical areas: raw material tracking, equipment maintenance, data management, and the handling of biological samples. Auditors examined the entire lifecycle of materials, verifying that record-keeping connects specific inputs to final products. Equipment oversight was assessed through qualification logs, calibration certificates, and maintenance history to ensure consistent production standards.
Digital oversight formed a significant portion of the inspection, specifically regarding the security and validation of systems like Core-System and U8 Cloud. Tsingke utilized this review to demonstrate how standardized workflows support its broader 'Gene Factory' model. By integrating digital technologies with molecular manufacturing, the company aims to move beyond isolated production steps, instead optimizing the entire manufacturing chain. These established quality controls serve as the technical foundation for applying artificial intelligence to process monitoring and future manufacturing scalability.
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