Logsheet System Implementation at API Facility

This project focused on resolving critical documentation and compliance gaps identified during an internal audit of Promega’s new AP/ manufacturing facility. The primary objective was to design and implement a standardized, QA-managed logsheet issuance system that replaces uncontrolled, loose documentation with serialized, traceable, and compliant records. This system strengthens data integrity, ensures alignment with FDA 21 CFR Part 211 requirements, and prepares the facility for future electronic documentation processes. Ultimately, the project restores audit compliance, enhances traceability, and establishes a more robust and sustainable documentation governance framework.