Summary
This technical report outlines the challenges faced by a global Contract Development and Manufacturing Organization (CDMO) in the manual review of batch records. The company processed over 10,000 batches annually, which required extensive manual reviews leading to lengthy release times of 7-10 days, significant error rates, and a heavy resource burden. To address these issues, the report details the implementation of tailored machine learning models that automate the review process, embedding validation rules to ensure compliance. The shift to a review-by-exception model allowed quality teams to focus on deviations rather than every entry, resulting in a 60% reduction in review time. The report emphasizes the impact of these changes on efficiency, compliance, and supply chain reliability, highlighting the importance of intelligent automation in modern manufacturing processes. Overall, the implementation led to faster product release cycles and improved data accessibility for analytics.
