Case Study

Identifying Operational Improvements For Batch Records And Quality Assurance

Source: CAI
Engineer Teaching Apprentice GettyImages-483571473

The critical issue this mature client faced was a timely product release. While release delays prevented them from reaching organizational and financial goals, the product was on the FDA’s Drug Shortage List, which raised the stakes and increased the urgency for production and release. The client had an idea of where they needed to improve and brought CAI in to help with specific issues. CAI's team of experts captured and analyzed batch data to identify areas where the client’s established process and communication flows prevented them from viewing the entire scope of challenges. Their areas of concern were a part of the overall problem, but they were unable to view the “big picture” to realize the process and organizational issues that needed to be addressed.

Learn how CAI helped the client reduce their batch record backlog, minimize their manufacturing error rate, sustain timely productivity and release levels, meet FDA commitments, and achieve an impressive monthly financial return.

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