How PCI reduced validation labor hours by 65%

Pharmaceutical Calibrations & Instrumentation LLC (PCI) needed to improve efficiency in commissioning, qualification and validation of temperature-profiling equipment for pharma/biotech clients, including one of the world's largest biotech companies. PCI evaluated multiple systems and chose Kneat for its 'ease of use, robustness, and flexibility to accommodate any GxP process and scalability.' Results: a 65% reduction in labor hours and costs per chamber, with average labor hours per GMP chamber dropping from 26 hours to 9 hours. A PCI project leader said: 'Our partnership has helped to deliver digitized validation to one of the largest biotech companies in the world.'

Kneat is a paperless computer-system and process-validation platform — one of the two dominant players in digitizing the validation evidence GxP systems require before go-live.

This sits in the Ship stage of the AI use-case lifecycle: Named examples from the vendors pharma teams use to get an AI system live inside a real, regulated production workflow — validation, CRM, safety and clinical systems of record.