Paperless Qualification Program

CHALLENGE

This project involved a pharmaceutical manufacturing company managing a paper-based qualification program across many sites. On an annual basis, they generate almost 1000 protocols, executions, reports, and investigations as part of their qualification processes. The team also uses over 100 different types of Qualification/Periodic Review templates.

HOW WE HELPED

Cheme Engineering worked collaboratively with a validation software company Kneat to deploy a unique cloud-based solution called Kneat Gx. The qualification process is now digitalized from end-to-end, enabling the creation, review, and execution of paperless qualification documents. This new process enables real-time collaboration during document review and execution. Compliant documents are produced while cycle times and Good Document Practice (GDP) errors are reduced- if not eliminated completely. It adds up to increased efficiencies and optimized resources across the sites

CUSTOMER’S SUCCESS

Since the project was completed, the organization has seen the following improvements to their CQ process. The project:

• Eliminates the need for paper and Is easier, faster, and smarter
• Creation of the protocols takes ~50% less time
• Real time collaboration can be performed in every stage
• Reduced time to execute validation documents
• Reduced waste printing, binding, and storing of paper documents