Biogen’s Cambridge Manufacturing Facility leaders assessed their paper-based SOP delivery system. Their findings were that their procedures were inefficient and costly.
Inherent in a biotechnological and pharmaceutical manufacturing facility is a constant cycle of change, as well as the need for utmost control over the changes. Because the Standard Operating Procedures (SOP) are so crucial to the success of a product, there must be strict controls around the recording, storage, and communication of any modifications in the manufacturing facility. This case study focuses on how Biogen improved the delivery of critical documentation by leveraging BIOVIA Quality and Regulatory Compliance Management Software on Apple iPads.