Good Manufacturing Practice (GMP) regulations require that companies maintain minimum standards for processes, equipment, facilities and quality management systems. However, it can be challenging to accurately record and track various data streams in real time, within manufacturing facilities.
A panel of industry experts recently gathered in a round-table style webinar to discuss the importance and challenges of data integrity in a GMP environment, the methods by which digital lab assistants maintain data integrity, security and audibility and how digital tools can facilitate real-time data-driven decisions and improve quality management.
“Protocol adherence often comes up during investigations as root causes for an out-of-specification result. Operators can’t always remember multiple experimental protocol steps for several hours and then write them down accurately after the fact."