In life science biopharma manufacturing, demonstrating consistent, repeatable processes is essential both for regulatory compliance and product quality. Being able to create data-driven, performance-based objectives, and aligning the process control strategies with compliance and business performance objectives, allows companies to take their data analysis to the next level: the level at which it becomes meaningful for the company’s bottom line.
When it comes to continuous quality improvement and removing defects from a process, Six Sigma continues to be the gold standard in manufacturing and process management. This structured, data-driven methodology for discovering problems relies on rigorous analysis of production and process data. For many companies, engaging in a Six Sigma process can be time consuming or even a bit daunting.