The third pilar of EDaM assures that each production batch is equivalent to any other batch in terms of quality, thus anticipating compliance with PQLI (Product Quality Lifecycle Initiative) on continuous process validation. Lean thinking and tools are used throughout process/product lifecycle to further reduce process variability.
Thanks to our EDaM integrated approach, feedback will be given to the “Screening” and “Industrialization” functions to allow for continuous process optimization.
In addition, a comprehensive manufacturing management system is in place that can compute all aspects of process/product cost structure involved in the manufacturing stage.
Lean Supporting Tools
- Lean 6 Sigma
- Statistical Evaluation