Your background
Faced with increasing strict regulations, Quality Control laboratories must endure growing pressure from health authorities (FDA, EMEA, MHWL (Japan)) with respect to Quality Control processes. They therefore must be able to deal with increasingly long quality control processes, which lengthen product cycle times and slow down product release, resulting in higher inventories.
Your constraints
- Laboratories do not produce enough certificates to keep up with production
- Laboratories have problems with processing all the new approval requirements related tests and clinical tests and with increasingly frequent new product introductions
- Late tests are on the rise
- Quality Control costs continually increase without a clear productivity vision