The primary goal of regulatory authorities is to protect public health. One of the ways they do this is to inspect regulated facilities to ensure they comply with regulations.
When one of our customers received a number of observations after an inspection by the Swedish Medical Products Agency, naturally, they wanted to react quickly.
However, as a small company with similar operations across three facilities, it was important to take a lean quality approach, i.e. to achieve optimal results using the least amount of resources possible.
Using a CAPA approach, PlantVision helped to investigate the root cause of problems and to define process goals. This enabled the current situation, as well as the future desired situation, to be mapped. Implementation, with specifically timed activities were then planned, carried out and validated efficiently.
The project delivered a clear description of a standardized way of working, with a formal road map for change and a common set of instructions for all three facilities.
It also resulted in smarter operations!
- Identification and correction of root cause
- Improved processes and routines
- Removal of unnecessary steps
- Harmonized operations across facilities
- Increased knowledge of GMP guidelines and regulations
- Enabled a clearance from authorities – ‘License to Operate’