Strategic Compliance and Quality Management
Our client is a young and quickly growing company with many new employees joining every month. Their processes are not yet fully implemented, and the environment requires quick reaction, positive creativity, and a high qualification expertise. The daily routine is intertwined with production planning, and any irregularities must be solved quickly. Finally, the high fluctuation requires a clear communication strategy and proactivity to get everybody on board.
Arcondis naturally grew with the client, and our consultants now work as trusted advisors. We got there by meeting the client’s team face to face, ironing out the processes and enjoying successes together. We simplified the qualification guidelines by removing daily use machinery from a standalone qualification and instead focused on less obvious but nonetheless vital production machinery.
Ultimately it is about enabling our client to produce important medicine. Qualification is one of the key success factors. Routine production and clinical production have to work for the client and need to be part of the QM systems.
Accompanying our client on the road to smart commercial production.
Setup of a holistic qualification process
Ensuring all client team members are on the same page and working toward a common goal
Optimizing the client’s organization to ensure a clear division of tasks