Change Control Process is one of the critical process in pharmaceutical industry. In a large pharmaceutical company on a average there are around 40000 changes evaluated in a year out of which 15000 changes are agreed to be implemented after initial assessment. Typically, there will be around 200 changes for a single product in a year. It takes around 6 months to 2 years to close some of the change control process.
lets take an example of a change request created by production they would like to change part of their bioreactor for better efficiency. This change request need to assessed for impact on drug safety, quality, regulatory aspects. Once, all of the concerned departments have given the green light the change request is accepted for implementation. Validation on the effectiveness of the change is checked to ensure there are no surprise at the end.
As you see a single change request involves synchronization between multiple departments any miss interpretation, incomplete information or skipping of any process steps would result in the process getting stuck or rework needs to be done resulting in inefficient process execution hence increasing the cycle time. Resulting in reduction in productivity and wastage of resource utilization.
This kind of detailed real time insights was unseen in the pharmaceutical industry and process mining is opening door to such details giving a clear picture of how change control process is executed in the real world. We also have the possibility to trigger automation or actions whenever such variations are detected to stop clogging of the execution.
With process mining you are in full control about the execution of your process in real time and ensure your process remain efficient thereby improving the overall productivity of the underlying process.
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