Pharmaceutical is one of the highly regulated industries in the world. Balancing safety, regulatory compliance, quality and efficacy of the final drug is a continues challenge. Missing out on any of this will result in huge cost implications and an irreversible damage for the brand.
Process mining is proving to be an powerful tool in demystifying the complexity of pharmaceutical operations. Change control process is one of the most common process used to implement any change which can influence the safety, quality or efficacy of the drug. Multiple departments like regulatory, production, safety and quality is involved in closing a single change control process.
Change could be due to a machinery change in production or regulatory or quality issue or anything else. Every change request at first should be assessed for risk like safety, regulatory or efficacy. Only when the assessment is passed the change would be accepted for implementation. After the implementation of the change we need to measure the effectiveness based on this either we would close the change request or recreate a new change request.
Process mining on change control process shows how the process is executed in the real world. Why is there a delay in closing the change request. Why the actual execution do not follow the defined process.
In a medium sized pharma companies typically 1500 people are involved in change control process including people from regulatory, production, safety and quality. It was concerning for the company to see how many man hours and resources are tied up in the change control. The volume of change requests created was increasing over time and it was impossible to understand the reason for long cycle times manually.
Process mining proved to be the ray of hope. Process relevant data like Case ID, Activity and Timestamp are captured from Quality Management System (QMS) to start process mining. Knowledge models are built internally by monitoring real time behaviour of your execution which would be the basis for all insight from process mining.
As part of the insights you will know why your process are stuck for long time or what makes the whole process inefficient. The biggest benefit is the insights generated are real time and the platform gives you the possibility to make corrective actions in real time before it too late giving you a chance to take needed actions to get your process execution back on track.
Its impossible for a human to understand and make sense of the huge amounts of process data generated. Process mining automates this task and gives you the opportunity to steer your process in the needed direction.
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