Pharmaceutical firms around the world are facing enormous pressure in terms inflation, energy costs, labour shortage, regulatory, quality, price. Given the complexity of drug manufacturing process its a continues challenge to balance safety, quality, regulation, efficacy and quality of the final drug. On top of this external pressure are stressing out the entire industry.
One of our German pharmaceutical client has taken an innovative approach in this challenging times. Being one of the top pharma CDMO in Germany the focus was on improving productivity and efficiency in the current environment. However, the biggest question was what has to be optimized or improved. Where should we focus to gain the most results.
At Oitro, we were able to solve this as we believe the answer lies in your operations. Our client had couple of big questions like why dose it take so long for quality team to close change control process. Where do we get stuck or how can we improve efficiency and close pending activities faster.
We employed an advanced and new data science techniques called process mining. We collect siloed process events from various IT systems like Quality Management System (QMS), Regulatory Information Management (RIM), Production (SAP) and start process mining on this data in real time. We then visualize how your change control process is executed in real world and identify all the root causes for its variation from the defined process flow.
Our Action Flow engine gives us the possibility to intervene and trigger actions in real time whenever a concerning variation is found. This not only shows us the problem but gives us the possibility to take actions before the problem gets bigger or goes unnoticed.
Our client was surprised to see how many man hours of its qualified team from regulatory, production, quality are wasted due to siloed way of working. Due to this quality team took very long cycle times to close their change control process. Each time the root causes are different.
Some time it was due to delay of risk assessment from production, incomplete information for regulatory department, missing of some crucial process steps,. Etc. Individual action flows or automation bots could be programmed for each category of root causes to ensure your process remain compliant and efficient in all cases and overall productivity and synchronization between multiple departments is improved in real time.
Our client could not only achieve the needed results through process mining but also found new avenues for improvements which was unseen so far. They have a strong commitment to bring more and more process to our SaaS platform and unlock new value proposition.
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