Robotic process automation (RPA) can help the pharmaceutical industry improve efficiency, quality, compliance, and innovation by streamlining various processes across the value chain. Validation is one of the key challenges that must be addressed before robotic process automation can be widely adopted by pharmaceutical companies. In a regulated environment, any system that performs a decision-making function should be validated, and a solid change control process should be put in place. RPA systems seem to have the potential to effectively meet these requirements because they are configurable, auditable, and specifically designed to perform exact same process “time and again”.
Here are some of the use cases from clients in pharma industry:
Reporting and compliance: RPA automated the generation and submission of regulatory reports, such as adverse event reports, periodic safety update reports, and clinical trial reports. Automated processes also monitor and validate the data quality and accuracy, ensuring compliance with the standards and regulations of different authorities and markets.
Electronic Batch Record Review: Bots are used to perform batch record review activities, ensuring that all the documentation needed is actually included and that information collected from different systems involved in the process is coherent and within operational parameters of defined SOPs.
Pharmacovigilance: Automation bots are helping with collection, analysis, and dissemination of information on the safety and efficacy of drugs. It help with reducing the manual effort and human error involved in pharmacovigilance activities, such as case intake, data entry, triage, coding, assessment, and reporting.
Clinical trials: Implemented bots are assisting with management and coordination of clinical trials, such as patient recruitment, screening, enrollment, consent, randomization, data collection, monitoring, and reporting. It has also improved the quality and reliability of clinical trial data, as well as the speed and scalability of clinical trial operations.
Supply chain and inventory management: Automation processes are assisting with planning, execution, and optimization of the supply chain and inventory processes, such as demand forecasting, order processing, shipment tracking, inventory replenishment, and invoice reconciliation. Its assisting the team with enhanced visibility and traceability of the supply chain and inventory, as well as the compliance with the good manufacturing and distribution practices.
Financial Record-Keeping and Reporting: This is most commonly acceptable area for automation solution providing streamline data workflows, data verification, and scheduling during account reconciliation and reporting of transaction data, eliminating the manual scheduling of jobs in the backend, ensuring GxP compliance, and making it easier to manage tax and legal activities with high level of accuracy and in much optimized duration.
In the highly regulated pharmaceutical sector, RPA solutions can enable organizations to comply with regulatory guidelines while taking full advantage of automation and innovation. Furthermore, RPA can decrease labor costs, reduce the time spent by employees on repetitive and noncore tasks, and reallocate users to higher value-added activities. In a nutshell, adopting RPA helps pharma companies bring safe and effective drugs to market in a shorter time and at a lower cost.
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