As highlighted in my previous blog on Batch Release in the Life Sciences Industry – Challenges and Imperatives; we at Infosys understand the criticality of stringent quality control in the life sciences industry. With extensive experience in this constantly evolving sector, we have developed an end-to-end solution leveraging SAP Business Technology Platform (BTP) to help expand efficiencies and address the challenges in the batch release process.
Infosys’ fully functional Batch Release Cockpit facilitates batch release across a wide range of business scenarios including incoming inspection, in-process inspection and final inspection. It can monitor information related to deviations, incoming components, quality control tests, release-relevant material restrictions, open quality notifications as well as material components listed in the batch genealogy.
A persona-based cockpit, it enables users to view information relevant to their individual functions. Users can also leverage persona-based dashboards for status monitoring. Some of the standout features of our batch release solution are:
- Batch release after incoming inspection, preceded by technical release in procurement
- Market release to distribution hubs
- Distribution release of the finished product
- Quality certificates including certificates of analysis and certificate of conformance
- Single-screen batch release with provision for results recording
- In-built integration with SAP S/4HANA, facilitated by Infosys developed APIs
The solution provides for updates on batch characteristics and reviews on batch genealogy, optimizing the overall production flow. Further, quick and easy access to data for batch verification and automatic rule-based checks help reduce human error.
Benefits:
The solution accelerates the batch release process and automates time-consuming verification activities. This helps reduce non-compliance and risk management costs, bringing in much-needed uniformity and standardization. It enhances the overall quality of release cycles, thereby reducing market complaints.
The solution helps improving business KPIs like quality release cycle time, order fulfillment lead time, number of batch releases pending, number of batch recalls, number of batches for which raw material is dispensed for production.
Navigating the Next:
The robust batch release cockpit solution offers life sciences companies a user-friendly, intelligent solution, bringing all batch-related information on a single platform. Its key drivers are automation, higher accuracy in batch usage decisions, enhanced operational efficiency, and shorter batch release cycle times.
But that is not all. The solution also brings with it opportunities for greater technological advancement with enhanced capabilities. Subsequent phases of the batch release cockpit will include the integration of third party applications such as 3PL/MES/LIMS and for real-time information receipt. Integration with cold-chain data and time out of refrigeration (TOR) will help with timely monitoring and intervention in instances of Time Out of Refrigeration (TOR) breach. Integration with Corrective Action Preventive Action (CAPA) subsystem will assist in preventing and addressing quality concerns. Enabling batch release process workflows will ensure an optimized production flow. The real time integrations and interventions will help to improve overall governance and accelerate the business processes and drive faster growth.
