Seeking Singapore Partner - Real Time Batch Tracking in Pharma/Med-devices/Food

Supply chains are global, complicated and fragmented. Communicating, collaborating, and securely sharing info across geographies, timezones, languages, and cultures is extremely challenging.

The OneSC platform enables customers to streamline data collection and fast-track batch approval through an intuitive AI-driven cloud platform. Once embedded, our customers see their OPEX drop by up to 30% and increase productivity. Our focus initially is the pharma industry followed by other regulated industries like med-devices, food, cosmetics etc. Further info on OneSC - Cloud Platform For End-To-End Pharmaceutical Batch Tracking​ .

Pharma Regulatory standpoint: Pharmaceutical organisations are legally required to keep accurate and fully auditable batch records from manufacturing to market release to meet regulatory requirements. These records must account for any risk-based decision making and the supporting evidence available/generated at the time. The regulation ensures that healthcare products are safe, effective and of high quality, and organisations need to prove they comply with transparent and traceable documentary evidence. OneSC helps you meet this obligation through an intuitive interface which seamlessly integrates into the ecosystem.

Medical Devices Standpoint: Similar to drugs and medicines, medical device manufacturing and distribution are governed by Medical Device Regulation (MDR) 2017/74, where manufacturers & distributors must demonstrate compliance with regulatory requirements. This must be evidenced through detailed documentation explaining how the device was manufactured, what raw materials were used, and how it was tested and distributed to ensure the highest product quality, holding patient safety at the core.

The GAMP-validated OneSC platform ensures regulatory compliance by establishing an immutable single source of truth, offering fully traceable and easily demonstrable interlinked data, records and bookmarks within a record.  Once the platform is embedded, the risk of releasing product batches with incomplete or inaccurate data is significantly reduced due to engineered controls, and customers can meet their market supply obligations to avoid fines. The platform ensures the QP has the correct information in one place at the right time for an efficient batch review and release, protecting the business from delays and costly fines. Failure to have the proper information delays batch review and release or incorrect batch approval, penalising the QP and organisation. All communications are fully auditable and in compliance with data integrity regulations.