
Pharmaceutical and biotech companies must comply with various market-specific anti-counterfeiting requirements, such as GS1 standards, Russian crypto codes, Chinese NMPA, FDA, EMA, and more. They need to globally serialize their products and manage the associated complexities. New packaging lines and legislative changes must be incorporated flexibly. Security gaps shorten the support cycles of IT systems and present a challenge to keep the system up to date and validated with minimal effort.
PAS-X Track & Trace V3 addresses these challenges, featuring advanced technology with automatic scaling, optimized deployment procedures, and centralized system operation. Its cloud-based design allows it to run on-premise, in the customer's cloud, or fully managed by Körber as Software as a Service (SaaS), fitting into any company's business strategy. Körber provides continuous support to keep the system up-to-date, along with an optimized validation approach that significantly reduces customer efforts for revalidation.
“PAS-X Track & Trace ensures compliance with regulatory standards while boosting operational efficiency. The latest version is a lean, functional complete and cloud-native solution designed to simplify daily operations and enable digital transformation as part of broader company strategies. Customers benefit from reduced total cost of ownership (TCO), comprehensive lifecycle management, and a future-proof software solution that aligns with their long-term IT strategy,” says René Reuter, Product Owner Software at Körber Business Area Pharma.
The serialization solution serves as a vendor-agnostic site manager and harmonization layer between site and enterprise systems, seamlessly integrating packaging lines, MES and ERP systems, as well as serial number repositories from any vendor through standardized and configurable interfaces. It can be quickly implemented with reduced qualification requirements due to its configurable integration into existing business processes and fully qualified out-of-the-box standard product design.