The Role of Quality Control in Biopharma Lab Operations

Quality control (QC) serves as the vital heartbeat within the dynamic realm of biopharmaceutical laboratories. Beyond ensuring adherence to rigorous regulatory standards, QC emerges as a central player in continually enhancing laboratory operations and the meticulous collection of essential data. This pivotal role involves maintaining compliance and contributing significantly to the overall efficiency, reliability, and quality of processes within biopharma lab operations. By upholding rigorous quality standards, QC becomes a cornerstone for fostering excellence, reliability, and precision in pursuing innovative solutions and developing safe and effective biological medicines.

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LabWare® has achieved the “Ready” level required to join Körber's Ecosystem of partner companies.

With that, the two companies are taking the seamless integration capabilities between LabWare’s LIMS (Laboratory Information Management System) and Körber’s PAS-X MES (Manufacturing Execution System) to a new level of cooperation.

Körber's collaboration with LabWare marks the next milestone following the launch of Körber's "PAS-X LIMS Integration" program, a new element within the Körber Ecosystem. This program offers customers improved convenience in identifying LIMS suppliers compatible with PAS-X MES. It demonstrates to customers that Körber and its partners can significantly reduce the effort and risk involved in integrating LIMS with Körber's world-leading Manufacturing Execution System PAS-X MES by using a standardized interface. 

LabWare, a trusted partner to most of the top 25 global pharmaceutical companies and a worldwide leader in laboratory informatics, brings profound expertise and operational excellence to this relationship. “Our LIMS is used at more than 29,000 laboratories with more than 150,000 daily users and a billion samples tested a year,” says Mark Gonzalez, Technical Director at LabWare. As a certified partner, LabWare demonstrates seamless integration capabilities with PAS-X MES. “The successful collaboration between LabWare and Körber has already greatly benefited our shared customers over the years,” Gonzalez adds. 

The integration of MES and LIMS has emerged as a pivotal component in the digital transformation journey within the pharma and biopharma industry, especially given the laboratory's critical role in the overall production and supply chain processes. Lars Hornung, Senior Principal Alliances & Technology Partners Software, Körber Business Area Pharma, elaborates: “For instance, as part of the manufacturing process, PAS-X MES triggers a sample request to the LIMS, and the LIMS communicates detailed sample data back to the MES, enabling efficient label printing for each sample. After sample collection, PAS-X MES sends a sample confirmation to LIMS, including additional information for Quality Control (QC) purposes. The laboratory conducts the tests, and LIMS manages the results, which are then transmitted back to MES for further processing. Therefore, seamless integration between these systems is vital to streamlining processes and eliminating human error.”