The certification enables pharmaceutical companies to seamlessly connect in-process control (IPC) test data with their MES – a decisive step towards true paperless manufacturing and complete data integrity. With q-doc®, results from multiple IPC tests performed at different manufacturing steps can be centrally captured, managed, and automatically sent to the MES. This brings test results from raw material powder characterization (e.g., untapped and tapped bulk density or particle size distribution) to final dosage form testing (e.g., tablet hardness, friability, loss on drying, weight, dimensional measurements, water activity, visual inspection) directly into a production context, simplifying processes and increasing compliance.
“q-doc® from SOTAX is a perfect addition to our ecosystem of technology partners. The joint interface between both solutions creates an end-to-end connection between laboratory and production data – supporting our customers in meeting regulatory requirements efficiently and digitally,” says Lars Hornung, Senior Principal Alliances & Technology Partners Software at Körber Business Area Pharma.
q-doc® is modular by design and supports more than 20 different tests usually performed in IPC and QC, as well as over 35 different types of instruments from SOTAX and other leading brands. Its powerful device-independent data structure provides comprehensive, yet simplified batch reporting with built-in regulatory compliance and standardized reporting for all essential IPC tests. Intelligent features such as barcode support, LDAP integration, data trending or batch comparison allow to further streamline lab operations and associated data management tasks.
“The new standard interface between PAS-X MES and q-doc® allows customers to realize significant efficiency gains through elimination of the data transcription burden between systems, thus facilitating an accelerated batch release”, says Rui Fraga, Product Manager for q-doc® software at SOTAX. “We are proud to be an official technology partner of Körber. Our companies often share the same customers who can now advance towards a true Electronic Batch Record (EBR) with this digital bridge between our respective software solutions.”
