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A cloud-based system that enables swift and flexible process improvements.
Yokogawa Electric Corporation announces the release today of OpreX™ Quality Management System, a product in the OpreX Operational Risk Management family.
OpreX Quality Management System is a cloud-based system that can accelerate the digital transformation of quality assurance processes for the manufacturing of pharmaceuticals and food & beverages. It streamlines operations and allows for continuous improvements by enabling the tracking and centralized management of quality assurance processes such as the handling of deviations from manufacturing procedures and specified standards, implementation of CAPA*1, changes to manufacturing procedures, and revision of documents.
Development Background
In addition to taking steps to ensure swift compliance with GMP*2 and GQP*3 standards and enhance quality assurance processes, the pharmaceutical manufacturing industry has been looking to streamline operations and reduce costs.
At the same time, quality assurance with the production of pharmaceuticals and food & beverages involves a broad range of processes that include dealing with deviations, implementing CAPA, and managing any necessary changes to manufacturing procedures, so smooth and correct management of these processes is a necessity.
Main Features
1. No-code workflow building for flexible improvements to quality assurance processes
The need to code workflows for handling deviations, implementing CAPA, changing manufacturing procedures, revising documents, creating education records, and other such processes is eliminated, enabling the flexible programming-free handling of a wide variety of quality assurance processes.
2. An advanced platform enabling the addition of functions and linkage with other systems
This product is a cloud-based system built on the globally proven, flexible, and highly scalable ServiceNow® platform. With this platform, updates for new functions can be performed swiftly.
Furthermore, as a standard feature, a variety of connectors are provided for linking to manufacturing execution systems, laboratory information management systems, and the like. This reduces the time and effort required to integrate the handling of data by different systems, and the likelihood of human error, thus enabling the precise and efficient execution of quality management operations.
3. Contribution to data integrity through compliance with rigorous regulatory standards
The audit trail and user management methods employed by this system comply with global pharmaceutical regulations, leading to improved integrity in the handling of data for quality assurance processes. This product uses the latest security protocols that comply with the standards of the International Standards Organization, thus enabling robust security.
*1 Corrective and Preventive Actions. An efficient and systematic process for eliminating defects and non-conformities by identifying causes and taking steps to prevent their recurrence
*2 Good Manufacturing Practice. A set of regulations on manufacturing management and quality control for the pharmaceutical industry
*3 Good Quality Practice. A set of regulations on quality control for pharmaceuticals, quasi-drugs, cosmetics, and medical devices
Major Target Markets
Pharmaceuticals, food & beverage, chemicals
Applications
Quality assurance process management
About OpreX
OpreX is the comprehensive brand for Yokogawa's industrial automation (IA) and control business. The OpreX name stands for excellence in the technologies and solutions that Yokogawa cultivates through the co-creation of value with its customers, and encompasses the entire range of Yokogawa's IA products, services, and solutions. This brand comprises the following five categories: OpreX Transformation, OpreX Control, OpreX Measurement, OpreX Execution, and OpreX Lifecycle. One of the product groups that make up OpreX Transformation is OpreX Operational Risk Management, which includes the OpreX Quality Management System. With its various OpreX Transformation solutions, Yokogawa is able to quickly effect changes for its customers that lead to a transformation in such areas as management and operations, and provides highly reliable control technology that ensures high efficiency, high quality, and safe and stable plant operations.
About Yokogawa
Yokogawa (yokogawa.com) provides advanced solutions in the areas of measurement, control, and information to customers across a broad range of industries, including energy, chemicals, materials, pharmaceuticals, and food. Yokogawa addresses customer issues regarding the optimization of production, assets, and the supply chain with the effective application of digital technologies, enabling the transition to autonomous operations.
Founded in Tokyo in 1915, Yokogawa continues to work toward a sustainable society through its 17,000+ employees in a global network of 126 companies spanning 60 countries.
The names of corporations, organizations, products, services and logos herein are either registered trademarks or trademarks of Yokogawa Electric Corporation or their respective holders.
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