Yokogawa Releases OpreX Quality Management System To Accelerate DX in Quality Assurance Processes for the Manufacturing of Pharmaceuticals and Food & Beverages

Yokogawa Electric Corporation (TOKYO: 6841) 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.