Yokogawa Electric Corporation announced the October 23 global release of the OpreX Environmental Monitoring System for the pharmaceutical and medical device industries. The new product is a data collection and recording system that records and manages environmental data, such as temperature, humidity, and room differential pressure in pharmaceutical and medical device manufacturing, testing, and storage areas. This system makes use of Yokogawa paperless recorders that comply with Good Manufacturing Practice (GMP), Quality Management System (QMS), and other regulatory requirements and are installed at multiple locations around a plant. The new system reduces risk and aids pharmaceutical and medical device manufacturers in the performance of strict and efficient environment monitoring that ensures compliance with the various regulations and guidelines on operations at manufacturing sites.
This system consists of Yokogawa paperless recorders, a data server, and monitoring PCs. Key features include:
- Compliance with regulatory requirements
As required by the FDA's 21 CFR Part 11 and other electronic recording and signature regulations, the following functions are provided with the OpreX Environmental Monitoring System: a user management function, a function that prevents the rewriting, deletion, or falsification of recorded data files, an audit trail function, a time synchronization function, a backup restoration function, and an archive retrieval function. This ensures that the recorded data is correct, comprehensive, complete, and stored securely.
- Data collection and long-term storage
This system's paperless recorders can be installed at multiple locations around a plant, reducing the risks that come from having all data stored in one central location. The data from the recorders is stored on a highly secure data server using a file format that helps prevent and detect any tampering of data. For backup storage, each recorder is equipped with an SD card function. In response to requests for data by auditors or other individuals, users need only to access and provide the relevant file.
- Real-time monitoring
If a data error is detected by a monitoring PC, the PC will display an alarm message, issue an audible alarm, and/or send an email, depending on the paperless recorder setting. In addition, the data that has been collected by a paperless recorder can be accessed from any web browser.
- Computerized System Validation (CSV)
The paperless recorders, data server, and monitoring PCs used in this system undergo a CSV assessment that complies with GAMP5, a de facto global CSV standard, before shipment to the customer.