Environmental Monitoring Compliant with Pharmaceutical Regulations
The OpreX™ Environmental Monitoring System collects, measures, and stores temperature and humidity as well as other management data for comprehensive oversight of the pharmaceutical manufacturing, quality control, and storage areas.
Major features
Data Integrity
- Meets ALCOA+ requirements
Data Collection and Long-term Storage
- Long-term storage of collected data in recorders that are FDA 21 CFR Part 11 compliant
Real-Time Data Monitoring
- Monitor measured data and alarms using the monitoring software
Centralized Management for Login User
Centralized management of user names and passwords using servers on the network is possible through Active Directory.
- Centralized management of user name/password in Data Server and recorders
- User login access control
Data Management
- Integrated management of data collected by multiple recorders
Packages
Data Management Package
Centralized management of the recorded data file
Access Control
Users are assigned to groups and are given access privileges based on the group they belong to.
Only authorized users can login to the system and search and browse through data.
Audit Trail Function
All operations on records（Backup/Restore/Archive/Delete etc.）by an authorized and logged-in user are automatically recorded and saved in the audit trails. Data server and recorder audit trails are listed. The recorded audit trail can be downloaded as a PDF file.
Log Search Function
- Displays a list of "Alarms," "Marks," "Image Marks," and "Operation History" logs recorded for each data files
- You can search logs using keywords and download log reports.
Report Function
- A report is generated based on the data recorded from multiple recorders
- The generation timing can be specified as scheduled (automatic) or immediate (manual)
- Generated reports can be printed automatically
- Report template：Daily Report/Monthly Report/Alarm Report/Periodic Report/Trend Report
※These functions are optional.
External Interface Function
- Provides trend data and periodic statistical data to other systems
Examples：Tag Information/Period Data/Alarm Information/Audit Trail etc.
※These functions are optional.
Configuration Tool
Adminstrator configures the Data Management Package using this tool.
- Register new recorders
- Register new users
- License management
Real-time Monitoring Software
Monitor measured data in real time
- Measured value display (Trend display / Digital display)
- Alarm notification on the screen
- Monitor data for each measurement group
Universal Viewer
Dedicated viewer software for browsing recorded data
- Display recorded data
- Supports latest OS and offers best viewing quality
- Supports 7 languages
Paperless Recorder
SMARTDAC+ Series
Measure and record a variety of data
- Add I/O modules as needed
- Wide variety of powerful display functions
- A full range of network functions
Advanced Security Function
Electronic recording of data is compliant with pharmaceutical regulations
- Logical security
- Audit trail function
- Secure data storage in binary format (fraud proof)
- Dedicated viewer software
Resources
Senju Pharmaceutical selected Yokogawa's Oprex EMS to ensure manufacturing quality.
EMS helps improve operational efficiency while complying with GMP and other guidelines.
Chugai uses the Pharmaceutical Model DX200P Data Acquisition Station for storage quality control of investigational drugs and ingredients.
Yokogawa Electric began offering the environmental monitoring system "OpreX Environmental Monitoring System" (hereinafter, OpreX EMS) for the pharmaceutical and medical device industries in October 2020. OpreX EMS, which was launched simultaneously domestically and overseas, is based on customers' needs, such as regulatory compliance, diversification of operational risks, and high usability. When asking the person in charge about the development history and features of the product, it was found that it is a new solution that meets the company's business vision.
Unlocking the Keys to a Sustainable Pharma Supply Chain
Videos
YOKOGAWA aspires to establish Smart GMP manufacturing facilities that provide consistent quality and supply while eliminating industrial waste, enhancing productivity and always using high-quality component parts and materials.
By equipping SMARTDAC+ with the advanced security features option "/AS", it meets the strict requirements of the U.S. FDA 21 CFR Part 11 and supports DI in compliance with PIC/S and ALCOA+ by WHO, MHRA and FDA.
By adopting the environmental monitoring system, we were able to create an environment in the cell storage facility that allows for quality control, maintaining a high level of safety.
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