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Tracking parameters for the pharmaceutical sector
Pharmaceutical temperature monitoring systems
Monitoring storage and production facilities
Collecting critical data up to the last mile
Applications and software for monitoring
Real-time alarms and alerts
OCEASOFT's wireless and connected solutions for the pharmaceutical industry:
- meet the standards defined in the guidelines for Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP),
- comply with 21 CFR PART11 requirements, FD X 15-140, IQ-OQ, Validation, and more.
- allow continuous, 24/7 monitoring of the critical physical parameters affecting your sensitive products,
- provide a complete audit trail and traceability,
- are integrated with advanced with real-time alert management systems,
- include data access, control and management via web and mobile applications.
Regulatory requirements and guidelines in the pharmaceutical industry, notably GMP Pharma, GDP*, 21 CFR part 11, GDP Pharma*, and others, continue to grow stricter. Professionals in this sector are obliged to implement high-performance monitoring and traceability solutions for pharmaceutical cold-chain logistics, while complying with ICH guidelines for pharmaceuticals and FDA pharmaceutical guidelines.
Molecules studied during the pre-clinical phase, or tested during clinical trials, such as pharmaceutical products (medicines, vaccines, etc.) in production then storage phase, must be monitored in real time as part of the pharmaceutical cold-chain monitoring process (in refrigerators and -80°C freezers, etc.). This must be done in order to prevent any temperature excursions or other anomalies in terms of CO2 level, relative humidity or differential pressure.
* GMP Pharma: Good Manufacturing Practices for the pharmaceutical sector
* GDP Pharma: Good Distribution Practices for the pharmaceutical sector
Scroll down to discover OCEASOFT monitoring solutions for the pharmaceutical industry!
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Monitoring storage and production facilities
OCEASOFT temperature data loggers for fixed facilities, such as temperature control for cold rooms, freezers, and other equipment used in pharmaceutical temperature monitoring, constantly monitor a number of physical parameters, including temperature, humidity, light exposure, differential pressure, CO2 level, etc.
All these parameters are continuously recorded to ensure the timely management of alarms and alerts in the event of an anomaly. OCEASOFT provides you a reliable solution that complies with the strictest standards and regulations in your field.
Collecting critical data up to the last mile
OCEASOFT's mobile monitoring solutions offer a reliable and easy way to monitor the temperature of your products and thermosensitive molecules during transport, 24/7. Emerald and Atlas, OCEASOFT's standalone Bluetooth temperature data loggers, use universal Bluetooth Low Energy connectivity. Remotely accessible, they can read data even through packaging.
No need to take them out of the box or container to check readings at intermediate points or at your destination. In addition to saving precious time, this innovation significantly reduces the risk of temperature excursions to further optimize pharmaceutical cold chain logistics.
Applications and software for monitoring
Paired with our software and our web, mobile and PC apps, OCEASOFT connected sensors give you easy access to your data at any time. Your audit reports are automatically generated and can be exported in various formats. You also benefit from unlimited data storage on your server or on the OCEASOFT OCEACloud. All our apps are designed to comply with the strictest regulations, such as the FDA 21 CFR PART 11. Our in-house Metrology lab is ISO/CEI 17025 COFRAC-certified to calibrate sensors, and guarantees the highest reliability of sensors and readings.
Real-time alarms and alerts
All our solutions are paired with our alerts and alarms management tool. These alerts notify you in real time of any excursion or technical anomaly and allow for robust monitoring of sensitive products. You can choose how you wish to receive alerts (by fax, e-mail, SMS, audio or visual alarms, etc.), which will simplify and accelerate your decision-making process to take corrective action.
