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Tracking parameters for the pharmaceutical sector
Pharmaceutical temperature monitoring systems
- 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!