This WiFi-enabled temperature data logging sensor can remotely monitor an environment over a -40 to 125°C (-40 to 257°F) measurement range. Data is uploaded periodically using a standard WiFi network without the need to physically collect and connect the unit to a PC. Data is streamed wirelessly to the EasyLog 21CFR Cloud. The device will store data internally if it loses WiFi connection and automatically uploads it to the Cloud once reconnected.
Why buy a 21CFR logger?
The 21 CFR Part 11 regulations issued by the US Food and Drug Administration (FDA) give the criteria under which electronic records can be considered by the FDA as equivalent to paper records. If you need to meet these regulations or have enhanced data security requirements then you should choose one of our 21CFR loggers, otherwise our standard loggers will suffice. Learn more about 21 CFR Part 11.
21CFR Cloud subscription delivers all of the flexibility of remote monitoring and can be installed as part of a 21CFR-compliant system. Features include permission-based use, authority level sign-off and full system audit to ensure data monitored and collected is regulated to 21CFR Part 11 standard. This device requires a subscription to our EasyLog 21CFR Cloud service.
This product complies with BS EN 12830:2018 (Temperature recorders for the transport, storage, and distribution of temperature-sensitive goods).
Calibration testing carried out on our products provides assurance of the ongoing accuracy of your EasyLog data logger. This is relevant for all users, but is especially important for medical, food and scientific applications, and where audit compliance needs to be demonstrated. We provide a number of standard calibration options suitable for common applications such as monitoring fridges, chilled goods and freezers, but can also provide customized calibration at whatever measurement points you need. Please contact our sales team for details.
Calibration options available for the EL-WiFi-21CFR-TP:
The EL-WiFi-21CFR-TP temperature data logger is suitable for a wide variety of applications particularly those which require 21CFR compliant data collection and management as well as a wide temperature measurement range. These include:
For application stories on our data loggers, visit our case studies section.
Vaccine Storage
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21CFR Compliant Data Loggers
Offering 21CFR compliant data loggers ensuring secure, reliable data management and regulatory compliance.
Blood Storage
Implementing advanced data loggers for precise blood storage monitoring, ensuring safety and health standard compliance.
Food Temperature Monitoring
Data logging for comprehensive monitoring, crucial in upholding food safety and quality throughout the supply chain.
Veterinary and Animal Welfare
Incorporating state-of-the-art data loggers, to ensure optimal care, monitoring of health and environmental conditions.
The US FDA (Food & Drugs Administration) Code of Federal Regulations 21 Part 11, is an extension to the existing regulations that defines which electronic records and signatures that are to be considered accurate to replace paper records for the Pharmaceutical and Medical industry. Our system has been designed to assist companies comply with these regulations.
The product has been designed for companies which want to use electronic means to securely replace their paper records to comply with 21 CFR Part 11 regulations for the Pharmaceutical & Medical industries. Also if you work within, and want to be compatible with, the US Pharmaceutical & Medical industry and to streamline your record taking accordingly, initiating a 21 CFR Cloud would be advantageous.
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