This 21 CFR Part 11 compliant standalone data logger measures more than 16,000 readings over a -35 to +80°C (-31 to +176°F) and 0 to 100% relative humidity (RH) range. At the touch of a button, use the on-board display to cycle between the current, minimum and maximum logs seen during the session for both temperature and humidity.
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.
Used in conjunction with Lascar’s 21CFR Part 11 software, the logger enjoys all of the core offerings of the original EasyLog software, but with additional 21CFR characteristics including user permissions, encrypted data which cannot be edited, full audit trail and electronic signatures for all activity.
Easily set up the logger and view downloaded data by plugging the unit into a PC’s USB port and using the free 21CFR Part 11 software provided. Supplied with ½ AA battery and wall mount clip.
This product complies with BS EN 12830:2018 (Temperature recorders for the transport, storage, and distribution of temperature-sensitive goods).
PLEASE NOTE: You can add up to TWO SPARE BATTERIES for every data logger ordered. If you wish to order more than this quantity, please contact your local sales office for special shipping information.
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-21CFR-2-LCD:
The EL-21CFR-2-LCD temperature and humidity data logger has been specifically developed to meet the data security required by the FDA’s 21CFR part 11 regulations. As such it is suitable for use in applications where the integrity of the data is of the highest importance.
For application stories on our data loggers, visit our case studies section.
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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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