EasyLog | EL-21CFR-2-LCD+

129,99 ex. tax

21CFR High Accuracy Temp & RH Data Logger

EL-21CFR-2-LCD+
EL-21CFR-2-LCD+ 129,99 ex. tax

This high accuracy 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.

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).

Temperature:
Measurement range -35°C to 80°C (-31°F to 176°F)
Internal resolution 0.5°C (1°F)
Accuracy (overall error) 0.45°C (0.86°F) typical (5 to 60°C)
Long term stability <0.02°C (0.04°F) / year
Relative Humidity:
Measurement range 0 to 100%RH
Internal resolution 0.5%RH
Accuracy (overall error) 2.05%RH typical (10 to 90%RH)
Long term stability <0.25%RH/year
Logging rate User selectable between 10 seconds & 12 hours
Battery life 2 years (at 25°C and 1 minute logging rate, LCD on)

Could you explain what 21CFR Part 11 is?

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.

Would the 21CFR Cloud product be suitable for my company?

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 and medical industries. Also if you work within, and want to be compatible with, the US Pharmaceutical and medical industry and to streamline your record-taking accordingly, initiating a 21 CFR Cloud would be advantageous.

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