EasyLog | EL-21CFR-1-LCD

89,49 ex. tax

21CFR Temperature Data Logger with Display

EL-21CFR-1-LCD
EL-21CFR-1-LCD 89,49 ex. tax

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) range. At the touch of a button, use the on-board display to cycle between the current, minimum and maximum temperature logs seen during the session.

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).

Measurement Range -35 to +80°C (-31 to + 176°F)
Accuracy (overall error) +/- 0.5°C typical
Readings 16,379
Logging Rate User selectable between 10 seconds and 12 hours
Battery Life 2 Years

 

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.

Why aren’t my batteries working?

If left unused for extended periods of time lithium metal batteries, including those used in the EasyLog range of data loggers, naturally form a non-conductive internal layer – a Passivation layer – preventing them from self-discharge and effectively increasing their shelf life. When first installed in the data logger, this may cause a momentary drop in the battery voltage (the Transient Minimum Voltage) as the internal layer is broken down, resulting in the data logger resetting. Inserting the batteries in the data logger and leaving it connected to a PC for about 30 seconds will remove this layer. After this, remove and re-install the batteries to reset the data logger. Overall battery life will not be affected.

More support