21CFR Part 11 Compliant Data Loggers

Lascar's options allow users to collect and store data in compliance with the regulations of 21CFR Part 11 issued by the Food and Drug Administration (FDA). Even outside the USA where it originated, 21CFR part 11 compliance is fast becoming the de facto global standard for electronic records management and control in the food and pharmaceutical industries.

What is 21 CFR Part 11?

Regulations issued by the US Food and Drug Administration (FDA), their full name being Title 21 of the Code of Federal Regulations, Part 11. Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States; Part 11 provides the criteria for the FDA to accept submission of electronic records as equivalent to paper records.

Who Would be Interested in 21 CFR Part 11 Compliant Data Loggers?

Any company that needs to comply with the FDA regulation, for example biotech companies, pharmaceutical companies and medical device manufacturers. Compliance is required of US food, pharmaceceutical and healthcare companies and any such companies outside the US that want to operate in the US.  21CFR part 11 compliance is fast becoming the de facto global standard for electronic records management and control in the food and pharmaceutical industries.

How Are Lascar 21CFR Loggers Different from the Standard Loggers? What Additional Features Do They Offer?

Lascar 21CFR loggers use enhanced EasyLog 21CFR software that in addition to the core EasyLog capabilities offers the necessary functionality to comply with the regulatory requirement of 21 CFR Part 11, as detailed below:

  • User Control for Permission-Based Use - Ability to create users and assign individual users with specific permissions.
  • Full Audit Trails - Full software and session data audit trails showing user activity.
  • Electronic Signatures and Authority Sign-Off - Electronic signatures for all activity. This means the addition of electronic signatures to all reports to show who has started, stopped and approved the session data, and allows for authority sign-off.
  • Encrypted Data Storage - Encrypted data which cannot be edited. 
  • Failed Log In Alerts - E-mail alerts for failed log in attempts.
  • Comment Approval - Comments on specific readings must be approved by an authorised user for final submission. 

How to Use Lascar 21CFR Loggers

For guidance on how to use these products, see our 21CFR playlist on YouTube.

If I Buy a Lascar 21CFR Logger Does that Mean I Am 21CFR Part 11 Compliant?

It has the required functionality needed to achieve compliance. However, you can only become compliant by implementing all the required procedures to FDA standards within your company. Using a Lascar 21CFR logger is not enough alone to achieve compliance, it must be used in the correct way, and the onus for that is on company procedures.   

How Can I See that Lascar 21CFR Loggers Meet the Detailed Requirements of 21 CFR Part 11 Regulation?

See our 21CFR Part 11 Requirements Checklist which can be used as the basis for your IQ/OQ/PQ validation.

Examples of the Lascar 21CFR Range

Lascar 21 CFR Part 11 Compliant Loggers can be identified because they contain 21CFR within the product number. 

Remote WiFi Data Loggers
For users seeking a remote monitoring option, Lascar’s EL-WiFi-21CFR Series provides eleven WiFi-based sensors wirelessly capturing and storing data for access from any internet-enabled device. Examples of the range are the EL-WiFi-21CFR-TH temperature and humidity data logger and the the EL-WiFi-21CFR-VAC vaccine temperature monitor. 

Standalone USB Data Loggers
Lascar's 21CFR range offers seven standalone USB devices.  Examples are the EL-21CFR-1-LCD temperature data logger, and the EL-21CFR-TP-LCD for monitoring temperature using an external thermistor probe.

Further Reading on 21CFR Part 11

FDA Guidance for Industry on 21 CFR Part 11

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