Lascar 21 CFR Part 11 DataLogger, USB Thermocouple

Lascar 21 CFR Part 11 DataLogger, USB Thermocouple

Lascar 21 CFR Part 11 Compliant USB Thermocouple Data Logger

This standalone 21 CFR Part 11 compliant temperature data logger is high accuracy and can record over 16,000 readings across a temperature range of -35 to +80°C (-31 to +176°F) and 0 to 100% relative humidity (RH). With on-board LCD display you can view current, minimum and maximum logged values for temperature and humidity at the press of a button. The LCD display is highly responsive even at low temperatures. You can cycle through these readings during a session for easy monitoring. The logger also has an alarm function to alert you to out of range conditions.

Why a 21 CFR logger?

The FDA’s 21 CFR Part 11 regulations define the criteria for electronic records to be equivalent to paper records. If you need to comply with these regulations or require extra data security our 21 CFR loggers are the way to go. Otherwise our standard loggers may be sufficient. Learn more about 21 CFR Part 11. By switching from paper record keeping to electronic recording you get improved reliability, repeatability and compliance to regulatory standards.

When used with Lascar’s 21 CFR Part 11 software the logger has all the features of the original EasyLog software plus added 21 CFR functionality like user permissions, encrypted and tamper-proof data, full audit trail and electronic signatures for all activities. The logger has audit trail functionality to ensure transparent and unaltered records of all actions. The compliance software is available to download after registration and is compatible with other regulated environment solutions. These core offerings – compliance, security and data management – make the logger a top choice for regulated industries.

Setup is easy – just plug the logger into a PC’s USB port to configure the device and view data using the included 21 CFR Part 11 software. The system is validated to meet FDA requirements and you need to demonstrate the system meets the requirements during validation. The logger comes with ½ AA battery and wall mount clip. Management of electronic records, access controls and system procedures is key to compliance.This product also meets BS EN 12830:2018 for temperature recorders used in the transport, storage and distribution of temperature sensitive goods. The company is responsible for 21 CFR Part 11 compliance.

Security and User Management:

The logger has electronic signatures, access restrictions and document verification to ensure data integrity. Access controls ensure only authorized users can access critical data and system functions. User roles and permissions are key to system security and compliance. You need to evaluate system accessibility and security controls to ensure data integrity.

Note: Please document checks and system evaluations.

Electronic Records and Data Management:

The logger allows creation and modification of electronic records as part of the process. Reliable recording, reporting tools and ability to generate reports are included. The logger’s reliability and repeatability ensures consistent performance and data. Each entry records the date and time to ensure authenticity. You must complete and verify all steps before exporting or validating records.

Temperature:

Measurement range                      -35°C to 80°C (-31°F to 176°F). For accurate temperature readings within this range, consider using a Type T thermocouple.

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)

Calibration Certificate                  Available Separately

Temperature Data Loggers

Temperature data loggers are electronic devices that monitor and record temperature and humidity over time, a solution for industries where environmental control is critical. In pharmaceutical, food and healthcare sectors, precise temperature and humidity control is essential for product safety, quality and regulatories. These data loggers automatically capture and store data, creating electronic records that can be easily viewed. With the increasing adoption of 21 CFR Part 11 which governs electronic records and electronic signatures in FDA regulated industries, temperature data loggers are a must have for monitoring processes to meet federal regulations. By replacing paper records with digital systems companies, improve data and be able to monitor and storage and transportation conditions across many applications.

Features

The EasyLog EL-21CFR-1-LCD temperature data logger has all you need for a regulated environment. With a wide measurement range and high accuracy this data logger can capture detailed temperature profiles for critical applications. The integrated LCD display allows you to cycle through current, minimum and maximum readings during a session for easy monitoring. Data is at the core of full audit trail, digital signatures and user permissions to ensure all electronic records are protected and traceable. The logger is compatible with dedicated PC software for 21 CFR Part 11 to make the workflow of configuring the device, managing data and having a secure and tamper evident record of all activities seamless. This makes the EasyLog EL-21CFR-1-LCD the perfect choice for users who need reliable, secure and compliant temperature monitoring.

Compliance

Meeting regulatory requirements is key for companies in FDA regulated industries and the EasyLog EL-21CFR-1-LCD temperature data logger is designed to meet 21 CFR Part 11. This means all electronic signatures, audit trails and permissions are managed according to federal regulations so you have a secure and reliable way to record and monitor temperature data. The logger also meets other key standards such as BS EN 12830:2018 for temperature recorders used in the transport, storage and distribution of temperature sensitive goods. By using a 21 CFR Part 11 compliant data logger you can monitor your processes, reduce the risk and demonstrate best practice across the supply chain. This safeguards product quality and safety and simplifies regulatory reporting and audit readiness.

Software and Functionality

The software that comes with the EasyLog EL-21CFR-1-LCD temperature data logger is designed to be functional and easy to use. You can configure the logger, download data and generate reports all within a 21 CFR Part 11 compliant environment. The software also has advanced data analysis and graphing tools so you can trend, monitor and make decisions based on temperature data. The interface is intuitive so users of all experience levels can manage and view data efficiently and compatibility with other devices and systems means you can integrate into your existing workflow. The software enhances the capabilities of the data logger and supports data management and regulatory compliance for many applications.