pH meter EzpH with Ezintegrity: The 21 CFR Part 11 compliant solution

For pharmaceutical laboratories and other highly regulated industries, measurement requires not only accuracy but also complete data integrity and traceability. The EzpH Meter with Ezintegrity software by Electrolab is engineered to meet these exact demands, offering a modern, precise, and fully 21 CFR Part 11 compliant measurement solution.

Superior features of the EzpH meter with Ezintegrity

This product combines top-tier measurement performance with comprehensive data security features.

Comprehensive 21 CFR Part 11 compliance

This is the core and most distinguishing feature of this model. With the Ezintegrity software, the device provides a full suite of compliance features, including multi-level user management, an unalterable audit trail, and electronic signatures. This ensures all generated data is secure, tamper-proof, and legally valid, a mandatory requirement for submissions to the FDA and other regulatory bodies.

Modern touch interface and intuitive operation

The large 7-inch color TFT touch screen makes operation incredibly simple. The user-friendly graphical interface and built-in instructions allow users to easily perform calibrations, measurements, and data management without complex training.

Comprehensive data management and connectivity

With a large memory for 1000 reports, direct connectivity to printers via USB, network, or Wi-Fi, and data export to a USB drive, the EzpH with Ezintegrity offers maximum flexibility in managing and archiving records in accordance with GLP principles.

Professional calibration for high accuracy

The meter supports up to 5-point pH calibration, ensuring high accuracy (±0.01 pH) across the entire measurement range. The Automatic Temperature Compensation (ATC) feature eliminates interferences from temperature variations, providing the most reliable results.

Detailed technical specifications

• Model: EzpH with Ezintegrity

• Compliance: 21 CFR Part 11

• Parameters: pH, ORP, mV, Temperature

• pH Range: 0 to 14.000 pH

• pH Resolution: 0.001 pH

• pH Accuracy: ±0.01 pH

• pH Calibration: Up to 5 Points

• Display: 7-inch TFT touch screen

• Storage: 1000 reports

• Connectivity: USB (printer, drive), Wi-Fi, Network

Frequently asked questions (FAQ)

1. What does the “Audit Trail” in 21 CFR Part 11 mean?
An Audit Trail is a secure, computer-generated, time-stamped electronic record that independently records all actions related to the creation, modification, or deletion of an electronic record. This trail cannot be altered, which helps ensure data integrity.

2. How is this model different from the standard EzpH meter?
The biggest difference is the software. This model is integrated with Ezintegrity software, making it fully compliant with 21 CFR Part 11 regulations. The standard EzpH model is GLP compliant but lacks the advanced data security features like audit trails or electronic signatures.

3. Do I need a computer to print my results?
No. One of the key advantages of this meter is its ability to connect directly to a printer via a USB port or over the network (Wi-Fi/Network), allowing you to print GLP/21 CFR Part 11 compliant reports on the spot.

4. What can this meter measure besides pH?
In addition to pH, the meter can also measure Oxidation-Reduction Potential (ORP) when using an ORP electrode, relative mV, and the temperature of the solution with a temperature probe.

5. Can I set up passwords for different users?
Yes. A crucial part of 21 CFR Part 11 compliance is access control. You can create different user accounts with various permission levels (e.g., administrator, operator) to control who can perform which actions on the device.