What is calibration data integrity

What is data integrity and why worry about it?

Data integrity is the maintenance of, and the assurance of the accuracy and consistency of the data over its entire life-cycle. It is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.

IMPACTS DECISION MAKING

COMPLIANCE TO REGULATIONS

AUDIT REQUIREMENTS

Customer Experiences

With this software integration project, we were able to realize a significant return on investment during the first unit overhaul. It’s unusual, since ROI on software projects is usually nonexistent at first. The most significant impact overall is that Salt River Project has been able to save about 30 minutes per calibration using an automated approach. This equates to 2,300 hours saved since their go-live date.
Jody Damron, Salt River Project (Power Generation)
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Calibration Process Change in 6 Steps

Regulatory Compliance

Data integrity related violations can led to several regulatory actions. A large number of the recent warning letters issued by FDA are somehow related to data integrity. As international regulatory agencies have more focus on data integrity, the FDA, WHOA and MHRA auditors have been trained to better recognize data integrity issues.

Beamex MC6 calibrator, FB temperature block and CMX calibration software

Minimize the risk of errors

The Beamex calibration solution fulfills the requirements of 21 CFR Part 11 and other relevant regulations for electronic records, electronic signatures and data integrity. CMX version 2.11 introduced Mobile Security Plus, which offers enhanced functionality with compatible offline mobile devices, such as Beamex MC6 family of documenting calibrators and tablets/smartphones with the Beamex bMobile 2 application. This enhancement further lowers the risk of ALCOA violations by identifying those using offline mobile devices by their electronic signature and by protecting the offline data against tampering.

Find out more about Beamex CMX calibration software

Data Integrity