What is data integrity?
In every process, a lot of data is produced. Data integrity is the maintenance of, and the assurance of, the accuracy and consistency of the data over its entire lifecycle. It is a critical aspect to the design, implementation and usage of any system that stores, processes, or retrieves data.
The integrity of the data collected and recorded by for example pharmaceutical manufacturers is critical to ensuring that high-quality and safe products are produced.
Why are data integrity and regulatory compliance important?
Data integrity-related violations have led to several regulatory actions, such as warning letters and import alerts. A large number of warning letters issued by the FDA are related to data integrity.
As international regulatory agencies are focusing more and more on data integrity, FDA, WHOA and MHRA auditors have been trained to better recognize data integrity issues.
Data integrity in calibration processes
The impact of a breach of data integrity regulations can be significant. Hence, this should be a high priority, especially in pharmaceutical and other heavily regulated industries.
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Minimize the risk of errors
Beamex calibration solutions fulfill the requirements of FDA regulation 21CFR Part 11 and other relevant regulations for electronic records, electronic signatures and data integrity.
Beamex CMX Calibration Management Software includes Mobile Security Plus technology, which offers enhanced functionality with compatible offline mobile devices; the Beamex MC6 family of documenting calibrators and the Beamex bMobile Calibration Application.
Ensure calibration data integrity
Mobile Security Plus technology ensures calibration data integrity when executing calibrations offline, conforming with the commonly pharmaceutical regulatory framework of ALCOA. It does this by authenticating users and protecting calibration data from any unwanted changes.
Beamex CMX Calibration Management Software alone ensures data integrity but with Mobile Security Plus you can ensure that the data is not compromised even when working offline with supported mobile devices.
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Beamex has nearly 50 years of experience in developing and delivering calibration technology and expertise. Our experts around the world and our accredited calibration laboratories are here to support you.
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