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.
What our customers say
Customer and regulatory audits have been heavily supported by Beamex functionality, always successful and heavily praised for its content we have had not a single issue with the data presented, viewed or reported on both internally and externally to FDA level.Paul Dixon, E&I Maintenance Manager, Sterling Pharma Solutions, UK
Ability to trend, ease of review and ease of use for my team of technicians. Auditors love this software so if you are using it right they have no doubt you are calibrating things right. Traceability, auditability great functionality when used with the Beamex calibrators & strong support of systems on site.Sterling Pharma Solutions, UK
The pharma industry is highly regulated, so it’s an exciting step to move to paperless calibration management in the cloud. Beamex CMX calibration software ensures we comply with all relevant GxP regulations and removes the risk of manual error, while working in the cloud with Azure gives us access to new technologies and enhanced performance that further improve the user experience.Don Brady, Tech Engineering Product Manager, GlaxoSmithKline Ltd, Ireland
Previously, the calibration was primarily done with manual and paper-based processes. The certificate was on paper, which was signed and stored in binders. After implementing the new calibration management process, the entire process takes place digitally, from measurement to signing and archiving.
The number of calibrations is continuously diminishing as calibration history-trend analysis allows us to identify instruments and sensors that remain stable over a long time, which means that the calibration interval for them can be extended without having an impact on production or quality.
Anders Rackow, Global Project Manager (GOI) AstraZeneca, Sweden
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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Your partner for calibration excellence
We help our customers evaluate and select the right technologies and services to fit their unique operations. We understand regulations and industry-specific best practices. We will help you continuously analyze, improve, manage and execute.
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.
Let our experts help you to find the best calibration solution for your needs.