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Calibration solution technology ensures data integrity in the pharma industry

04 May 2018

Today’s pharmaceutical industry is forced to alter its approach to calibration data integrity due to significant changes to regulation. New regulations, like those released by MHRA and FDA, will be the main focus of auditors and will have a profound effect upon companies maintaining compliance.

“A clearer regulation is a very important step towards improved data integrity and patient safety. That is why Beamex decided to gather some of the largest and most influential pharmaceutical companies in the world to give guidance in developing a new solution meeting the global needs of the industry. This solution is truly unique,” proudly explains Beamex CEO, Jan-Henrik Svensson.

Beamex has over 40 years of experience in process instrument calibration. Through the combination of calibrators and calibration software, Beamex customers experience major benefits from a paperless and automated calibration process, while significantly reducing the opportunity for human errors. With the release of Beamex Mobile Security Plus, the automated calibration process can now be completed offline using mobile devices while continuing to fulfill data integrity requirements. This new feature for mobile devices now includes user authorization and prevents any calibration data from time tampering, manual errors, false signatures, illegibility, inaccuracy and much more.

Beamex continues to lead the calibration industry with the launch of this new revolutionary solution that provides pharmaceutical companies the tools to achieve greater levels of calibration data integrity, ultimately improving patient safety. 

“Our CMX Calibration Software has always fulfilled the requirements of 21 CFR Part 11 and other relevant regulations. Together CMX and the latest enhancements to our portable off-line mobile devices, essential to meet the needs of our customers, deliver today’s necessary levels of data integrity,” describes Beamex Product Manager Antti Mäkynen. “These mobile off-line devices include our portable documenting multifunction calibrators MC6 and MC6-Ex as well as our bMobile application for tablets and mobile phones,” Mäkynen adds. 

Many Beamex customers have selected Beamex calibration software, portable calibrators, and comprehensive launch and support services for their enterprise-wide solution. Calibration data has been connected and shared with their globally deployed ERP, maintenance system or instrument and asset management system to achieve end-to-end paperless calibration, streamlined processes, and truly mobile working while ensuring integrity of the data and regulatory compliance.

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