GlaxoSmithKline is one of the world’s leading research based pharmaceutical and healthcare companies with a share of approximately 5% of the world’s pharmaceutical market. Headquartered in the UK, GSK is a global organization with offices in over 100 countries and major research centers in the UK, USA, Belgium and China. GSK employs 96,500 people and has approximately 13,000 people working on its research teams for discovering new medicines.
Implementing a powerful calibration management software
Beamex CMX Professional calibration management software was implemented at GSK in Cork, Ireland in November 2010, and it is used for all calibrations on site. GSK have deployed a powerful Beamex CMX calibration management system, which includes support for intrinsically safe Windows mobile PDAs and Beamex MC5-IS documenting calibrators to provide the FDA 21CFR part 11
compliant solution. The CMX calibration management software was fully integrated into the site’s Emerson AMS smart instrument asset management software ensuring that instrument range changes are reflected automatically in CMX and that any calibration results created in CMX are recorded in the AMS audit trail for the relevant asset. This project was implemented by GSK Cork Engineering and GMS Engineering Shared Service. New routines for standard work were also implemented for the new system.
The pharma industry is highly regulated, so it’s an exciting step to move to paperless calibration management in the cloud. CMX ensures we comply with all relevant GxP regulations and removes the risk of manual error. 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
21,000 sheets of printed paper eliminated
After implementing the Beamex CMX calibration management system, GSK were able to eliminate 21,000 sheets of printed paper on a yearly basis, as the entire flow of data occurs electronically, from measurement to signing and archiving. They were also able to eliminate all calculation errors and the need to recalibrate, because pass/fail records are now provided in real time. The process and system had reduced time and costs of the calibration itself and the
shut-down time in production. Another important factor was being able to obtain history reports and identify adverse trends in order to reduce the
calibration frequency without having an impact on production or quality.
Read the full GlaxoSmithKline Ltd customer case story
Thanks to CMX, an extension of the calibration interval, recommended e-mail alerts, was possible. With e-mail alerts upon calibration failure, only calibration failures now need to be reviewed and approved. In line with the interval extensions defined by the calibration blueprint, CMX has identified over 100 hours of savings in the first 3 months of operation. There was also an
8% reduction in scheduled calibrations implemented during data transfer from the history system. One third of lower criticality instruments (not related directly to quality, EHS or regulatory) were removed from scheduled calibration to calibration on demand, based on an instrument’s self-diagnostics, triggering calibration word orders. This has saved approximately 300 hours annually. During the project, GSK performed an audit of Beamex Quality and Product Development Systems with a positive outcome. Future development, including deployment of this solution to other sites, will be supported by a CMX Professional Software Service Agreement with continuous software updates and helpdesk if needed.