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AstraZeneca is one of the world’s leading pharmaceutical companies with 30 manufacturing sites in 20 countries. The company has over64,000 employees worldwide and sales in 2004 totalled $21.4 billion. Their products are available in more than 100 countries. Beamex made a corporate agreement with Astra Zeneca Sweden Operations, which means that eventually every production site in Sweden will be using CMX for calibration management. The contract includes Beamex’s CMX calibration management software licenses, training and software support. Astra Zeneca made the internal, green-light decision for implementing a new calibration system in June 2004. In March 2005,the validation process began and by October2005 the first calibrations were made. Recently, Astra Zeneca Sweden Operations also made acontract with Beamex regarding the procurement of equipment and calibration service.
Anders Ånlind is a Calibration Manager at AstraZeneca Sweden Operations and his responsibility was to manage, co-ordinate and implement the new calibration management system at
Sweden Operations.
The starting situation at AstraZeneca Sweden Operations was challenging and the company had many demanding requirements for a calibration system. First of all, a calibration system should save money for the company by reducing the time it takes to perform calibration and the time production lines are shut down due to calibration. Secondly, the amount of calibrations was huge. Approximately 21,000 calibration certificates are made in total on a yearly basis. This is both expensive and timeconsuming. “We needed to reduce the time from start to finish”, Anders Ånlind begins. There were also other requirements for the new calibration system. “We needed a tool that would highlight adverse trends in calibration,” Anders continues. Items should be identified before they are out of tolerance. Likewise, if the item delivers good performance, it is justified to reduce the calibration frequency. Finally, the system should provide quick and easy access to data. Data should be available through any desktop computer within AstraZeneca. Going through huge certificate archives is difficult. Furthermore, AstraZeneca Sweden Operations wanted to get rid of all typing errors related to handwritten calibration certificates.
These were the factors behind AstraZeneca Sweden Operations decision to choose Beamex’s CMX for their calibration management software. “According to suppliers of maintenance systems, we introduced the most effective, automated and validated calibration process known in the pharmaceutical industry”, Anders states.
At the moment, AstraZeneca Sweden Operations is utilizing Beamex’s CMX calibration management software (CMX for server) with the Pocket PC option, as well Beamex’s documenting MC5 Multifunction Calibrators. Using the CMX with the Pocket PC option allows AstraZeneca Sweden Operations to extensively utilize PDAs (Personal Digital Assistant) for manual data entry on site. The server version of CMX makes it possible for several plants within the corporationto use and share the same database.
The implementation of CMX introduced many new benefits in the workflow of performing and managing calibrations and it also solved the problems that were related to the former calibration system. They had multiple calibration processes within Sweden Operations due to 12 different databases and 4 to 5 different workflows. AstraZeneca Sweden Operations now has a new uniform calibration process. In addition, the new calibration process has proved to be very cost effective. It has replaced manual verifications and approval of results after performed calibration with an automated and validated process. The History Trend function also allows AstraZeneca to use the CMX as a tool for identifying adverse trends and good performance. Paper documentation is being replaced with ElectronicRecord data, which is stored in the CMX database. However, the system also provides the possibility to print calibration certificates, in case they are needed.
Even though the new CMX system has proven to be much more efficient and cost-effective, it is still compliant to regulatory requirements. This was an essential requirement when AstraZeneca began looking for a new calibration system. With CMX, AstraZeneca Sweden Operations has a validated calibration system with full Audit Trail, which is compliant with 21 CFR Part 11.
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