Introducing An Automated And Validated Calibration System
Case Study: Introducing An Automated And Validated Calibration System
AstraZeneca is one of the world's leading pharmaceutical companies with 30 manufacturing sites in 20 countries. The company has over 64,000 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 AstraZeneca 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. AstraZeneca made the internal, green-light decision for implementing a new calibration system in June 2004. In March 2005, the validation process began and by October 2005 the first calibrations were made. Recently, AstraZeneca Sweden Operations also made a contract 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 AstraZeneca Sweden Operations.
The situation
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 time-consuming.
"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.
Case Study: Introducing An Automated And Validated Calibration System