February 2015

Case Study: QMS Re-Design Case Study

A highly diversified pharma company based outside Europe has grown by acquisition and as a consequence has developed a range of quality management systems (QMSs) and inherited a number of others. It consisted of a number of sites managed directly by the organization, and nearly 50 subsidiaries that were managing the sale of major products. These subsidiaries often used local contractors to manufacture other products for the local market only. Furthermore, the company strategy was to increasingly outsource more of its activities, with only a very few sites managed directly by the company. At the time of this project, there were nearly 300 external organizations across the company, directly involved in the development, manufacture, testing and distribution of the company’s products. So much diverse activity proved a
challenge for the global quality function.