Implementing An Integrated Quality System To Support Business Growth

A multinational pharmaceutical company with world-wide commercial operations provides contract manufacturing, product development and clinical services to third-party customers. Geographically-dispersed and disconnected business units demanded virtual collaborations that were not easy to support, and many processes throughout the company were manual and disconnected, hindering productivity and collaboration. The company implemented a solution to enable them to deliver high quality, compliant products in an efficient manner.

A multinational pharmaceutical company with world-wide commercial operations develops, manufactures and distributes generic, biosimilar, brand and over-the-counter products. The company provides contract manufacturing, product development and clinical services to third-party customers. It is important for the organization to successfully meet compliance requirements for regulatory agencies worldwide, including FDA, EMA and ANVISA which requires them to set high standards throughout their organization.

A rapid expansion through acquisitions of different organizations with diverse lines of business led to significant organizational challenges. Geographically-dispersed and disconnected business units demanded virtual collaborations that were not easy to support. Productivity and collaboration was further hindered by the manual and disconnected processes throughout the company.

In order to continue to deliver high quality, compliant products in an efficient manner the company decided to replace their legacy electronic Common Technical Document (eCTD) system (used in all regions) and to implement a global Quality Management System.