By Melanie Ziehm
A commitment to quality is essential to deliver safe, effective products that solve serious health issues and have a remarkable impact on people’s lives. This is demonstrated through development and implementation of a robust quality system designed to meet both customer and regulatory requirements. Product realization depends on the quality system to establish and maintain a state of control while facilitating continuous improvement.
A well-designed quality system has a global scope, incorporating guidelines from all relevant markets. This assures data quality and integrity through adherence to quality standards, policies and procedures. It also allows for the identification of benefits and risks which can be made available to those involved in making quality decisions. To expedite change, flexibility within the quality system is essential.