In regulated environments, GMP principles and regulations require companies to evaluate their suppliers and their quality data. An effective quality management system (QMS) is the foundation for supplier management, in addition to controlling the quality of products and processes. The use of supplier quality software is a good way to connect an organization's QMS to its suppliers' QMS, or at least, to allow suppliers access to the organization's QMS for the purpose of participating in quality and compliance processes.
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Supplier quality software in today's market is based on existing regulatory requirements that affect suppliers. In the U.S., the Food and Drug Administration (FDA) requires supplier audit for pharmaceutical, biotech, medical device, and other life science companies. It also requires medical device companies to maintain quality agreements with their suppliers.
In Europe, various directives and guidances call for supplier quality agreements. Life science companies that do business in Europe have to establish supplier quality systems that conform to those directives and guidances.
Whether in the United States or elsewhere, life science and other regulated companies are generally expected to maintain quality agreements that provide certain essential elements, which should also be reflected in their supplier quality systems:
Companies that use contract research organizations (CROs) and suppliers are responsible for monitoring the quality of the materials and services provided to them. The sponsoring company and its suppliers should agree on the means of monitoring, such as the use of key performance indicators (KPI) and performance audits. In both cases, the use of supplier quality software as platform for supplier quality management can be very helpful for sponsors and suppliers.
MasterControl's supplier quality software solution automates and streamlines the process for managing suppliers and for ensuring the quality of the materials and services they provide. MasterControl uses a web-based platform for supplier quality management so you can be connected with all of your critical suppliers regardless of where they are located.
Here are some of the benefits and features offered by MasterControl's supplier quality software solution:
To learn more about MasterControl's supplier quality software systems, contact a MasterControl representative.