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White Papers / Tech Papers

GMP Compliance that Spans the Supply Chain

Considerations for Extending the Quality System Beyond Your Enterprise

Released By ETQ

Executive Summary

Today’s rise in globalization means that the Life Sciences market is operating on a grander scale than ever before.

Life Sciences organizations typically extend manufacturing to suppliers or contract manufacturers, who directly affect the quality of the product. These suppliers are located around the world—globalization has eradicated distance and time zones and has unified regulated industries. However, for suppliers to effectively operate within this global environment, harmonization is needed.

Harmonization involves essentially enabling all sites within the global enterprise to “speak the same language” by creating a standard quality process that can be used by each site. The enterprise Quality Management System (QMS) takes this a step further by enabling different sites to operate on a common platform, while keeping their unique business processes. The QMS can support multiple sites on a single software environment,making it the ideal choice for maintaining harmonization initiatives.

This paper will explain how suppliers will benefit from being included in harmonization initiatives and will discuss the best practices of extending the quality system to the supplier. First, to fully appreciate the benefits that can be reaped by the supply chain, it is important to understand why the need for harmonization exists at all.

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