GAMP 5 - Good Automated Manufacturing Practice
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 6.1.4: 6.1.4 Managing Supplier Relationships

Suppliers and service providers of computerized systems and services are assessed for their quality capability, the reliance placed on them is decided on that basis, their responsibilities and the regulated company's expectations are defined in contracts, quality agreements or service level agreements, and their performance and continued suitability are monitored and periodically re-evaluated. The regulated company leverages supplier knowledge, documentation and testing where the assessment supports it, retains accountability for compliance, and manages the relationship so that changes, incidents, support, data location and exit are handled in a controlled way.

Maintained by Gerard BlokdykControl text last updated

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  • Clause 3 Suppliers and service providers

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Other controls in Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

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