GAMP 5 - Good Automated Manufacturing Practice
Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 4.1: 4.1 Concept Phase

In the concept phase the regulated company identifies and evaluates the business need or opportunity, considers potential solutions and the associated benefits, costs and risks, and decides whether to proceed to a project. The use intended for the system is set within the business process it serves, initial requirements and the regulatory context are considered, and the outcome is a decision and a justification that lets the project phase begin with a clear scope; for systems using machine learning, data management and data dependencies must be understood at this early stage, since data is the central resource.

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