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Platform Independent Functional Specifications
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8. GAMP Life Cycle Does this includes Phase Logic, Loops, Basic Control? Rarely includes the detail Not a strong dependency Not a strong dependency
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12. Where does FRS fit in the Life Cycle Outline Function Requirements Detailed Functional Requirements Control Modules Phase Logic Procedures Graphics System Database
13. Requirements Analysis Identify Main Procedures Define Procedures Identify Operations Define Operations Identify Phases Define Phases Identify essential H&S Requirements Design appropriate Safety Systems Design Equipment Interlocks Implement Independent Safety Systems Piping & Instrument Diagrams Control & Operability Philosophy Process Description + Recipe Data Health & Safety Requirements Equipment Protection Requirements Identify Process Cells Define Process Cells Identify Units Define Units Identify Equipment Modules Define Equipt. Modules Identify Control Modules Identify Resources Define Resources Identify Control Modules Define Control Modules Order Here? Or Here?