The scope of the BG5 revision is machines and automated systems. All other computerized systems tumble underneath GAMP®. GAMP® describes a science risk-based tactic for components and application growth. For automation/System Command Programs connected to methods and products the user requirements specifications for every will have to align when
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nine.1 Previous to the commencement of any process validation studies it is necessary to show and certify the sort-fill-seal equipment and any supporting/subsidiary machines, sub-methods and services are correctly set up and working in accordance with their essential style and design parameters.6.one All information or information created because o
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