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Project: planning  design   management Organization: assessment  planning  design Technology: assessment  protection transfer Facility: planning design construction qualification validation  documentation audits/inspection Systems: assessment design validation documentation audits/inspection Production: training documentation audits/inspection Q.C./Q.A: training documentation audits/inspection Clinical Trials: planning design management documentation data review and analysis Registrations: establishment product in U.S. outside U.S. Added information:  When services may be required: immediately within 3 months within 6 months this year

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