追加説明:
Qualification services cover instrument calibration; drafting of Validation Master Plans and Qualification Plans; execution of DQ, IOQ, PQ and periodic qualification; computer system validation; cleaning validation; data integrity assessments; GxP, regulatory and EHS risk analysis; and SOP development with associated training. For larger strategic projects, dedicated resources can be supplied, including a C&Q Coordinator/Validation Manager, QA Specialist/Deviation and Change Control Manager, Technology Transfer Specialist, and Supplier Auditor.
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