QUALIFICATION

QUALIFICATION

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QUALIFICATION
QUALIFICATION

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Qualification activities •Instruments Calibration •Validation Master Plan and Qualification Plan Issue •Preparation and execution of: ⚬DQ, IOQ, PQ and Periodic Qualification ⚬Computer System Validation (CSV) ⚬Cleaning Validation •Data Integrity Assessment and Periodic Review •GxP, Regulatory and EHS Risk Analysis •SOP issuing and training For strategic projects we are able to provide the following resources: •C&Q Coordinator / Validation Manager •QA Specialist / Deviation and Change Control Manager •Technology Transfer Specialist •Supplier Auditor
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Pharmaceutical Machinery & Technology

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