Validation Consulting
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Validation Plan / User Requirements / Risk Analysis (URS/RA)
Design and approval of Master Validation Plan • Design of User requirements specification • Risk analysis • Evaluation/validation of vendors.
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Form Sheets, Test Plans DQ – Design Qualification
Hardware and software design specifications • Software module design specifications • Network design specifications • Package units system requirements specifications • Design qualification of a.m. items.
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Application Specification / DQ Test plans / Qualification
Tests of hardware, construction and equipment • Tests of Software modules and coding • Software integration test • Test of network, configuration and components • Test of systems in Package Units (PU).
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Qualification of Installation (IQ)
Tests of: • Mechanical installation • Electrical installation • Equipment installation & calibration • Software installation • Network installation • Hardware installation acceptance • Network installation acceptance • PU installation acceptance.
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Operational & Performance Qualification OQ/PQ/ System acceptance test
Test of functions and operations • Stress test • Test of performance / reliability / repeatability / range • Experiments and optimization • Finalization of SOPs • System acceptance test • Validation Report • Maintenance of the validated state during life cycle time.