Validation

MCIC work with you to develop a customized URS until commissioning plan that outlines the responsibilities of design team, construction team, equipment suppliers, commissioning and Validation agent, and owner. MCIC provide the following validation and qualification services:

• URS
• Commissioning plan and protocols
• Site Master File; preparation and application
• Validation Plan or Master Plan (VP/VMP)
• Standard Operating Procedures (SOP)
• Quality Manual
• Risk Assessment
• Equipment Qualification and Validation Protocols (DQ, IQ, OQ, PQ, PV and CV)
• Facility and Cleanroom validation including design and supply the environmental indicators
• Air flow calculations
• Differential pressure measurement between the different adjacent area
• Particle Count Tests for non-viable particles
• HEPA filter DOP (dispersed oil particulate) tests
• HVAC System Qualification and validation tests
• Laminar Flow Systems Qualification and validation
• Safety Cabinet qualification
• Occupational Safety and Health measurements