As a critical component of compliance, validation requires a thorough knowledge of all applicable regulations. NAYAport can provide your company with expert guidance for all forms of validation including: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). 
 

Our validation services include:

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Computer Systems Validation (CSV)

 

• Change Management Systems (CMS)

• Enterprise Resource Planning (ERP)

• Laboratory Information Management Systems (LIMS)

• Learning management systems

• Maintenance management systems

• Corrective Actions/Preventive Actions (CAPA) and Complaint Management Systems

• Manufacturing Execution Systems (MES)

• Training tracking systems

• Deviation/issue/event-tracking systems

• IT network infrastructure and security

• Document management systems

• Programmable Logic Controllers (PLC)

• Supervisory Control and Data Acquisition Systems (SCADA)

• Distributed Control Systems (DCS)

• Embedded firmware

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Cleaning Equipment Validation

 

• Weigh dispense systems

• Filling and mixing equipment

• Transfer systems

• Parts washers and autoclaves, CIP/SIP

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Manufacturing Equipment Validation

 

• Laboratory testing equipment

• API manufacturing

• Aseptic/sterile processing

• Water for injection systems

• Process chromatography equipment

• Robotics

• Injection-molding equipment

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Facilities and Utilities Validation

 

• Utilities including HVAC, compressed air and water systems

• Temperature and environmental mapping

• Equipment commissioning, validation and qualification 

• Customized IQ/OQ/PQ protocol development and execution