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Validation

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:

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

Cleaning Equipment Validation

 

  • Weigh dispense systems

  • Filling and mixing equipment

  • Transfer systems

  • Parts washers and autoclaves, CIP/SIP

Manufacturing Equipment Validation

 

  • Laboratory testing equipment

  • API manufacturing

  • Aseptic/sterile processing

  • Water for injection systems

  • Process chromatography equipment

  • Robotics

  • Injection-molding equipment

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

Need more details? Contact us

We are here to assist. Contact us by phone, email or via our Social Media channels.

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