cGxP

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Software Validation Services
 
cGxP has great technical expertise and regulatory insight in prospective and retrospective software validation. Our validation specialists have expertise validating all types of computer systems and equipment. We can assist in software design control, development and implementation from specification development, coding, validation/verification and bug control.  We excel in:   
 
  • Software used in manufacture 
  • Quality Documentation Systems
  • LIMS
  • Programmable Logic Controller (PLC)
  • Chromatography Data Systems
  • Distributed Control Systems (DCS)
  • Facility Monitoring Systems (FMS)
  • Computer System Validation (PEMS/LIMS/COTS/PLC)
  • Electronic Signatures: Part 11
  • Standard Operating Procedures
  • Installation Qualifications
  • Operational Qualifications
  • Performance Qualifications
  • Validation Master Plan & Audits
  • Lifecycle Approach
  • Certification Procedures
  • Automation and Control Systems
  • P & ID Development
  • System Network Design
  • Development of Control Requirements
  • Level 1, 2, and 3 Integration Master Plans
  • Design Engineering
  • Development of System Specifications
  • Modular Coding/ Testing Techniques
  • Code Simulation and Emulation
  • Control System Design
  • Commissioning
  • Functional Requirements
  • System Specifications
  • Structure Tests
  • System Simulation and/or Emulation
  • I/O Check-Out

     

 

 

 

 

 

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