Prior to Production Startup

Design and Validation

Our validation specialists have expertise based on education and extensive experience validating all types of computer systems and equipment. Our experts can work with your documentation standards or can provide proven document solutions to meet your needs and all FDA requirements. 

  • Functional Requirements
  • System Specifications
  • Structure Tests
  • System Simulation and/or Emulation
  • I/O Check-Out
  • Instrument Calibration

Valoit, Inc. will provide the client with the documented systems and infrastructure to meet all regulatory requirements for their facilities and processes. Our validation specialists have extensive experience in validating all types of systems and equipment. Our experience has shown that a well planned, logical approach to validation is key for success.

Valoit, Inc. can validate new systems, re-validate existing systems and provide ongoing validation training programs. Our validation services are completed in five phases: 1) Design Review/ Project Coordination; 2) Master Plan; 3) Protocol Development; 4) Field Execution; and 5) Reports and Certification. We also offer a variety of validation related services that can be supplied to accommodate existing programs and specific client/product requirements.

During Conception

  • Preliminary Validation Planning
  • Regulatory Consulting Service
  • Validation Training Program Development

During Design

  • Validation Master Planning
  • Protocol Development
  • Enhanced Turnover Package Development
  • SOP Development
  • Validation Training Program Implementation

During Construction

  • Enhanced Turnover Package Development
  • Enhanced Turnover Package Execution
  • Protocol Development
  • Initial Protocol Execution
  • SOP Development
  • Ongoing Validation Training Program

During Start-Up

  • Finish Protocol Development
  • Complete Enhanced Turnover Packages
  • Protocol Execution
  • Complete SOP Development
  • Final Report Writing
  • Ongoing Validation Training Program

Prior to Production Startup Equipment Validation Facilities Validation Computer System Validation

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