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sales@dynamicautomation.com

validation-documentationDynamic Automation understands that successful machine design and program development goes hand-in-hand with comprehensive validation and documentation.

Every one of our machines includes a full build-to-print level documentation package.

Recognized good manufacturing standards (such as cGMP and GAMP 5) are integrated into the quality control processes throughout the design, build, and commissioning phases of our equipment.

Our validation experts use documentation templates to provide the thorough turn over package you need to ensure you can verify compliance with FDA requirements, ISO standards and other regulatory mandates.

Validation Documentation:

  • Design Documentation
  • Traceability Matrix
  • User Requirements Specifications (URS)
  • Hardware Design Specification (HDS)
  • Software Design Specification (SDS)
  • Mechanical Drawings, Electrical Schematic, Pneumatic Schematic, and Software Source Code
  • Operating Manual (w/ troubleshooting, spare parts, PM, etc.)
  • OEM Manuals
  • Data Reporting & Database Integration

Project Documentation

  • Project Gantt Charts
  • Project Action Items Lists

Testing & Qualification

  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)

SCADA Factory-Level Controls Systems

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