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GAMP/FDA | HELIX Gesellschaft für Software und Engineering mbH


We support and look after our customers from the pharmaceutical industry in all three cycles of process validation according to FDA:

  • Process design during development or engineering
  • Process qualification from engineering to operation of the plant systems
  • Continued process verification during manufacture

We offer the following scope of services:

  • Creation of user requirements
  • Change Control
  • Design Qualification (DQ)
  • Factory acceptance test at the supplier (FAT)
  • Site acceptance test (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Validation (prospective, retrospective)
  • Qualification
  • 21CFR11
  • Recipe creation
  • SFC
  • CFC
  • Visualizations
  • Integration of package units via all common interfaces
  • Documentation (user requirements, specifications, design, operating instructions)