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The GAMP method is a project management method for doing projects within the pharma / F & B / BIO and other markets where validation is required for external regulators. The GAMP method states that a project starts with a numbered number of requirements, and that these numbers can be traced back to all project documentation. In this way, it can be seen from document to document which technical measures and solutions which users’ requirements bring about.

GAMP proposes to go through 4 main phases. The documents that are delivered are the following:

  • User Requirement Specification (URS)
  • Function Design Specification (FDS)
  • Hardware Design Specification (HDS) / Software Design Specification (SDS)
  • Module test documentation
  • Factory Acceptance Test (FAT) validation
  • Installation Qualification (IQ) Validation
  • Operational Qualification (OQ) Validation

These documents record that a system has been designed, manufactured and tested according to the requirements of the customer, and that the customer has purchased the operation of the system according to the requirements. This means that the customer approves the system based on the requirements set at the start of the project.

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