Contact Us

North America

AX for Pharma North America LLC.
100 S. Ashley Drive, Suite 600
Tampa, FL 33602
United States

Europe

AX for Pharma Europe
Centro Direzionale Milano Due
Palazzo Bernini, 701-704
20090 Segrate (Milan)
Italy

FDA Validation Toolkit

FDA Validation Toolkit

AX for Pharma’s Validation Toolkit facilitates the certification process by providing templates, documents, and procedures that align with GAMP 5.

Included in the FDA Validation Toolkit

  • Test scripts for the AX for Pharma modules

  • Templates for the following:

    • User Requirements Specifications
    • Risk Analysis
    • IQ protocol
    • OQ protocol
    • PQ protocol
    • Design Qualification
    • Traceability Matrix
  • Examples of the following:

    • Validation Plan document
    • Validation Project Plan
    • User Requirements Specifications
    • IQ protocol for AX and AX for Pharma
    • OQ protocol for AX for Pharma
    • Change Control procedure and Change Register

Contact Us

North America

AX for Pharma North America LLC.
100 S. Ashley Drive, Suite 600
Tampa, FL 33602
United States

Europe

AX for Pharma Europe
Centro Direzionale Milano Due
Palazzo Bernini, 701-704
20090 Segrate (Milan)
Italy