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