FDA Validation Toolkit

Validate software quickly and efficiently

Software validation is required by the US Food and Drug Administration (FDA) and other key regulators to ensure that the pharmaceutical, biotech, and medical device firms' chosen enterprise software system – whether developed in-house or under contract – will be fit for purpose, and that it will consistently deliver the required outcomes.

The validation process is complex. It requires firms to follow specific controls and procedures, and then to provide detailed evidence that the system satisfies all requirements. Should an enterprise system be upgraded, then the validation process needs to start all over again. This is a time-consuming effort that many pharmaceutical, biotech, and medical device firms choose to manage manually.

However, the AX for Pharma 365 Validation Toolkit™ takes away the burden and makes the process simpler and easier. The solution enables timely validation by providing templates, documents, and procedures aligning with Good Automated Manufacturing Practice 5 (GAMP5) guidelines and recommendations.

Stage 1: Process Design

  • Define the Knowledge Space
  • Identify Critical Process Parameters
  • Determine Control Strategy

Stage 2: Process Qualification

  • Equipment / Utility / Facility Qualification
  • Process Performance Qualification

Stage 3: Process Monitoring

  • Monitoring of Critical Process Parameters as part of APR and Other Monitoring Programs
FDA Process Validation Guidance

The AX for Pharma 365 Validation Toolkit™ includes test scripts for the AX for Pharma 365™ modules as well as templates and samples for User Requirements Specifications (URS), risk analysis, Installation Qualification (IQ) protocol, Operational Qualification (OQ) protocol, Performance Qualification (PQ) protocol, design qualification, and the requirements-test scripts traceability matrix.

By taking advantage of these tools, biotech, pharmaceutical and medical device firms can not only ensure their compliance FDA regulations, but they can also boost efficiency, reduce validation costs, mitigate risks, and increase the chance of projects being completed on time and within budget.


  • Eliminate time-consuming processes.
  • Meet stringent regulations and guidelines.
  • Reduce validation costs.
  • Mitigate risks.


  • Specifically designed to comply with FDA Regulations and GxP Guidelines.
  • Aligned with GAMP 5 recommendations.
  • Support in Computer System Validation (CSV) and Computer Software Assurance (CSA).