AXP365 Validation Toolkit™

Validate Software Quickly and Efficiently

If you’re in a sector such as biotech or life sciences, then you’re familiar with strict compliance requirements. You’re heavily regulated at every step—from research and development to product quality and patient safety.

These rules also extend to the enterprise resource planning (ERP) systems you use. If your system doesn’t meet strict US Food and Drug Administration (FDA) and/or local regulatory requirements, you can’t use it to run your pharmaceutical business. ERP system validation is required, and AX for Pharma can help.  

Why Your ERP System Validation Protocol Matters

Software validation is required by the FDA and other key regulators to ensure that the pharmaceutical, biotech, and medical device firms' chosen enterprise software systems are fit for purpose and capable of delivering the required outcomes. Regulatory bodies place these responsibilities on companies to improve product quality and consistency and increase patient safety.

ERP validation can be complicated. First, you must define and follow various complex procedures. Then, you must show that your system complies with regulatory requirements.

What’s more, you need to keep your system validated for its entire lifecycle. If you need to make changes to your system, you’re expected to validate it all over again. The AXP365 Validation Toolkit™ removes this burden and makes the process much easier. It gives you validation frameworks, templates, and documents based on Good Automated Manufacturing Practice 5 (GAMP 5) guidelines and recommendations.

The Traceability Matrix

A traceability matrix is a document that co-relates any User Requirements Specifications (URS) with its associated risk and testing document to check the completeness of the relationship.