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.
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.
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.
There are many steps involved in the validation process, but our toolkit has what you need to complete them all.
The AXP365 Validation Toolkit™ includes test scripts for the AX for Pharma 365™ modules. It also has templates and samples for User Requirements Specification (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:
Our validation can help you complete your projects on time and within budget to meet client demands.
Aside from meeting your validation requirements, there are benefits to validating your ERP system.
The AXP365 Validation Toolkit™ offers many benefits for pharma companies looking to simplify their software validation processes.
Whether you’re in life sciences or biotech, compliance matters. The AXP365 Validation Toolkit™ takes the stress out of software validation so you can focus on growing your company. Our toolkit has everything required to comply with software validation guidelines, and our team can offer any extra support you need.
To order your toolkit or learn more about how AX for Pharma can support your company, contact us now.