AXP365 Validation Toolkit™

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.

Stage 1: Process Design

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

Stage 2: Process Qualification

  • Execute Equipment / Utility / Facility Qualification
  • Run Process Performance Qualification

Stage 3: Process Monitoring

  • Monitor Critical Process Parameters as part of APR and Other Monitoring Programs

Why You Need the AXP365 Validation Toolkit™

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:

  • Boost efficiency
  • Cut validation costs
  • Reduce risks and errors

Our validation can help you complete your projects on time and within budget to meet client demands.

Benefits of ERP System Validation

Aside from meeting your validation requirements, there are benefits to validating your ERP system.

  • Efficiency: Validating your ERP helps you identify slow or time-consuming processes. You can identify ways to automate tasks to help speed up your operations.
  • Confidence: You’re not just meeting FDA rules. Our service helps you comply with other rules and regulations, including GxP guidelines.
  • Cost-effectiveness: You can save money on validation costs with our user-friendly, simple service.
  • Risk control: ERP validation helps to improve accuracy and cut back on the risks associated with manual validation processes.

Features of AXP365 Validation Toolkit™

The AXP365 Validation Toolkit™ offers many benefits for pharma companies looking to simplify their software validation processes.

  • Unlike regular ERP systems, our toolkit is specifically designed to support regulatory compliance. Our test scripts and templates improve efficiency and help you meet GxP guidelines.
  • Our services comply with GAMP 5 recommendations so you can be sure you’re doing everything possible to improve your validation and compliance efforts.
  • You will receive full support in meeting Computer System Validation (CSV) and Computer Software Assurance (CSA) guidelines.

ERP Software Validation from AX for Pharma

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