AXP365 Advanced Quality Management™

Enterprise Resource Planning (ERP) and Laboratory Information Management System (LIMS) — A single, integrated solution for the Pharmaceutical Industry

Bringing potentially life-saving or life-altering medicines to market consistently to a safe standard is no easy feat. From the Code of Federal Regulations (CFR) to life sciences Good Manufacturing Practice (GMP) guidelines, you must follow numerous rules and any errors can cause you to fall short of your compliance requirements.

Even small errors in quality control can be disastrous, involving expensive recalls and significant fines, as well as negative publicity. How can you avoid these consequences? By streamlining, integrating, and automating your life sciences quality management system.

Life Sciences GMP and the Benefits of Quality Management

Quality control is critical throughout every aspect of the pharmaceutical, biotech, and medical device manufacturing process, from the initial stages to production and distribution.
Traditional approaches see pharmaceutical, biotech, and medical device companies investing significant time, resources, and money to implement a wide range of add-on solutions. Such technologies include Laboratory Information Management Systems (LIMS) and, Enterprise Resource Planning (ERP), while maintaining compliance with regional and international regulations, GMP guidelines, and customer requirements.

With AXP365 Advanced Quality Management™, though, the tools you need are all in one place. You will no longer require a separate LIMS solution for pharma and life sciences QMS, for example. Instead, you can access every workflow you need from one centralized platform.

Quality Management systems in pharma are vital. Learn how our solution supports Quality Management to ensure product excellence and regulatory compliance
For more information, please download our eBook:
How Life Science Companies Can Improve Their Market Value

A Comprehensive Approach to Quality Management Systems in the Life Sciences Sector

Offered as part of AX for Pharma’s end-to-end ERP solution, the AXP365 Advanced Quality Management™ module for the pharmaceutical industry allows you to easily manage quality control and sampling for critical raw materials and manufactured products, while accurately tracking each product unit within a batch.

Furthermore, the module enables you to integrate approved customer and manufacturer lists into the purchasing process, or setting tight control limits to identify quality issues as soon as they occur. The module also offers extensive reporting, configurable approval workflows, a complete audit trail, and an electronic signature capability that complies with 21 CFR Part 11 standards.

Integrated Life Sciences QMS and LIMS

Our ERP software for the pharmaceutical industry includes a comprehensive set of quality control functionalities, built on Microsoft technology, which helps you avoid the pitfalls of costly standalone add-ons that are difficult to upgrade and maintain. One fully integrated system means a single source of truth, which can provide greater transparency and productivity.


Here’s how AXP365 Advanced Quality Management™ can support your life sciences GMP compliance and help you streamline your operations:

  • Cost reduction: Our pharma ERP software provides the solutions you need in one place – helping you control costs by eliminating the need for expensive add-ons.
  • Increased transparency: Our modules allow you to record all your key data, which simplifies the auditing process.
  • Enhanced compliance: From life sciences GMP guidelines to country-specific regulations, AXP365 Advanced Quality Management™ is uniquely designed to support your compliance efforts and adherence to industry-accepted standards around the world.
  • Improved accuracy: Manual, paper-based processes are cumbersome and prone to errors. Our software enables you to digitize every piece of data, improving accuracy and reducing the likelihood of communication errors arising.

Contact our team to discover more benefits of AXP365 Advanced Quality Management™.

AXP365 Advanced Quality Management™ Key Features

At AX for Pharma, we understand just how critical good quality control procedures are to your company’s success:

  • Sample management: From selecting samples to tracing their destination, our dedicated workflow simplifies the entire process.
  • Test Results – Enter, review, and approve quality results, which are automatically compared to test specifications
  • Batch management: Manage every aspect of your batches with a user-friendly, comprehensive workflow.
  • Project management: Our pharma ERP software comes with the added benefit of accounting tools for laboratory services.
  • Work scheduling: Track output and simplify lab skill management with automated scheduling and work tracking.
  • Compliance: Improve your compliance with 21 CFR Part 11 and EU Annex 11 using our dedicated laboratory information management software.
  • Supplier qualification: Track, monitor, and record your supplier qualifications for increased transparency
  • Quality reporting – Produce reports and KPIs directly from the ERP system or via integration with Power BI and Excel

See Our Advanced Quality Management Solution in Action

There’s no better way to understand how our pharma ERP software can help your company than by seeing how it works. Please watch this video to discover how AX for Pharma can help you meet industry demands and improve operational efficiency.

Contact us to discuss how to integrate our Life Sciences Quality Management System into your operations.