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.
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.
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.
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:
Contact our team to discover more benefits of AXP365 Advanced Quality Management™.
At AX for Pharma, we understand just how critical good quality control procedures are to your company’s success:
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.
