Bringing potentially life-saving or life-altering medicines to market consistently to a safe standard is no easy feat — especially when guidelines and regulations vary across different countries. Small errors in quality control can result in disastrous consequences, involving expensive recalls and significant fines, as well as negative publicity.
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 and practices include Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP), and Good Manufacturing Practice (GMP) guidelines while maintaining compliance with regional and international regulations and customer requirements. With AXP 365 Advanced Quality Management™, this is all in one place.
Offered as part of AX for Pharma 365™’s end-to-end ERP solution, the AXP 365 Advanced Quality Management™ module (LIMS) allows you to easily manage quality control and sampling for critical raw materials and manufactured products while accurately tracking each product and product unit within a batch. Furthermore, the module enables you to integrate approved customer and manufacturer lists into the purchasing process, setting tight process 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.
This comprehensive set of quality control functionalities, built on Microsoft technology, 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 — and this can provide greater transparency and productivity for your laboratory.