Pharmaceutical companies face challenges that go well beyond standard enterprise resource planning (ERP) – complex operations, advanced project and quality management, compliance with stringent regulatory requirements, and many more.
AX for Pharma is designed to meet the full range of ERP needs for pharmaceutical companies. It minimizes customizations and implementation challenges with an ERP solution that is fully integrated with Microsoft Dynamics 365. The AX for Pharma solution includes core ERP functionality, Advanced Quality Management, GMP Plant Maintenance, Dispensing Module, Regulatory Compliance and Validation, CAPA Management, and Activity-Based Costing. Our expert, proven consulting services, and support from a knowledgeable advisor ensures the success of your implementation – and of your business in today’s intensely competitive market.
Integrated quality assurance include non-conformances management, quarantine, quality orders, sampling plans, reduced/skip testing, acceptance criteria, certificates of analysis, and batch records.
The module fully complies with GxP guidelines and regulatory requirements, in particular 21 CFR Part 11 and EU Annex 11.
This fully integrated module calculates the required quantities of the active ingredients and compensating materials.
Full integration also allows the selection of materials according to the FEFO/FIFO method.
Manufacturers achieve a high level of control and visibility of work-in-progress materials in GxP environments.
GMP Plant Maintenance offers the ideal solution for efficient administration and control over plant equipment and other assets.
With planned maintenance of production plants and equipment, GMP Plant Maintenance helps ensure timely, cost-effective production, optimal delivery performance, and full traceability for critical and regulated equipment.
GMP Clinical Supply
Accelerate your clinical supply chain with a single integrated ERP solution. Safely.
AX for Pharma for Clinical Supply helps you keep up with a constantly evolving Clinical Trial Industry, where new clinical trials are being launched at an ever-growing pace.
Corrective Action Preventive Action (CAPA) Management enables you to increase control, correct and prevent issues, measure the outcome and continuously monitor the system.
With our CAPA Management module your company can ensure compliance, effectiveness and efficiency.
Life Sciences companies are under enormous pressure to comply with complex regulatory requirements.
AX for Pharma’s Compliance module ensures your company achieves full compliance with international guidelines and regulations, including 21 CFR Part 11.