AX for Pharma

AX for Pharma: a complete solution that combines proven software and expertise from a trusted advisor. Pharmaceutical companies face challenges well beyond standard Enterprise Resource Planning (ERP), including complex operations, advanced project and quality management. AX for Pharma is the solution, designed to meet the needs of pharmaceutical companies, minimize customizations and provide proven expertise from a trusted advisor. Key features:

1. Inventory and Warehouse management
   • Item approval workflow.
   • Approved Warehouse List by item and storage conditions.
   • Control movements of goods based on rules and constraints (storage conditions, storage restrictions, use code, controlled substances).
   • Capability to use mobile devices to receive incoming batches and containers, transfer material across sites, execute inventory adjustments.
2. Full traceability of batches, containers and serial numbers
   • Container/sub-batch management offers full traceability, including batch lifecycle and status changes.
   • Tracking of material according to its intended use (GMP, non-GMP, pre-clinical, animal health, etc.).
   • Controlled substance management.
3. Sales and Purchasing
   • Manage Approved Customer Lists by item, batch, and country.
   • Reserve batches based on batch attributes and batch specifications by item and customer. Secure Qualified Person approval for shipments.
   • Manage Approved Vendor and Manufacturer Lists (AVL, AML) by qualification status.
4. Advanced Quality Management
   • Quality order approval workflow including peer review, quality control and quality assurance approvals secured by electronic signature.
   • Stability studies and environmental control.
   • Sample management and statistical sampling plans.
   • Certificates of Analysis by item/customer.
   • Test criteria based on US and EMA Pharmacopeias.
5. Manufacturing Execution System/Weighing & Dispensing
   • The Weighing & Dispensing module offers real-time integration with scales and balances.
   • Assay management includes theoretical and actual batch assay, along with automatic recalculation/rescaling and reservation of components.
   • Fully integrated with handheld devices to manage movements of material to and from weighing and dispensing booths.
6. Production Control
   • Manage rework and reprocessing activities. Generate production Batch Records.
   • Save time and reduce paper-based activities by managing master batch records within the system.
   • Full traceability of consumed ingredients/components and manufactured products.
   • Integration of formulas with weighing and dispensing functionality.
   • Control of the intended Use Code of components.