Unmatched Enterprise Solutions for Pharma, Biotech, and Life Sciences

Pharmaceutical and biotech companies face challenges well beyond standard Enterprise Resource Planning (ERP) including complex operations, advanced project and quality management. AX for Pharma 365 is the solution designed to meet the needs of pharmaceutical companies, minimize customizations, and provide proven expertise from a trusted advisor.

Key Features

Inventory and Warehouse management
- Item approval workflow
- Approved warehouse list by item and storage conditions
- Control movements of goods based on rules and constraints
- Capability to use mobile devices to receive incoming batches and containers, transfer materials, execute adjustments
Full Traceability of Batches, Containers, and Serial Numbers
- Container/sub-batch management offers full traceability
- Tracking of material according to intended use (GMP, non-GMP, pre-clinical, animal health, etc.)
- Controlled substance management
Sales and Purchasing
- Manage approved customer lists by item, batch, country
- Reserve batches based on batch attributes and batch specifications by item and customer.
- Manage Approved Vendor and Manufacturer Lists by qualification status
Advanced Quality Management
- Quality order approval workflow 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
Manufacturing Execution System and 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
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 intended use code of components