Enterprise Solutions for Pharma, Biotech and Life Sciences

Lifesciences organizations, pharmaceutical, biotech, and medical device manufacturers, face challenges and requirements that standard ERP systems cannot meet without costly customizations. AX for Pharma 365™ is a suite of solutions and enhancements that simplify complex operations and streamline project and quality management.

Key Features

Inventory and Warehouse management

• Item approval workflow
• Storage conditions/attributes and handling instructions
• Control movements of goods based on rules and constraints
• Container/batch/sub-batch management with full traceability
• Tracking of material according to intended use
• Controlled substance management

Sales and Purchasing

• Manage approved customer/vendor/manufacturer lists by item
• Reserve batches based on batch attributes and batch specifications by item/customer

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 Pharmacopoeias

Manufacturing Execution System and Weighing & Dispensing

• Real-time integration with scales and balances
• Theoretical and actual batch assay; automatic recalculation, rescaling, and reservation of components
• Use mobile devices to manage movements of material to and from dispensing booths

Production Control

• Manage rework and reprocessing activities and generate production Batch Records
• Manage Master Batch Records within the system
• Full traceability of consumed ingredients/components and manufactured products
• Integration of formulas with weighing & dispensing functionality
• Control of intended use code of components

Clinical supplies

• Streamline production flow; manage external/internal manufacturing and full lot genealogy
  
• Create hierarchical packaging with unique sequence numbers; print barcoded labels for delivery units
• Storage environment control, country-specific import and export permit regulations
• Manage logistics, track by expiration dates, and handle lot-tracking via mobile devices

Medical devices

• Automate Device Master Record tracking and documentation with Device History Record details
• Streamline manufacturing and automate end-to-end production processes with MES
• Proactive asset maintenance
• Trace devices history with PDM and PLM