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

AX for Pharma 365™

Видавець: AX for Pharma