Enterprise Management (formerly Sage X3) addresses the unique and specialized needs of pharmaceutical manufacturers.
FDA-registered manufacturers in industries such as pharmaceuticals and nutraceuticals have several unique challenges, including:
- Thinning pipelines
- Skyrocketing operating costs
- Calls for lower prices
- A greater regulatory burden
All of these challenges amount to an increasing pressure to maintain competitiveness while simultaneously complying with an increasing array of regulatory requirements.
Enterprise Management is fine-tuned to meet the specific needs of FDA-registered manufacturers, and by combining advanced manufacturing, distribution, warehousing, customer relationship management (CRM) and accounting functionality, Enterprise Management addresses the specific needs of:
- Formula management
- Weight calculations
- Potency management
- Full lot control and traceability
- Electronic signatures with transaction audit traceability
- Quality assurance and control
- Sophisticated pricing and contract management
- Sub-contracted operations and supply chain control
- Advanced order fulfillment and inventory allocation procedures
- Product packaging
Additionally, Enterprise Management helps FDA-registered manufacturers comply with the government reporting required for the Bioterrorism Act and 21 CFR Part II by providing a convenient and efficient way to gather and monitor relevant process information and, therefore, eliminating time-consuming manual procedures throughout the manufacturing process.
Also, in order to help minimize the risks of a product recall, Enterprise Management provides complete forward and backward lot traceability. A full audit trail and archive of historical transactions is maintained for multi-year periods. The fully integrated quality control process rigorously enforces inspections to required characteristics, operational tolerances or expected results.
Contact our Enterprise Management Team
If you would like to learn more about how Enterprise Management can help pharmaceutical manufacturers, please contact us online.