Regulatory Compliance Software for Process Manufacturing and Distribution
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SWK Sage X3 Compliance Software Bundle
FDA Regulatory Compliance for Process Manufacturing and Distribution
The Only Turnkey Bundled Solution Available for Process Manufacturing FDA Regulation Compliance
SWK’s regulatory compliance solution empowers you to fulfill FDA regulations for food and beverage, cosmetics, pharmaceuticals and dietary supplements regarding electronic record management, lot and product-level serialization, and traceability requirements both internally and across the supply chain.
The Sage X3 solution bundle provides improved documentation, tracing capabilities, time-stamping, data security and distribution control to reduce the burden of adherence to new FDA regulations for process manufacturers and distributors.
Our FDA-compliant software solution powered by Sage X3 (formerly Sage Enterprise Management) combines Sage’s powerful Sage X3 business management solution with EDI on the seller and buyer’s side along with warehouse management and shipping automation to supercharge your supply chain and business. The Sage X3 bundle allows you to see where everything is when you need it, and gives you all the data you need to demonstrate compliance to the FDA, Canada Health, the ISO or any other regulatory agency.
Key Benefits
- A fully customizable business management solution
- Traceable, serialized data capturing and reporting
- Multi-carrier, multi-modal, and multi-platform shipping automation
- Seamless supply chain integration in one complete system
- Delivers the tools needed to ensure FDA compliance
Solution Components

- Solution captures data around serialized products
- Solution “traces” the products for use when an issue arises
- Manufacturer notifies stakeholders (the FDA, corporate executives, production line, wholesalers, distributors, and dispensers)

- EDI captures serialized data
- EDI communicates the purchase orders and invoicing transactions between the manufacturer and the supply chain

- Shipping and warehousing requirements
- Warehouse management software automates the “pick-pack-ship” process