Manufacturers of FDA Regulated products are faced with an evolving set of regulatory standards with which they must comply. Meeting these government regulations adds cost and risk to the business. The Copley FDA Extended ERP Solution based on Infor CloudSuite Industrial (CSI) is built to specifically address the nuanced requirements for this regulated sector. With enhanced lot and serial traceability, the solution supports full Device History Record (DHR) creation and querying, complemented by a totally integrated and stringently maintained Device Master Record (DMR). Recognizing the critical sensitivity, privacy, and security of data, the FDA Extended solution helps to maintain proper data governance with complete audit trail capability.

Maintaining strict quality management and detailed product documentation to meet customer specifications and regulatory requirements is necessary in an FDA regulated industry. In addition, special production techniques, materials, and packaging for medical products force companies to keep stringent control over engineering and shop floor operations. With the proper ERP system in place, Copley’s clients have the resources to create detailed work orders and access to the real-time data in order to maintain tight control over their manufacturing processes. Plus, they get accurate, reliable information about operations, customer histories, and costs to keep up with regulations and bring products to market quickly.

In an FDA compliant IT infrastructure, Copley’s FDA regulated clients benefit from well-established protocols and validation scripts developed by Copley Consulting that meet regulatory requirements for computer systems in compliance with the FDA’s 21 CFR Part 11. Rather than acting as isolated functional units, the latest set of FDA rules necessitate compliance from a systems-oriented approach.

The FDA regulated industries we work with vary from medical device manufacturers to food and beverage manufacturers. Copley Consulting works with a diverse set of industries to ensure their FDA compliance.