Copley’s FDA Extended ERP Solution

FDA regulated industries need an ERP solution that helps them remain compliant. Implementing an ERP system to meet business requirements that is validated in accordance with FDA regulations is a constant challenge.

The Copley FDA Extended ERP Solution is an extension of Infor CloudSuite Industrial to support the required compliance mandates for all FDA regulated industries. These extensions address the key functional areas where transaction records are required to support various standards that are critical for the system of record data and ensure clients remain in compliance with the 21 CFR Part 11 regulation.

Copley has designed, developed and deployed a solution and methodology to address the specific requirements of minimizing compliance risk, maintaining advanced security and electronic recording, and facilitating the validation process. Our solution ensures your organization is always poised for growth and expansion.

The Copley FDA Extended solution has several key features to ensure compliance. A key requirement of FDA compliance is the proper use of electronic records and signatures in the production and processes of goods manufactured by regulated firms. Our solution meets regulatory standards in offering DMR/DHR, full lot and serial tracking, approved vendor management, eSignature controls, CoA and CoC report for manufactured lots and integrated Quality Control System (QCS).

The FDA emphasizes regulated industries take a risk adverse approach to the development of their products and processes. For FDA regulated companies, validation of computer software is a critical component of maintaining compliance. While validation ensures the software’s intended use is substantiated and documented, the process can consume valuable resources, material costs, and expose a company to the risk of FDA audit non-compliance if not properly executed.

Copley understands the decisions clients face and we provide an Optional Validation Pack of program templates and test cases to minimize the client’s risks and improve the execution of their validation process. Our experience with FDA requirements and manufacturing best practices for clients has led to our development of these templates and an implementation methodology to ensure FDA compliance.