FDA Validation Support & Services for Implementing an ERP Solution

Implementing an ERP solution for organizations that fall under FDA regulations must go through a validation process. The validation determines, defines, governs and documents the formal testing of Good Manufacturing Practices (GMP) and relevant activities pertaining to the definition, production and delivery of regulated products and services.

The Copley Consulting Group’s FDA Validation Support

Copley supports our FDA regulated clients by providing validation plan preparation, traceability matrix definition, operation and performance test cases, technical installation verification, IOPQ protocol and summary reports, as well as a validation summary report.

Copley’s Risk Minimization with Blended Validation & ERP Deployment

While validation ensures that your use of the software is substantiated and documented, the validation process can consume your company’s valuable resources. When implementing a new ERP solution to improve your company’s business processes, it is essential that your FDA validation and your ERP Go-Live are on the same concurrent timeline.

FDA Validation Tools

Copley’s FDA Extended ERP solution ensures validation of the software’s intended use while exposing a company to their risk of FDA audit non-compliance if not properly executed. 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.

Process Templates

If your Regulatory personnel have experience in leading an FDA Validation project that included the back-end ERP software, then you can leverage your internal resources by having them take the lead in the process. To support their efforts and to maximize their efficiency, the Copley FDA Validation Templates provide guidance to streamline their workload.

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OPQ Scripts

The extensive, detailed documentation required in support of your OPQ report can be burdensome to your organization, with errors requiring significant rework. The operational and performance validation scripts, developed specifically for the Infor Cloudsuite solution, help you reduce the effort, and lessens the risk of errors by facilitating compliance with these stringent requirements.

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Concurrent FDA Validation
& ERP Deployment Methodology

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