Copley FDA Extended Solution
Copley FDA Extended Solution is an ERP platform for FDA-regulated industries, offering compliance tools, validation services, and templates to reduce audit risk and streamline product commercialization. Built on Infor SyteLine®, it helps ensure FDA compliance with greater efficiency.
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Copley FDA Extended Solution Overview
Copley FDA Extended Solution, built on Infor SyteLine® for Life Sciences and Medical Devices, is designed to meet the complex regulatory demands of FDA-regulated industries. As Infor’s preferred ERP solutions partner for the medical device sector, Copley provides tools that streamline compliance, mitigate audit risk, and accelerate product commercialization. It includes validated ERP and concurrent validation services, using pre-configured templates and OPQs tailored to FDA standards. This comprehensive solution supports manufacturers in ensuring the software’s intended use while minimizing non-compliance exposure, enabling efficient and secure operations.
Features
Device Master Record (DMR) & Device History Record (DHR) Management
Full Lot & Serial Traceability
Electronic Signature Controls
FDA Validation Tools
Copley FDA Extended Solution Pricing Overview
Copley FDA Extended Solution Score
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FAQs
It’s tailored for FDA-regulated industries, including medical devices, pharmaceuticals, organ regeneration, and compound pharmaceuticals.
Yes, it includes features like electronic signatures and audit trails to support compliance with FDA 21 CFR Part 11.
No, the solution does not offer a free trial or free version.
Support is available 24/7 via email, phone, knowledge base, FAQs/forum, and live chat.
The solution can be deployed both as a cloud-hosted service and on-premise, depending on organizational needs.
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