About Copley FDA Extended solution
Copley FDA Extended solution is a compliance software from Copley Consulting Group that helps small- to mid-size medical device manufacturers reduce FDA compliance risk during ERP implementation. It combines FDA Extended Solution, Infor Syteline, and Infor CloudSuite™ Industrial to provide essential regulatory support. Additionally, it includes Infor CloudSuite™ Distribution and Infor CloudSuite™ Food & Beverage for industry-specific applications. This solution is designed to address key compliance requirements, ensuring manufacturers maintain adherence to FDA regulations while managing their enterprise resources effectively. Key capabilities: DMR/DHR Full Lot & Serial Traceability Compliance Reporting ERP Integration Risk Management Best for: medical device manufacturers that need to navigate FDA compliance within their ERP systems.
Copley FDA Extended solution Details
Copley FDA Extended solution's In-App Market Place
Does Copley FDA Extended solution have an in-app market place?
Yes
How many Mini-Apps in the marketplace?
1
Mini Apps
N/A
Pricing Options
Accepted Payment Currencies
USD ($), EUR (€), GBP (£), JPY (¥), AUD ($), CAD ($), CHF (Fr), CNY (¥), SEK (kr), SGD ($), NZD ($), HKD ($)
Pros & Cons
- 1. Specifically designed for enhanced compliance within FDA-regulated industries.
- 2. Offers robust management of critical device documentation like DMR and DHR.
- 3. Provides comprehensive tracking of all components through lot and serial traceability.
- 4. Streamlines approval workflows with integrated electronic signature controls.
- 1. Highly specialized for FDA compliance, potentially limiting its broader use.