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 Regulatory Support & IQOQ/CCP Validation Documents
GE Healthcare provides services for Regulatory Support & IQOQ/CCP Validation Documents. Regulatory Support Files (RSF) and Change Control Notification (CCN) service for Bioprocess chromatography media and other products are available in our Regulatory Support area, click here to learn more.
GE Healthcare also has specially trained and certified engineers who perform Installation and Operational Qualification (IQ/OQ) and Change Control Protocols (CCP) in accordance with cGMP. These services include:
- On-site performance of IQ/OQ so users and operators of the system gain information about its technical design and function
- Verification and control of all documents and functions in the system, reported directly to the system owner
If you would like to learn more about innovative services that are helping to bring new levels of efficiency to companies just like yours around the world, please:
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