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Regulatory Support
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Welcome to Regulatory Support

GE Healthcare Life Sciences provides regulatory support to customers of our BioProcessTM products and services.
The information is available after signing a confidentiality agreement, as some of the information contained is proprietary.

Regulatory Support Documentation for BioProcess products (brochure)
Change Control Notification Service for Bioprocess products (brochure)

To get started; instructions here

Our offering includes:

Regulatory Support File (RSF) for BioProcess chromatography media. Find more details on content here.
Validation Guide for Single-use products, such as Process-scale filtration equipment, WAVE Cellbag bioreactors and ReadyToProcess products. Find more details on content here.
Validation Support File (VSF) for UNICORNTM software. Find more details on content here.

A single payment per RSF/Validation Guide/VSF is charged at ordering.


Change Control Notification (CCN) service
CCN gives information on changes in accordance with our change control process and change control process for BioProcess instruments and columns. It is free of charge and currently available for the following BioProcess products:

  • Chromatography media
  • ReadyToProcessTM products NEW!
  • WAVE CellbagTM bioreactors NEW!
  • Process-scale filtration products NEW!
  • Chromatography instruments and columns NEW!

    • Additionally CCN service is available for customers in regulated environments regarding Biacore products:
  • BiacoreTM consumables NEW!
  • Biacore instruments and software
    To access the latest software version you also need to sign up at http://www.biacore.com/lifesciences/login/login/index.html and register your Biacore Product Key.
    Biacore change control process
    Biacore consumables change control process

    As a subscriber to regulatory support, you will receive e-mail notifications when RSF, VSF or Validation Guides are updated with new information or when a new CCN is published.You may invite up to 10 readers to share your subscriptions
    To order RSF, VSF, Validation Guide or CCN subscriptions, click on Subscription ordering.
    For subscription to CCN for customer specific products, please contact us at RegulatorySupportPS@ge.com.


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