Documentation for products used in regulated environments
Support for products used in regulated environments
With a regulatory support account, you get access to product documentation invaluable to process development and validation. The documentation is free of charge and is also critical for preparation of standard operating procedures (SOPs), quality control as well as clinical and marketing applications to regulatory agencies.
The subscription service helps you stay aware of when the regulatory support documents are updated. You can also subscribe to Change Control Notifications (CCN) to get notified of important changes to products used in regulated environments.
A few things to keep in mind:
- Register with a company email address. A personal company email address is required for regulatory support documents. For the CCN service we recommend using a generic company address.
- Once logged in, select the subscriptions you want
- Forgot your password? Just contact us
- Need help to get started? Download the instructions .
Regulatory support documentation
With a subscription to regulatory support documentation, you can access these documentation types:
- Regulatory Support Files (RSF) for BioProcess chromatography resins
- Validation Guides for single-use products, such as Xcellerex systems, Cellbag bioreactors, as well as ReadyToProcess products and process-scale filters
- Validation Support Files (VSF) for software
- Extractables Summaries for certain BioProcess hardware, like AxiChrom columns and pilot- and process-scale ÄKTA systems
Change Control Notification (CCN) service
Receive important information on changes through our CCN subscription service for products used in regulated environments. The CCN service provides information on changes in accordance with our change control processes.FIND OUT MORE