Click “Show More” below to read the answers to our most frequently asked questions (FAQs) about regulatory support.
A Regulatory Support File is a document containing both proprietary and non-proprietary information concerning one or more related BioProcess chromatography resins products marketed by GE Healthcare. The file may include information on performance, stability, extractable compounds, and analytical methods. It is an invaluable starting point for process development and validation, for preparation of standard operating procedures (SOPs) and quality control, and as support for clinical and marketing applications to regulatory agencies.
RSFs are continuously updated with new information. When the RSF to which you subscribe is updated, you will receive an email that new information is available.
A validation guide contains information such as product characteristics, material and requirement specifications, manufacturing process, qualification tests, or extractable compounds. VGs are available for single-use products such as Xcellerex bioreactors, WAVE Cellbag bioreactors, ReadyToProcess products and process-scale filters. VGs are continuously updated with new information. When the VG to which you subscribe is updated, you will receive an email that new information is available.
Validation Support Files for UNICORN software contain regulatory support documents that are an invaluable starting point for validation, preparing standard operating procedures (SOPs), and for supporting regulatory applications regarding production processes that utilize UNICORN software. When the VSF to which you subscribe is updated, you will receive an email that new information is available.
CCN is a web-based notification system concerning designated GE Healthcare Life Sciences products, where you subscribe to CCN for products of interest. When a notification is published for one of your subscribed products you will receive an email. CCN contains information regarding changes associated with the manufacture of products, in accordance with our standards.
Read more about the products concerned and our standards here.
RSF subscribers receive notifications pertaining to changes in the content of the RSF. CCN subscribers receive notifications pertaining to changes associated with the manufacture of products in accordance with our standards.
Read more about our standards here.
To avoid email notifications being classified as spam (unsolicited email), the system is designed so that the recipient must actively select to receive email notifications.
Due to the nature of the content in RSF/VSF/VG documents, a CDA is required from all subscribers of these types of documents. Users who only subscribe to CCN do not need a CDA.
Following the launch of the new Regulatory Support Application in 2013, there have been changes regarding the CDA:
- Users who only subscribe to CCN do not need a CDA. Please note that you may only subscribe to Change Control Notifications that apply to products that you have purchased and that your access to this site may be suspended if you misuse the site to gain access to information about other products than the ones you’ve purchased.
- A web-based version of the confidentiality agreement is available to give customers quicker access to regulatory support content. The confidentiality agreement will now be personal to each individual end-user. Each user must sign the confidentiality agreement on behalf of their company of employment. The confidentiality agreement must be renewed annually. Users that were already registered before the launch of the new Regulatory Support Application in November 2013, and whose company has an existing hard copy of the confidentiality agreement, will be able to use the hard copy version of the confidentiality agreement until the confidentiality agreement has expired.
- The CDA expiry date is displayed on your Profile page.
The first time you log into the Regulatory Support section after your agreement has expired, you will be prompted to renew the agreement on your Profile page. You will not be able to view or start any RSF/VG/VSF subscriptions until you have renewed your agreement and the renewal has been approved by GE Healthcare Regulatory Support.
The confidentiality agreement defines the use of the confidential information. Please consult your legal adviser.
Send an email to RegulatorySupportPS@ge.com to tell us who will be replacing whom. The new contact person has to be registered online before the RSF/VSF/VG or CCN subscriptions can be transferred. Please note that it is possible to register a generic company email address.
Please create a new account and log in and update your profile at Regulatory Support. Then inform us of the change at RegulatorySupportPS@ge.com and we will transfer your subscriptions.
Please note that it is possible to register a generic company email address.
You will need to renew your access once a year. To make sure your contact details are up-to-date, you will be asked to confirm/update your profile annually, thereby renewing your access. You will be notified by email when it is time to renew your access.
If you have lost your password for the Regulatory Support Web Application, please send an email to RegulatorySupportPS@ge.com for assistance.
The advantage of the RSF is that it gives first-hand information to the user. The DMF is used by vendors in order to protect trade secrets and its content is only revealed to FDA reviewers. The RSF can be used worldwide, while the DMF for products other than the active ingredient (e.g., chromatography resin) is only applicable in the U.S.
While the DMF contains manufacturing information, the RSF provides a list of raw materials but no description of the manufacturing process. Neither the DMF nor RSF is subject to any authority approval. The contents are only reviewed in connection with a specific product application.