FDA Guidance on Electronic Services
If sponsors and other regulated entities outsource electronic services, who is responsible for meeting the regulatory requirements?
The sponsor (from 2017).
Documentation available in the Florence Library of FDA eRegulatory and eSource Guidance
Should sponsors or other regulated entities establish service agreements with the electronic service vendor?
Yes. Service agreements should include a clear description of the part 11 requirements and the roles/responsibilities of the electronic service vendor (from 2017).
Documentation available in the Florence Library of FDA eRegulatory and eSource Guidance
What should sponsors and other regulated entities have available on site to demonstrate that their electronic service vendor is providing services in accordance with FDA’s regulatory requirements?
They should have the specified requirements of the outsourced electronic service, a service agreement defining what is expected from the electronic service vendor, and the procedures for the electronic service vendor to notify the sponsor or other regulated entity of changes and incidents with the service (from 2017).
Documentation available in the Florence Library of FDA eRegulatory and eSource Guidance
What should sponsors and other regulated entities consider when deciding to validate outsourced electronic services that are used in clinical investigations?
Sponsors and other regulated entities should take a risk-based approach to validation for outsourced electronic services (from 2017).
Documentation available in the Florence Library of FDA eRegulatory and eSource Guidance
Under what circumstances would FDA choose to inspect the electronic service vendor?
Under certain circumstances. An example is if the criticality of the investigation requires inspection and the required records are not available from the sponsor or the clinical investigative site (from 2017).
Documentation available in the Florence Library of FDA eRegulatory and eSource Guidance
The summaries presented in our library are for informational purposes only, they are not for implementation in operations. Please consult official FDA guidance documents for operational use.
