If the site is relying on the sponsor system to create, modify, maintain, archive, retrieve, or transmit an electronic record required for FDA regulated clinical investigations and these records are considered the source for the site, this may be considered, “outsourced electronic service” and should be validated as appropriate.
In other words, if your site is relying on the sponsor system to be the system of record to meet FDA compliance, then Part 11 applies. However, most sponsor systems are intended to be helpful tools, and are not the sites system of record. Therefore it is not common for sponsors to send Part 11 documentation.
However, if the sponsor system is the system of record, then your site should obtain documentation that includes, but is not limited to, a description of standard operating procedures and results of testing and validation to establish that the outsourced electronic service functions in the manner intended.
