Signature manifestation (11​.50)

Electronic records must include information associated with each electronic signature applied to the record. This information must be controlled to the same degree as the electronic records and all aspects of the signature will be included in the human readable form of the electronic record.

The required signature information includes:

• Printed name of the signer

• Date and time when the signature was applied

• Assigned role of the person applying the signature (e.g. author, reviewer, approver)