SMB Validation

If using a 'hybrid system' approach to e-signatures, how do you link the handwritten signature to the e-record?

Since Part 11 does not require that electronic records be signed using electronic signatures, e-records may be signed with handwritten signatures that are applied to electronic records or handwritten signatures that are applied to a piece of paper. If the handwritten signature is applied to a piece of paper, it must link to the electronic record. The FDA will publish guidance on how to achieve this link in the future, but for now it is suggested that you include in the paper as much information as possible to accurately identify the unique electronic record (e.g., at least file name, size in bytes, creation date and a hash or checksum value.) Hoverer, the master record is still the electronic record. Thus, signing a printout of an electronic record does not exempt the electronic record from Part 11 compliance.