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Hybrid system for consent form and other signed records

October 9th, 2009
Officially Part11 does not require that electronic records be signed using electronic signatures.
So electronic records may be signed with handwritten signatures that are applied to electronic records or handwritten signatures that are applied to a piece of paper that is link to the record.
The FDA is planned to 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. As minimum that should include file name, byte size, creation date and a hash or checksum value such as
CRC (Cyclic Redundancy CheckOfficially Part11 does not require that electronic records be signed using electronic signatures.
So electronic records may be signed with handwritten signatures that are applied to electronic records or handwritten signatures that are applied to a piece of paper that is link to the record.
The FDA is planned to 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. As minimum that should include file name, byte size, creation date and a hash or checksum value such as
CRC (Cyclic Redundancy Check).
Part11 does not require that electronic records be signed using electronic signatures.
So electronic records may be signed with handwritten signatures that are applied to electronic records or handwritten signatures that are applied to a piece of paper that is link to the record (referred to as hybrid).
The FDA is planned to 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. As minimum that should include file name, byte size, creation date and a hash or checksum value such as CRC (Cyclic Redundancy Check).

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