The QMS documentation needs to specify how all records are generated (and by whom) and how and where they are stored and archived. This applies to electronic as well as paper records.

Records must be generated immediately information is obtained, to prevent error.

Records must not be erased, or altered in such a way that the previous form of the record is not legible. For example, correction fluid must not be used.

Alterations to records must be authorised, typically with the initials of an authorised staff member making the alteration.