Operator entry checks Systems must include some mechanism that determines and records the validity of the source of any data entered manually. Education Persons who develop, maintain, or use electronic record and signature systems must have the education, training, and experience to perform their assigned tasks. Policies Written policies must be established and adhered to that hold individuals accountable and responsible for actions initiated under their electronic signatures. Systems documentation Systems must have adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. Revision and change control procedures to maintain an audit trail that documents the development and modification of systems documentation.
Many records require identification of the person or persons who created the record.
When performed electronically, this identification is termed an electronic signature. Uniqueness Each electronic signature must be unique to only one individual and must not be reused by or assigned to anyone else. The identity of an individual must be established before assigning that individual an electronic signature. FDA Notification Food manufacturers who desire to use electronic signatures as legally binding equivalent of traditional handwritten signatures must certify to FDA that they intend to do so by submitting a paper letter with a traditional handwritten signature to the agency. Certification Persons using electronic signatures must be able to provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.