21 CFR Part 11 Electronic Records Compliance

Electronic Records and Electronic Signatures Compliance. All electronic records and electronic signatures created, modified, maintained, archived, retrieved, or transmitted under this system shall comply with the requirements of Title 21 of the Code of Federal Regulations, Part 11 (21 CFR Part 11). The system shall employ procedures and controls designed to ensure the authenticity, integrity, and confidentiality of electronic records, including: (a) validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records; (b) the ability to generate accurate and complete copies of records in both human-readable and electronic form; (c) protection of records to enable their accurate and ready retrieval throughout the records retention period; (d) limiting system access to authorized individuals; (e) use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records; and (f) use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. Electronic signatures shall be unique to one individual and shall not be reused by or reassigned to anyone else.