Get General Provisions Subpart B

The stored electronic record must accurately reflect the information in the original record. The electronic record must be accessible and capable of being reproduced by all persons entitled by law or regulations to review the original record.

Equipment means tangible personal property (including information technology systems) having a useful life of more than one year and a per-unit acquisition cost which equals or exceeds the lesser of the capitalization level established by the non-Federal entity for financial statement purposes, or $5,000.

The 21 CFR Part 11 requirements outline criteria for electronic records, electronic signatures, and handwritten signatures on electronic records to be considered trustworthy, reliable, and comparable to paper records and signatures on paper.

Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt.

In the DOL, Non-Federal entity means a state, local government, Indian tribe, institution of higher education (IHE), for-profit entity, foreign public entity, foreign organization or nonprofit organization that carries out a Federal award as a recipient or subrecipient (see 2 CFR 200.1). [86 FR 22108, Apr. 27, 2021]

Uniform Guidance (2 C.F.R. Part 200): 2 C.F.R Part 200 establishes uniform administrative requirements, cost principles, and audit requirements for Federal awards to non-Federal entities.

eCFR :: 2 CFR Part 200 -- Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

What are 21 CFR Part 11 Audit Trail Requirements? The FDA 21 CFR Part 11 regulation requires the system used to manage electronic records to provide a secure, computer-generated, and time-stamped audit trail. Its purpose is to accurately record changes made to documents.

Part 11 is mainly about using electronic records and signatures in computer systems, while Annex 11 focuses on quality management of computerized systems. Part 11 requires electronic records and signatures to be trustworthy and reliable like paper records and handwritten signatures.