21 CFR 11.10(j): Policies for Using Electronic Signatures

If an FDA regulated computer system uses electronic signatures, the organization must have procedures which define practices for using electronic signatures within the organization.

Text of 21 CFR 11.10(j)

Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:

10.10(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

Interpretation

There should be policies that clearly state that the electronic signing is the same as a person’s handwritten signature and that all responsibilities that apply to handwritten signatures also apply to electronic signatures.

Implementation

An organization requires a clear policy on the use of electronic signatures, including a statement signed by all employees who will use electronic signatures that they understand an electronic signature is legally equivalent to a hand-written signature.

If you need more information or assistance with training on policies for using electronic signatures or assessing policies for using electronic signatures, please contact us to arrange consultation services.

Compare this requirement with Annex 11 Section 14., Electronic Signatures.

Frequently Asked Questions

Q: Are all employees required to sign our policy on the use of electronic signatures?
A: Only employees who will use a computer system with electronic signatures are required to be trained on the use of electronic signatures.

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