§ 11.10 Controls for closed systems.

Law · 21 CFR 11.10 · eCFR as of 25 Sep 2026 · checked 30 Sep 2026 · Official source: ecfr.gov

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:

(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 suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.

(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. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.

(g) 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.

(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.

(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.

(k) Use of appropriate controls over systems documentation including:

(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.

(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.

How BatchGlow handles this

Electronic signatures cannot be deleted, and a signed formula or procedure changes only through a new version that an approved change request authorises. Signature events and master-data changes are written into a SHA-256 hash chain, so an altered or deleted entry breaks the chain visibly. A scale reading captured by BatchGlow Connector is accepted only from the scale's enrolled device, signed with that device's key.

What it asks for, in plain words

21 CFR 11.10: Whoever creates, changes, keeps or sends electronic records in a closed system uses procedures and controls that keep the records authentic and intact (and confidential where appropriate) and keep a signer from disowning a signed record. They include validation, copies for the FDA, protection for the retention period, limited access, audit trails, sequence and authority checks, device checks, trained people, written accountability policies and control of the system's documentation.
21 CFR 11.10(a): The system is validated: it is accurate, reliable and performs consistently as intended, and it can tell invalid or altered records.
21 CFR 11.10(b): The system can produce accurate and complete copies of records, readable by people and in electronic form, for the FDA to inspect, review and copy.
21 CFR 11.10(c): Records are protected so that they can be retrieved accurately and readily throughout their retention period.
21 CFR 11.10(d): Only authorized individuals have access to the system.
21 CFR 11.10(e): Secure, computer-generated, time-stamped audit trails record on their own the date and time of every entry and action that creates, changes or deletes a record. A change never hides what was recorded before. The audit trail is kept at least as long as the record itself must be kept and is available to the FDA.
21 CFR 11.10(f): Operational system checks enforce the permitted order of steps and events, as appropriate.
21 CFR 11.10(g): Authority checks ensure that only authorized individuals can use the system, sign a record electronically, reach its input or output devices, change a record or perform the operation at hand.
21 CFR 11.10(h): Device checks, such as checks of a terminal, determine as appropriate whether the source of data input or of an operational instruction is valid.

These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026, 5 Oct 2026. The text governs.