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Orientation in eight questions

21 CFR Part 11 Check for electronic records

In a few minutes, assess how robustly validation, copy and retention controls, access restriction, audit trails and electronic signatures are organised. The evaluation identifies initial priorities without collecting personal data.

A transparent quick check, not an audit

The check follows the subparts of 21 CFR Part 11: Electronic Records; Electronic Signatures as published in the eCFR. FDA additionally explains the scope in Part 11, Electronic Records; Electronic Signatures: Scope and Application. Scoring is explicit: Yes = 3, Partly = 2, Unknown = 1, No = 0. The result provides orientation and is neither an audit nor legal advice.

Evidence Review · 8 questions
Step 1 of 2
Step 1: Electronic records
01 · ValidationAre systems that create, modify, maintain or transmit electronic records validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records?

Requirement from 21 CFR 11.10(a): Controls for closed systems.

02 · Copies and retentionCan the system generate accurate and complete copies of records in human readable and electronic form suitable for inspection, and are records protected to enable accurate and ready retrieval throughout the records retention period?

Requirement from 21 CFR 11.10(b) and 11.10(c).

03 · Access controlIs system access limited to authorized individuals?

Requirement from 21 CFR 11.10(d).

04 · Audit trailDoes the system use secure, computer-generated, time-stamped audit trails that independently record the date and time of operator entries and actions that create, modify or delete electronic records, and is that documentation retained at least as long as the subject electronic records and available for agency review and copying?

Requirement from 21 CFR 11.10(e).

Step 2: Operational checks and electronic signatures
05 · Operational, authority and device checksAre operational system checks, authority checks and, as appropriate, device checks in place to enforce permitted sequencing of steps and events and to ensure that only authorized individuals can use the system, electronically sign a record, access input or output devices, alter a record, or perform the operation at hand?

Requirement from 21 CFR 11.10(f), 11.10(g) and 11.10(h).

06 · Closed and open systemsAre the closed-system controls of § 11.10 applied, and, where open systems are used to create, modify, maintain or transmit electronic records, are additional measures such as document encryption and appropriate digital signature standards used to ensure authenticity, integrity and confidentiality?

Requirement from 21 CFR 11.10 and 21 CFR 11.30: Controls for open systems.

07 · Signature manifestation and linkingDo signed electronic records contain the printed name of the signer, the date and time when the signature was executed, and the meaning associated with the signature, and are electronic signatures linked to their respective electronic records so that they cannot be excised, copied or otherwise transferred to falsify an electronic record by ordinary means?

Requirement from 21 CFR 11.50: Signature manifestations and 21 CFR 11.70: Signature/record linking.

08 · Electronic signaturesAre electronic signatures unique to one individual and not reused or reassigned, and do non-biometric signatures employ at least two distinct identification components (such as an identification code and password), with controls that maintain uniqueness?

Requirement from 21 CFR 11.100, 11.200 and 11.300.

Regulatory context and target groups

For operators

Pharmaceutical and manufacturing organisations gain an initial view of validation, audit trails, access controls and electronic signatures before an FDA inspection.

For CSV and system owners

The check helps prioritise Part 11 gaps on laboratory, manufacturing and quality systems: alongside the Annex 11 Check.

Develop Part 11 with robust evidence

Discuss CSV, a GAP analysis or electronic signatures with our advisory team.

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