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Electronic records and signatures rules

In a nutshell: Hold the closed-system, signature and password controls that make electronic trial records and signatures trustworthy

Use it when: Your trial captures records or signatures in a closed electronic system, and you want its Part 11 controls in one place. It does not cover open systems (11.30) or linking a signature to its record (11.70).

CC-PDM-1.0

Sources: 6
Rules: 79
Field: Clinical research
Authors: U.S. Food and Drug Administration

Electronic records and signatures rules

Contains 79 Rules

Confirm these elsewhere

Contains 79 Rules

21 CFR 11.10(a)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.10(b)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.10(c)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.10(d)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.10(e)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.10(f)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.10(g)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.10(h)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.10(i)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.10(j)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.10(k)From 21 CFR 11.10 — Controls for closed systems

21 CFR 11.50(a)From 21 CFR 11.50 — Signature manifestations

21 CFR 11.50(b)From 21 CFR 11.50 — Signature manifestations

21 CFR 11.100(a)From 21 CFR 11.100 — General requirements

21 CFR 11.100(b)From 21 CFR 11.100 — General requirements

21 CFR 11.100(c)From 21 CFR 11.100 — General requirements

21 CFR 11.200(a)From 21 CFR 11.200 — Electronic signature components and controls

21 CFR 11.200(b)From 21 CFR 11.200 — Electronic signature components and controls

21 CFR 11.300(a)From 21 CFR 11.300 — Controls for identification codes/passwords

21 CFR 11.300(b)From 21 CFR 11.300 — Controls for identification codes/passwords

21 CFR 11.300(c)From 21 CFR 11.300 — Controls for identification codes/passwords

21 CFR 11.300(d)From 21 CFR 11.300 — Controls for identification codes/passwords

21 CFR 11.300(e)From 21 CFR 11.300 — Controls for identification codes/passwords

Maintain and retain a certified copyFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Include associated metadata when providing copiesFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Maintain a record of authorized trial personnelFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure record changes do not obscure previous informationFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Retain audit trail in a searchable and sortable formatFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Record deliberate user actions in audit trailsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Document trainingFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Link electronic signatures to respective recordsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Link handwritten signatures to electronic recordsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Confirm these elsewhere

Use an alternative approach if it satisfies requirementsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure the study complies with the regulation for foreign clinical investigationsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Comply with the device regulation for foreign clinical investigationsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure data and results are credible and accurateFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Rely on validated processes to generate certified copiesFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Have written standard operating procedures for consistencyFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Apply the same retention period for certified copiesFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure authenticity, integrity, and confidentiality of dataFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Preserve electronic records and associated metadata in a secure and traceable mannerFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Put backup and recovery procedures in placeFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Maintain backup and recovery logsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure metadata are obtained and retained when systems are decommissionedFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Determine whether the communication method is appropriately secureFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure electronic systems are fit for purposeFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Validate electronic systems prior to useFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Evaluate and validate changes throughout the life cycleFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Document all changes to the systemFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure procedures and processes are in place to safeguard recordsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Base access controls on a risk assessmentFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Work only under own usernames and passwordsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Take steps to prevent unauthorized accessFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Conduct a risk assessment for security procedures and controlsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Put security safeguards in place and update themFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Use other safeguards like encryptionFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Address the continued validity of source data after breachesFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Conduct a risk assessment for electronic systemsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Protect audit trails from modification and disablementFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Make all audit trail documentation available for inspectionFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Apply a risk-based approach for retaining access informationFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Comply with applicable predicate rulesFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Put controls in place for system date and timeFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Limit the ability to change date or timeFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure necessary education, training, and experienceFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Provide relevant training for electronic systemsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure electronic records meet part 11 requirementsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Evaluate and select IT services based on data integrity safeguardsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Maintain access to study-related recordsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Develop and maintain a list of authorized data originatorsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure correct attribution of data obtained using DHTsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Design DHTs to prevent unauthorized changesFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Use personal credentials and avoid sharing themFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Instruct participants on DHT usageFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Transmit DHT data using a validated processFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Include first signing electronic components and subsequent restrictionsFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Ensure commercial off-the-shelf services conform to part 11From Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Design biometric electronic signatures to prevent misuseFrom Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers