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checklist computerized systems and electronic data in clinical trials

Verify that the computerized system is validated according to regulatory requirements.

Document validation protocols and results.

Ensure that the system is capable of performing intended functions.

Implement measures to ensure data accuracy, completeness, and consistency.

Establish audit trails to track data changes.

Conduct regular data quality assessments.

Ensure that access controls are in place to protect sensitive data.

Implement user authentication and role-based access.

Regularly review and update security policies.

Familiarize with relevant regulatory guidelines (e.g., FDA, EMA).

Ensure that the system complies with 21 CFR Part 11 requirements.

Maintain documentation for regulatory inspections.

Provide training for all users on the computerized system.

Assess user competency regularly.

Document training sessions and user evaluations.

Establish a data backup plan to prevent data loss.

Test backup and recovery procedures periodically.

Store backups securely and ensure they are easily retrievable.

Implement a change control process for system modifications.

Document all changes, including rationale and impact assessments.

Review and approve changes by relevant stakeholders.

Develop a procedure for reporting and handling system incidents.

Document incidents and their resolutions.

Analyze incidents to prevent future occurrences.

Schedule regular maintenance for the computerized system.

Ensure that technical support is available for users.

Document maintenance activities and any issues encountered.

Gather user feedback on system performance.

Conduct periodic reviews of system effectiveness.

Implement improvements based on feedback and performance evaluations.

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