Standard Operating Procedure for Data Integrity in Laboratory Information Management System

Purpose

The purpose of this SOP is to establish procedures for ensuring data integrity within the Laboratory Information Management System (LIMS) to support accurate and reliable laboratory testing and compliance with regulatory requirements.

Scope

This SOP applies to all personnel involved in the use, administration, and maintenance of the LIMS within the pharmaceutical manufacturing facility.

Responsibilities

• LIMS Administrator: Responsible for the configuration, administration, and security of the LIMS system, ensuring compliance with data integrity principles.
• Quality Control Analysts: Responsible for accurately entering, reviewing, and approving data in the LIMS, adhering to data integrity standards and laboratory procedures.
• IT Support Personnel: Responsible for providing technical support, maintaining system backups, and ensuring the security and availability of the LIMS infrastructure.

Procedure

1. Access Controls: Implement access controls within the LIMS to ensure that users have appropriate permissions based on their roles. Regularly review and update access rights as personnel responsibilities change.
2. Data Entry and Review: Follow established procedures for accurate data entry into the LIMS. Include mandatory fields, data verification checks, and electronic signatures where applicable. Review data for completeness and accuracy before approval.
3. Audit Trails: Enable and regularly review audit trails within the LIMS to track changes made to data. Investigate and document any unauthorized or unexpected changes promptly. Ensure that audit trails are secure and protected from tampering.
4. Data Backups: Establish and maintain a regular schedule for backing up LIMS data. Store backups in a secure location and periodically test the restoration process to ensure data availability in the event of system failures or data corruption.
5. Data Retention: Define and implement data retention policies within the LIMS. Archive or purge data according to established timelines and regulatory requirements. Ensure that archived data remains accessible for audits and investigations.
6. Electronic Signatures: Implement electronic signature functionality in the LIMS where required. Ensure that electronic signatures are unique, confidential, and protected from unauthorized use. Clearly define the circumstances under which electronic signatures are required.
7. System Validation: Periodically validate the LIMS software to ensure that it meets predefined specifications and performs as intended. Document the validation activities and maintain records for regulatory inspections.
8. Training: Provide training to personnel on the proper use of the LIMS, data entry procedures, and adherence to data integrity principles. Ensure that users understand the impact of their actions on data integrity.
9. Incident Reporting: Establish a process for reporting and investigating incidents related to data integrity in the LIMS. Document corrective and preventive actions taken in response to incidents. Implement improvements to prevent recurrence.
10. Periodic Review: Conduct periodic reviews of LIMS data and procedures to identify areas for improvement. Implement changes as necessary to enhance data integrity and system efficiency.

Abbreviations

No abbreviations are used in this SOP.

Documents

• LIMS Access Control Matrix
• Data Entry and Review Procedures
• Audit Trail Review Records
• Data Backup and Restoration Logs
• Electronic Signature Policy
• System Validation Documentation
• Training Records
• Incident Reports
• Periodic Review Reports

Reference

US FDA Guidance for Industry: Data Integrity and Compliance With CGMP

SOP Version

Version 1.0