Standard Operating Procedure for Data Integrity in Computerized Systems Validation

Purpose

The purpose of this SOP is to establish policies and procedures to ensure data integrity in computerized systems validation (CSV) within the pharmaceutical manufacturing facility. This SOP aims to comply with regulatory requirements and maintain the accuracy and reliability of data generated by computerized systems.

Scope

This SOP applies to all personnel involved in the design, development, testing, implementation, and maintenance of computerized systems used in the pharmaceutical manufacturing facility.

Responsibilities

• Validation Manager: Responsible for overseeing the implementation of data integrity practices in CSV, ensuring compliance with regulatory standards.
• IT Validation Team: Responsible for executing validation activities, including risk assessments, testing, and documentation, to ensure the integrity of data generated by computerized systems.
• Quality Assurance Personnel: Responsible for providing oversight and ensuring that CSV activities adhere to data integrity principles and regulatory requirements.

Procedure

1. Risk Assessment: Conduct a risk assessment to identify and assess potential risks to data integrity associated with the computerized system. Consider factors such as system complexity, criticality, and impact on product quality and patient safety.
2. Data Mapping: Clearly define data elements generated or processed by the computerized system and map their flow throughout the system. Identify critical data and establish controls to ensure its accuracy, completeness, and reliability.
3. User Access Controls: Implement user access controls to ensure that only authorized personnel have access to the computerized system. Define user roles and permissions based on job responsibilities and the principle of least privilege.
4. Audit Trails: Activate and review audit trails within the computerized system to track changes made to data. Regularly review and archive audit trail records, ensuring they are secure from unauthorized access or tampering.
5. Data Backup and Recovery: Establish regular data backup and recovery procedures to prevent data loss. Verify the effectiveness of backup and recovery processes through periodic testing. Ensure that backup data is stored securely.
6. Change Control: Implement a change control process to manage changes to the computerized system. Ensure that changes are documented, tested, and approved before implementation, with a focus on maintaining data integrity.
7. Periodic Review: Conduct periodic reviews of the computerized system to ensure ongoing compliance with data integrity requirements. Address any identified issues or deviations promptly and document corrective actions taken.
8. Training: Provide training to personnel involved in the use, administration, or oversight of the computerized system. Ensure that users understand the importance of data integrity and their roles in maintaining it.
9. Documentation: Maintain comprehensive documentation for the computerized system, including user manuals, validation documentation, and standard operating procedures (SOPs). Ensure that documentation is kept up-to-date and accessible for regulatory inspections.
10. Vendor Management: Establish procedures for the selection and management of vendors providing computerized systems. Verify that vendors comply with data integrity principles and provide necessary documentation for validation.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Risk Assessment Report
• Data Mapping Documentation
• User Access Control Matrix
• Audit Trail Review Records
• Data Backup and Recovery Procedures
• Change Control Records
• Periodic Review Reports
• Training Records
• Documentation for Computerized System
• Vendor Management Records

Reference

ICH Q9 – Quality Risk Management

SOP Version

Version 1.0