Standard Operating Procedure for Data Integrity Assurance

1) Purpose

This SOP outlines the procedures to ensure data integrity in pharmaceutical manufacturing and documentation practices to comply with regulatory requirements and maintain accuracy, completeness, and reliability of data.

2) Scope

This SOP applies to all personnel involved in generating, recording, reviewing, and managing data within the pharmaceutical facility to prevent data manipulation, falsification, or loss.

3) Responsibilities

Quality Assurance (QA) is responsible for implementing and overseeing data integrity practices. All personnel are responsible for adhering to data integrity principles outlined in this SOP.

4) Procedure

4.1 Data Generation and Recording

1. Ensure data is generated accurately, contemporaneously, and directly recorded at the time of observation or action.
2. Use approved and validated electronic systems or paper-based forms for data recording.

4.2 Data Review and Approval

1. Assign personnel responsible for data review and approval based on documented procedures and role responsibilities.
2. Review data promptly to verify accuracy, completeness, and compliance with procedures before approval.

4.3 Data Access and Security

1. Control access to data systems and records based on user roles and responsibilities.
2. Implement electronic and physical controls to prevent unauthorized access, changes, or deletions.

4.4 Data Backup and Recovery

1. Establish procedures for regular data backup to secure and reliable storage locations.
2. Verify backup integrity through periodic testing and ensure data recovery procedures are in place.

4.5 Audit Trails and Version Control

1. Enable audit trails in electronic systems to track changes, deletions, and access to data.
2. Maintain version control for critical documents and data records to ensure traceability and accountability.

4.6 Data Retention and Archival

1. Define retention periods for data and records based on regulatory requirements and business needs.
2. Archive data securely to ensure accessibility, readability, and integrity throughout the retention period.

4.7 Training and Awareness

1. Provide training on data integrity principles and procedures to all personnel involved in data handling and management.
2. Conduct periodic reviews and assessments to ensure ongoing compliance and awareness.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Data Integrity Policy, Data Handling Procedures, Training Records

7) Reference, if any

Regulatory guidelines such as FDA Data Integrity and Compliance with cGMP Guidance for Industry, EU GMP Annex 11 Computerized Systems, WHO Good Data and Record Management Practices

8) SOP Version

Version 1.0