Standard Opreating Procedure for Data Integrity Policy

The purpose of this Data Integrity Policy is to establish the principles and guidelines for ensuring the integrity of data generated, recorded, processed, and maintained throughout all stages of pharmaceutical manufacturing and related activities.

Scope

This policy applies to all personnel involved in data generation, recording, processing, and reviewing within the pharmaceutical facility, including operators, analysts, quality assurance personnel, and IT professionals.

Policy Statement

Our organization is committed to maintaining the highest standards of data integrity to ensure the accuracy, reliability, and authenticity of all data generated during pharmaceutical manufacturing processes. Data integrity is critical to meeting regulatory requirements, ensuring product quality, and safeguarding patient safety.

Key Principles

  1. Accuracy: All data must be accurate, reflecting the true and actual observations or measurements without intentional or unintentional errors.
  2. Legibility: All data must be recorded in a clear, legible, and permanent manner to ensure proper understanding and interpretation.
  3. Contemporaneousness: Data must be recorded at the time of the activity, reflecting real-time observations and events.
  4. Attributable: All data must be attributable to the person responsible for generating, recording, or modifying the data, with clear identification of personnel involved.
  5. Consistency: Data must be consistent throughout all records and systems, and any inconsistencies or discrepancies must be promptly addressed and documented.
  6. Completeness: All data must be complete, including necessary metadata, to provide a comprehensive and accurate record of the activity or process.
  7. Security: Electronic data must be protected with appropriate access controls to prevent unauthorized changes, deletions, or alterations.
  8. Documentation: All data must be properly documented, including the use of approved forms, templates, and electronic systems, following Good Documentation Practices (GDP).
  9. Review: Regular reviews and audits of data integrity practices must be conducted to identify and address potential vulnerabilities or areas for improvement.
  10. Training: Personnel involved in data generation and processing must receive adequate training on data integrity principles and procedures.
See also SOP for Data Backup and Recovery Procedures

Roles and Responsibilities

All personnel are responsible for adhering to the principles outlined in this policy. Data Stewards, Quality Assurance Personnel, and IT Professionals have specific responsibilities related to oversight, review, and maintenance of data integrity within their respective areas.

Enforcement

Non-compliance with this Data Integrity Policy may result in disciplinary action, including retraining, corrective actions, and, in severe cases, termination of employment.

Review and Revision

This Data Integrity Policy will be reviewed periodically to ensure its continued effectiveness and relevance. Any necessary revisions will be made in consultation with relevant stakeholders.

Approval

This Data Integrity Policy has been approved and authorized by [Name], [Title], on [Date].