Standard Operating Procedure for Data Integrity Incident Reporting

Purpose

The purpose of this SOP is to establish a standardized process for reporting and addressing incidents related to data integrity within the pharmaceutical manufacturing facility. This SOP aims to ensure the timely identification, documentation, and resolution of data integrity incidents to maintain the integrity of data generated in regulated activities.

Scope

This SOP applies to all personnel involved in data generation, processing, storage, and management within the pharmaceutical manufacturing facility.

Responsibilities

• Data Steward: Responsible for overseeing the incident reporting process, ensuring that incidents are appropriately documented, investigated, and resolved in a timely manner.
• Quality Assurance (QA) Personnel: Responsible for reviewing and assessing reported data integrity incidents, conducting investigations, and recommending corrective and preventive actions (CAPA) to prevent recurrence.
• Department Heads: Responsible for ensuring that their team members are aware of the incident reporting process and promptly report any incidents related to data integrity.

Procedure

1. Incident Identification: Promptly identify and recognize any potential incidents that may impact data integrity, including but not limited to unauthorized access, data manipulation, or system failures.
2. Incident Reporting: Report any identified data integrity incidents through the designated incident reporting system. Provide detailed information, including the nature of the incident, date and time of occurrence, individuals involved, and any potential impact on data integrity.
3. Initial Assessment: Upon receiving an incident report, conduct an initial assessment to determine the severity and potential impact on data integrity. Assign priority levels based on the criticality of the incident.
4. Incident Investigation: Form an investigation team, including representatives from relevant departments, to conduct a thorough investigation of the reported incident. Document the investigation process, findings, and root causes.
5. Corrective and Preventive Actions (CAPA): Develop and implement appropriate corrective actions to address the immediate issues identified during the investigation. Additionally, identify and implement preventive actions to mitigate the risk of recurrence.
6. Documentation: Maintain detailed documentation of the incident, investigation, and any actions taken. Ensure that the documentation is complete, accurate, and compliant with regulatory requirements.
7. Review and Approval: Submit the incident report, investigation findings, and proposed CAPA to the QA department for review and approval. QA personnel will assess the adequacy and effectiveness of the proposed actions.
8. Communication: Communicate the incident, investigation results, and implemented CAPA to relevant stakeholders, ensuring transparency and awareness of the actions taken to address data integrity incidents.
9. Periodic Review: Conduct periodic reviews of reported incidents and the effectiveness of implemented CAPA to identify opportunities for improvement in the incident reporting and resolution process.
10. Training: Provide training to all personnel involved in data-related activities on the incident reporting process, emphasizing the importance of reporting incidents promptly and accurately.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Incident Reporting Form
• Incident Investigation Report
• Corrective and Preventive Action (CAPA) Plan
• Communication Records
• Periodic Review Reports
• Training Records

Reference

Good Documentation Practices (GDP)

SOP Version

Version 1.0