Standard Operating Procedure for Data Transfer Procedures

Purpose

The purpose of this SOP is to establish procedures for the secure and accurate transfer of electronic data within the pharmaceutical manufacturing facility. This ensures data integrity, confidentiality, and compliance with regulatory requirements.

Scope

This SOP applies to all personnel involved in the generation, processing, and transfer of electronic data, including operators, IT personnel, and quality assurance personnel.

Responsibilities

• Data Owners: Responsible for identifying data to be transferred, ensuring data accuracy, and providing necessary information for the transfer process.
• IT Personnel: Responsible for implementing and maintaining secure data transfer mechanisms, addressing technical issues, and monitoring data transfer activities.
• Quality Assurance Personnel: Responsible for conducting periodic reviews and audits to ensure compliance with data transfer procedures and regulatory standards.

Procedure

1. Identification of Data to be Transferred: Collaborate with data owners to identify electronic data that needs to be transferred. Categorize data based on its sensitivity and criticality.
2. Data Transfer Plan: Develop a comprehensive data transfer plan outlining the objectives, scope, timelines, resources, and responsibilities. Include risk assessments and mitigation strategies.
3. Secure Transfer Mechanisms: Implement secure data transfer mechanisms, such as encrypted file transfers, virtual private networks (VPNs), or secure file-sharing platforms, to protect data during transit.
4. Data Mapping: Create a mapping document that clearly defines the structure and format of the data to be transferred. Include metadata and any transformation rules necessary for the transfer.
5. Transfer Authorization: Establish procedures for obtaining authorization before initiating data transfers. Verify the authenticity and authorization of data transfer requests. Maintain logs of transfer requests and approvals.
6. Validation of Data Transfer: Conduct validation checks on the transferred data to ensure its accuracy and completeness. Compare the transferred data with the source data to identify any discrepancies.
7. Documentation of Transfer Activities: Maintain detailed records of all data transfer activities, including the transfer plan, mapping document, authorization logs, and validation results.
8. Communication: Communicate the completion of data transfers to relevant stakeholders. Provide information on the location and accessibility of the transferred data at the destination.
9. Periodic Review: Periodically review data transfer logs to assess the ongoing effectiveness of transfer procedures. Address any identified issues and update the procedures accordingly.
10. Training: Provide training to personnel involved in data transfer activities to ensure a thorough understanding of the procedures and the importance of data integrity.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Data Transfer Plan
• Data Mapping Document
• Transfer Authorization Logs
• Transfer Validation Records

Reference

ISO/IEC 27001 – Information security management systems

SOP Version

Version 1.0