Standard Operating Procedure for Data Migration

Purpose

The purpose of this SOP is to establish procedures for the controlled migration of electronic data from one system or platform to another within the pharmaceutical manufacturing facility. This ensures data integrity, accuracy, and compliance with regulatory requirements.

Scope

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

Responsibilities

Data Owners: Responsible for identifying data to be migrated, ensuring data accuracy, and providing necessary information for the migration process.
IT Personnel: Responsible for planning and executing the data migration process, ensuring the integrity of the data throughout the migration, and addressing any technical issues.
Quality Assurance Personnel: Responsible for conducting validation and verification of the data migration process to ensure compliance with regulatory standards.

Procedure

Identification of Data to be Migrated: Collaborate with data owners to identify electronic data that needs to be migrated. Categorize data based on criticality and relevance.
Data Migration Plan: Develop a comprehensive data migration plan outlining the objectives, scope, timelines, resources, and responsibilities. Include risk assessments and mitigation strategies.
Data Mapping: Create a mapping document that clearly defines the relationship between data in the source system and the corresponding data in the target system. Include metadata and any transformation rules.
Backup of Source Data: Before initiating the migration, perform a complete backup of the source data to ensure data integrity and provide a restore point in case of any issues during migration.
Execution of Data Migration: Execute the data migration plan according to the defined timelines. Monitor the migration process, address any issues promptly, and ensure data accuracy during the transfer.
Validation of Data Migration: Conduct validation and verification activities to ensure that the migrated data in the target system accurately reflects the source data. Verify data integrity, completeness, and consistency.
Documentation of Data Migration Activities: Maintain detailed records of all data migration activities, including the migration plan, mapping document, backup records, execution logs, and validation results.
Communication: Communicate the completion of the data migration process to relevant stakeholders. Provide information on the location and accessibility of the migrated data in the target system.
Periodic Review: Periodically review the migrated data to ensure its continued accuracy and relevance in the target system. Address any discrepancies or issues as needed.
Training: Provide training to personnel involved in the data migration process to ensure a thorough understanding of the procedures and the importance of data integrity.

Abbreviations

No abbreviations are used in this SOP.

Documents

Data Migration Plan
Data Mapping Document
Data Migration Execution Log
Validation and Verification Records

Reference

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

SOP Version

Version 1.0