Standard Operating Procedure for Data Anonymization and Pseudonymization

Purpose

The purpose of this SOP is to establish procedures for the anonymization and pseudonymization of sensitive data to protect individual privacy and comply with data protection regulations within the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in the handling, processing, and storage of sensitive data within the pharmaceutical manufacturing facility.

Responsibilities

• Data Protection Officer: Responsible for overseeing the implementation of data anonymization and pseudonymization processes, ensuring compliance with relevant regulations.
• Data Custodians: Responsible for executing data anonymization and pseudonymization procedures for sensitive data under their control.
• IT Security Personnel: Responsible for implementing and maintaining technical measures to support data anonymization and pseudonymization, ensuring the security of the process.

Procedure

1. Data Classification: Classify data based on its sensitivity and the need for anonymization or pseudonymization. Clearly define criteria for determining which data requires protection.
2. Anonymization Techniques: Select appropriate anonymization techniques, such as generalization, suppression, or randomization, based on the type and context of the data. Ensure that the selected techniques provide sufficient protection while preserving data utility.
3. Pseudonymization Techniques: Implement pseudonymization techniques, such as tokenization or encryption, to replace identifiable information with pseudonyms. Store the mapping between pseudonyms and actual identifiers securely.
4. Data Mapping Records: Maintain detailed records of data mapping, including the relationship between original identifiers and pseudonyms. Establish access controls to restrict access to mapping information to authorized personnel only.
5. Data Anonymization Process: Develop and document the step-by-step process for anonymizing sensitive data. Include procedures for verifying the effectiveness of the anonymization process and ensuring that the resulting data is non-identifiable.
6. Data Pseudonymization Process: Develop and document the step-by-step process for pseudonymizing sensitive data. Clearly define the key management procedures for generating, storing, and rotating pseudonyms to enhance security.
7. Testing and Validation: Periodically test and validate the effectiveness of the anonymization and pseudonymization processes. Ensure that the anonymized or pseudonymized data remains suitable for its intended purpose while protecting individual privacy.
8. Documentation: Maintain comprehensive documentation of the data anonymization and pseudonymization processes, including records of executed procedures, test results, and any corrective actions taken. Ensure that documentation is accessible for regulatory inspections.
9. Incident Response: Establish procedures for responding to incidents related to potential data re-identification. Document the steps to be taken in the event of a breach and communicate promptly with relevant stakeholders.
10. Training: Provide training to personnel involved in the data anonymization and pseudonymization processes. Ensure that employees understand the importance of protecting sensitive data and are aware of their roles and responsibilities.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Data Classification Policy
• Anonymization Procedures
• Pseudonymization Procedures
• Data Mapping Records
• Testing and Validation Reports
• Incident Response Plan
• Training Records

Reference

General Data Protection Regulation (GDPR)

SOP Version

Version 1.0