Standard Operating Procedure for Data Security and Access Control

Purpose

The purpose of this SOP is to establish procedures for ensuring the security of electronic data and controlling access to sensitive information 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 management of electronic data, including operators, IT personnel, and quality assurance personnel.

Responsibilities

• Data Owners: Responsible for classifying data based on sensitivity, defining access levels, and periodically reviewing and updating access permissions.
• IT Personnel: Responsible for implementing and maintaining data security measures, access controls, and monitoring systems to safeguard electronic data.
• Quality Assurance Personnel: Responsible for conducting periodic reviews and audits to ensure compliance with data security and access control procedures.

Procedure

1. Data Classification: Collaborate with data owners to classify electronic data based on its sensitivity and criticality. Establish categories such as public, internal use, confidential, and restricted access.
2. Access Control Levels: Define access control levels for each category of data. Clearly specify the permissions associated with each level, including read, write, modify, and delete capabilities.
3. User Authentication: Implement robust user authentication mechanisms, such as secure usernames and passwords, biometric authentication, or multi-factor authentication, to ensure that only authorized personnel can access sensitive data.
4. Access Requests: Establish procedures for submitting access requests. Clearly define the information required in an access request, including the type and reason for data access.
5. Authorization of Access Requests: Verify the authenticity and authorization of access requests before granting access to sensitive data. Maintain logs of access requests and approvals.
6. Regular Access Reviews: Conduct regular reviews of user access permissions to ensure they align with current roles and responsibilities. Update access permissions promptly when personnel changes occur.
7. Access Logging: Implement access logging mechanisms to record details of data access, including the user, date, time, and type of access. Regularly review access logs for any unauthorized activities.
8. Security Training: Provide training to personnel on data security best practices, including the importance of safeguarding access credentials, recognizing security threats, and reporting suspicious activities.
9. Periodic Security Audits: Conduct periodic security audits to assess the effectiveness of access controls, data encryption, and other security measures. Address any identified vulnerabilities promptly.
10. Incident Response: Define procedures for responding to security incidents, including unauthorized access or data breaches. Implement corrective actions and preventative measures based on incident investigations.
11. Documentation of Security Measures: Maintain detailed records of all security measures, including access control policies, access logs, security training records, and incident response documentation.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Data Classification Matrix
• Access Request Form
• Access Log
• Security Training Records

Reference

ISO/IEC 27001 – Information security management systems

SOP Version

Version 1.0