Guidelines for Managing Pharmacovigilance Databases

1) Purpose

The purpose of this SOP is to define the procedures for managing pharmacovigilance databases to ensure data integrity, security, and accessibility for safety monitoring and reporting.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the management of safety databases, including database administrators, data entry operators, and safety specialists.

3) Responsibilities

The Database Management Team is responsible for maintaining the pharmacovigilance database. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Database Setup

1. Configure the database according to the organization’s requirements and regulatory guidelines.
2. Ensure proper access controls are in place to restrict unauthorized access.
3. Implement data encryption to protect sensitive information.

4.2 Data Entry and Maintenance

1. Enter data accurately and completely into the database using standardized forms.
2. Regularly update the database with new information and corrections.
3. Perform routine maintenance to ensure optimal database performance.

4.3 Data Backup and Recovery

1. Establish a regular schedule for database backups to prevent data loss.
2. Store backup copies in a secure, offsite location.
3. Test data recovery procedures periodically to ensure they work effectively.

4.4 Data Security

1. Implement robust security measures to protect the database from unauthorized access and cyber threats.
2. Regularly update security protocols and software to address emerging threats.
3. Monitor database access logs