Guidelines for Pharmacovigilance Data Retention and Destruction

1) Purpose

The purpose of this SOP is to establish procedures for the retention and secure destruction of pharmacovigilance data in compliance with regulatory requirements and company policies.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the collection, storage, retention, and destruction of pharmacovigilance data.

3) Responsibilities

The Data Management Officer is responsible for ensuring that data retention and destruction procedures are followed. The Pharmacovigilance (PV) Manager oversees compliance with this SOP and ensures all relevant personnel are trained accordingly.

4) Procedure

4.1 Data Retention

1. Identify and categorize the types of pharmacovigilance data that need to be retained.
2. Develop a data retention schedule that specifies the retention periods for each type of data based on regulatory requirements and company policies.
3. Ensure that all data is stored securely and is accessible only to authorized personnel during the retention period.
4. Conduct regular reviews of stored data to ensure compliance with the retention schedule.

4.2 Data Destruction

1. Identify data that has reached the end of its retention period and is no longer required for legal, regulatory, or business purposes.
2. Securely destroy data using appropriate methods such as shredding, degaussing, or secure digital deletion to ensure that it cannot be recovered or reconstructed.
3. Document the destruction process, including the date of destruction, the method used, and the personnel involved.
4. Ensure that data destruction is performed in accordance with applicable laws and company policies.

4.3 Data Archiving

1. For data that needs to be retained beyond the standard retention period for historical, legal, or research purposes, ensure it is securely archived.
2. Store archived data in a secure, accessible, and organized manner.
3. Maintain an inventory of archived data and regularly review it to determine if it can be destroyed or should be retained further.

4.4 Training and Awareness

1. Provide regular training to all PV personnel on data retention and destruction procedures and best practices.
2. Ensure that new employees receive training on data retention and destruction as part of their onboarding process.
3. Conduct periodic refresher training to reinforce the importance of compliance with data retention and destruction policies.

4.5 Monitoring and Auditing

1. Regularly monitor data retention and destruction practices to ensure compliance with this SOP and regulatory requirements.
2. Conduct periodic audits of data storage, retention, and destruction activities.
3. Document and address any findings from monitoring and auditing activities promptly.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Data retention schedules, data destruction logs, training materials, audit reports.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Good Pharmacovigilance Practices, EU Guidelines on Good Pharmacovigilance Practices (GVP) Module I – Pharmacovigilance Systems and Their Quality Systems.

8) SOP Version

Version 1.0