The pharmacovigilance audit universe is not limited to the distributors, business partners, affiliates,and vendors / service providers. One also needs to consider pharmacovigilance processes as well as processes of cross-functional departments which may have a direct or indirect impact on patient safety compliance.

These processes are not limited to:

1. PSMF Management
2. QPPV
3. Request for information (RFI) – also called as queries raised by health authorities
4. Risk Management
5. Safety Data Exchange Agreements
6. Aggregate Safety Reporting
7. Signal Management
8. Regulatory – Safety Variations, Labeling Compliance (mainly safety) and Artwork Management
9. Information Technology
10. Quality and Computer Software Assurance (erstwhile CSV)
11. Patient Support and Market Research Programs

Information Technology

Of the above-listed process information technology may seem like an ambiguous one. The information technology-related audits would encompass the safety database, medical information, used for the company website(s), product-specific website(s), infrastructure, BCP as well as disaster recovery and management. In short, the scope will be beyond the systems enlisted in the Annex C of the PSMF.

How frequently should you audit?

While a frequency of 2-5 years for audit scheduling is acceptable, it is recommended to undertake the process audits more frequently (every 2-3 years) irrespective of risk assessment analysis. Most importantly, this is over and above the routine self-inspections for the pharmacovigilance processes.