Pharmacovigilance System Master File (PSMF / PVMF)
PSMF / PvMF – It’s a Document Represents Overall Structure of Pharmacovigilance System
Pharmacovigilance System Master File (PSMF / PVMF) describes the pharmacovigilance system and support/document its compliance with the requirements. The PSMF / PVMF provides an overview of the pharmacovigilance system including structure of company, high level description of different pharmacovigilance process, computerised systems and databases, pharmacovigilance system performance and quality management system followed by Annexes.
PSMF / PVMF Annex are very important matrix because as it provide significant information entire Pharmacovigilance system as listed below.
- QPPV/LRPV
- Company organogram
- List of agreements
- Sources of safety data
- Computerised system and Databases
- Procedures details
- PV system performance Indicators
- Audit details and Product list
Our Solution for Complete PSMF / PvMF Activity
AllyWorth supports for your PSMF / PVMF and Summary of Pharmacovigilance System (sPhVS) preparation and routine update to ensure with the followings updates.
- To maintain the PSMF / PVMF in-line with existing / updated procedures
- To update the PSMF / PVMF Annex with latest updates
- To keep the PSMF / PVMF ready for authority inspection ready at any-time.