PSMF setup & maintenance ensures regulatory compliance by establishing & managing Pharmacovigilance System Master Files with meticulous attention to detail. At Atvigilx, our dedicated team handles the setup & ongoing maintenance of PSMFs, ensuring alignment with regulatory requirements. We conduct thorough reviews, updates, & audits to ensure accuracy & completeness. Additionally, we provide comprehensive support, including staff training & SOP development, to enhance system effectiveness.
PSMF Compilation and Maintenance Support
Comprehensive support for compiling and maintaining the Pharmacovigilance System Master File (PSMF), ensuring compliance and up-to-date documentation.
Continuous oversight and upkeep ensure an audit/inspection-ready PSMF, providing the QPPV and authorities with current, accurate information.
Access to the PSMF
Immediate access to the PSMF is available upon request by competent authorities, either at the specified PSMF location or the QPPV site, ensuring compliance.
Change Control Process
Actively solicit all changes, including organizational, contractual, mergers, & transfers, from the MAH to ensure robust change control for the PSMF information.
