Gruppo SASI offer service "PSMF-Manager"

Gruppo SASI's PSMF Manager handles the Pharmacovigilance System Master File in line with current EU requirements under Directive 2010/84/EU amending Directive 2001/83/EC, and meets CFR 21 Part 11 and Annex 11 standards. Features include automated document creation in Word format with template association, lifecycle management for PSMF changes, version control that logs every edit, audit trails of key user actions, user profiling for access control, and automatic generation of the final PSMF in PDF.