To meet the growing global PV requirements for country/region specific PSMFs, the expansion of existing tools and adaptation of the Roche EU PSMF process was required to enable a compliant, consistent, efficient and cost effective PSMF creation and maintenance process.
Processes enabling the sharing of global information contained in the EU PSMF Core/Annexes were developed and the existing processes for automated PSMF Annex generation, via the Roche in-house IT Tool “PSMF Generator”, were expanded to produce country/region specific Annexes.  
We have created a single, scalable and efficient process for the production of quality PSMFs within Roche.  The IT tools devised enable replacement of manual data collection/production by automatic data collection/production, reducing workload and enabling a focus on quality and analysis, and ensure Roche can adapt quickly to new local regulations.  Affiliates in regions/countries with legislation requiring a local PSMF/PSSF are able to produce local PSMF/PSSFs autonomously, utilising standardised templates and accessing consistent, up to date global information as required.  It is approximated that there has been a saving of approximately 6.5 FTE within global and affiliate teams following the launch of the updated systems and processes.  Moreover, the risk of non-compliance with global legislation requiring a PSMF/PSSF is greatly reduced.
The documents produced in this way enable oversight of the global and local PV system by Local QPPVs/PV Responsibles, provide reassurance of the foundation of a quality PV system and allow swift resolution of non-compliance.

Roche Pharmaceuticals - Globalisation of the PSMF Process