Why One-Click Generation Matters
Creating submission-ready PSMF documents is now effortless. With organization's PV information continuously updated in PSMF Manager and aligned with EMA GVP Module II and applicable local guidelines (structure, content, etc.), the exported PSMFs remain fully compliant at all times.
This makes generation more than a formatting step. It becomes a controlled release process tied to the latest approved content.
From Updates to Final Output
Once updates are completed across relevant Sections and Annexes, the PSMF Coordinator can create a read-only version of the PSMF document with a single click using the Generate PSMF Document feature. After reauthentication, the system instantly compiles the latest PSMF data into a professionally formatted PDF, complete with bookmarks for all updated Sections and Annexes and an auto-generated change log (Annex I).
Built for Review and Approval
A real-time progress indicator keeps users informed throughout the generation process, and a confirmation pop-up signals successful document generation. The final PDF version of the PSMF can be reviewed, saved, and shared for approval signatures as required.
What Teams Gain
With PSMF Manager, generate submission-ready PSMFs at the click of a button—powered by standardized templates and built-in compliance checks. Save significant time and effort with automated, submission-ready PSMFs that are instantly accurate and compliant whenever stakeholders need them.