PSMF Module


About the module

  • Manage multiple PSMF (pharmacovigilance system master file) versions with separate contributors. Workflow for each annex - Built around a powerful workflow engine that will allow for the review, approval and management of any data point in the PSMF

  • Configurable to local guidelines - and maintain multiple different versions of the Annexes, e.g. for EEA, France, CIS, India in the same application

  • Removes the need for emailing of documents for review to affiliates and other stakeholders

  • Allows ease of document generation – as no manual data collation is required, focus of review is on content

  • Auto-generate annexes, format using Word templates. Template based document creation but also with “text snippets” that allow controlled introduction of non-core template text

  • Management and selection of PSMF data from multiple sources and systems gives you complete and accurate information – Links to multiple modules: Entities and Agreements, Products, Clinical Studies, Data Collection Programs, Submissions, QMS

  • Automates data gathering of Annexes

  • Auto-generate Annex I (logbook)

  • Maintains an audit trail for all changes and updates

  • Use various pdf functionalities for headers/footers and merging of final document

  • Is GxP validated* and ready to use in the cloud

*Validation package provided with documented proof of execution of test cases according to Insife’s standard process configuration. Additional validation activities may be needed to satisfy needs for your organization.

Further details

HALOPV PSMF module is an easier and more flexible way to produce the PSMF. Makes it possible to automate generation of main documents and annexes. It is part of the set of Oversight and Quality modules

Want to know more, get a demo or take it for a test drive?

We are ready to provide your with further information, and can setup a demo for you, where we take you through a guided tour of the application. If you would like to take it a step further, we also have test environments for you to explore in detail. 

Write to - we are looking forward to helping your organization!