PSMF (Pharmacovigilance System Master File)

THE BEST TOOL OUT THERE FOR MANAGING AND AUTOMATING THE PSMF DOCUMENT AND ANNEXES

Highlights of the PSMF Module

  • Automates data gathering of Annexes

  • Maintains an audit trail for all changes and updates

  • 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

  • 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.

Key features

  • Manage multiple PSMF 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

  • 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

  • Auto-generate Annex I (logbook)

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

BETTER DOCUMENT QUALITY, FASTER UPDATES, SAVE RESOURCES

The Pharmacovigilance System Master File (PSMF) is for many pharmaceutical companies a heavy burden to keep updated. The latest version of HALO PV makes it significantly easier to manage and automate annexes and the main PSMF body, from data collection to formatting, template-based structured content authoring and version control. Effectively handle localized versions. It's comprehensive but simple to use. Get better document quality, faster updates and save resources!