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