Automate your global and local PSMF
business processes minimizing
manual steps and outsourcing costs

Pharmacovigilance System Master File (PSMF)

The PSMF is a legally required document in the EEA describing the pharmacovigilance system of a marketing authorization holder. It is a modular document consisting of a main body and annexes. The global (EU) PSMF consists of a main body and several Annexes. The global PSMF is also the basis to create the local PSMF for each specific country. The number and content of the Annexes can differ across the global and local documents. The process of maintenance and update of the PSMF main body and annexes is utilizing a combination of tools and manual processes. Gap in business process and tools lead to incorrect outputs and errors incurring additional cost and re-work. The lack of alignment between the main body, annexes, global and local PSMFs introduces inconsistency, duplication and can lead to compliance issues.

Quartica’s solution provides an end to end automated approach to  the planning, update triggering, document creation, review, approval and compilation of both the global and local PSMFs. This includes quarterly updates to the main body and annexes including any ad-hoc updates required. The Quartica solution integrates content from the various formats (Word, PDF, Excel) to automatically update the relevant content in the main body and annexes of the PSMF document. Quartica also automates the flow of content from the Global PSMF to the Local PSMF sections ensuring consistency and flow of information between the global and local documents. MARS also supports flow of information from other business process areas such as PVA to automatically generate input to be included in the relevant PSMF Annexes. It also provides the capability to plan, schedule, notify and update Logbook while bringing the content attributes for use and reuse an adherence to compliance and reporting.

Key Features

Manage end-to-end global and local PSMF process including planning,, document generation, review and assembly
Automate Logbook updates based on changes to main body and annexes
Collaborate document updates by in parallel within the same document and saving time
Auto update document content based on input updates
Manage Review and Approval workflow process
Track decision log, review and approval history for complete traceability
Automate creation of annexes using specific templates and raw data
Reminders and Notifications to ensure all updates are completed
Automate local PSMF from the global PSMF based on workflow mapping.

Benefits

Reduction in manual steps, guess work and outsourcing cost

Improved compliance and standardization of content

Automated compliance reports and metrics

Consistency in information across various safety functional areas

Automation tailored for the specific regulatory & validation needs of the life sciences industry

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