Features of PSMF Manager

Ensure PSMF is always audit-ready with our enhanced Features

From version control to AI-powered compliance monitoring, built-in features safeguard efficient PSMF management with decreased manual efforts, aligned PSMF lifecycle and improved traceability

Discover competencies of PSMF Manager

A structured overview of the core features that support compliant, accurate and inspection-ready PSMFs

Country PSMFs
Seamless Local PSMF Management with Global PSMF

Seamless Global & Local PSMF Management

Managing affiliate PSMFs in a central platform with effortless data mapping avoids redundancies and duplication across PSMFs, enabling sync with global PSMF in real time

Audit Trails
Full Version History and GxP Audit Trails

Full Version History and GxP Audit Trails

Every edit is time-stamped and securely logged, preserving each PSMF version for accountability, traceability and seamless access, especially during audits and inspections.

Track Changes
Accelerate Reviews of Every Change

Accelerate Reviews of Every Change

Highlighting revisions instantly simplifies the review process with clear tracking of changes and reduced manual efforts, helping making further edits quicker and more accurate.

External Integrations
Integration With External Data Sources

Integration With External Data Sources

Reduce manual data entry minimizing human errors in PSMF information by syncing updated data directly from leading databases and enterprise systems into one unified platform.

One-Click PSMF
Publish PSMF Documents at the Click of a Button

Publish PSMF Documents at the Click of a Button

PSMF Documents are generated instantly and formatted consistently, saving resources time and effort with auto-created PDFs consistently aligned with standard regulatory templates.

Ask AI
AI simplifies Change Reviews and Annex I maintenance

AI accelerates Reviews and maintains Change Logs.

Review and assess changes for factual accuracy, internal alignment and consistency with regulations and auto-entered details within Change Logs through AI capabilities.

Explore More Features

PSMF Manager's built-in features make maintaining and updating the PSMFs significantly quicker, more efficient, and considerably less resource-intensive

Pre-set Template (per EMA GVP Module II & Local Regulations)

System-generated automated alerts and reminders

Role based Access Control with Streamlined Workflows

Compare Changes across PSMF versions and data/files

Centralized Storage of all organizational PSMFs versions

In-built Search, Chat Support feature and Technical Manual access

Master Table Repository for all Sources of Information

System Lock and Unlock Features for PSMF revision

Excited to see if these capabilities fit your compliance workflow?

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