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Get Started with PSMF Manager Today!

PSMF Manager is a web-based, fully automated compliance solution that helps pharmacovigilance teams maintain perfect audit readiness through:

  • Feature: Automated PSMF document generation
  • Real-time version control
  • Collaborative workflows
  • Secure cloud storage
  • Regulatory change tracking
  • Compliance monitoring

Powerful Features
to Simplify Your Workflow.

  • Version Control

    Easily manage and trace different versions of PSMF documents.

    Keep track of changes with automated version updates and easy access to view previous document versions.

  • Audit Trails

    Comprehensive logs for all document interactions.

    Maintain logs of all actions within the system for complete transparency and accountability, ensuring compliance with the latest standards.

  • Real-Time Alerts

    Stay up to date with email notifications for all important updates.

    Set up notifications for upcoming document reviews, comments, and important revisions.

  • Role-Based Access Control

    Ensure secure access by limiting permissions based on roles.

    Assign specific tasks to users, from PSMF Coordinator to Contributors, safeguarding access.

  • Master Table

    View all information and associated files distinctly in dashboards.

    Retain a centralized view of all source data and all associated information, making data management simpler and more efficient, with correlated records.

  • Track Changes

    Track edits effortlessly throughout the document.

    Highlight all text edits across the PSMF in red (deletion) or green (addition) for easy viewing, with change tracking and change logging.

  • Change Approval Workflow

    Document the approval process and activities seamlessly.

    Approvers reject or approve each of the requested changes, with suggested remarks and comments, and its history being retained in the system.

  • Change Logs

    Maintain flawless audit trails on an ongoing basis.

    Track each change made to the document with date & timestamps, reason for edits and a correlated entry automatically into the change log for PSMF Annex I.

  • Integrate current version of PSMF into the PSMF Manager tool.Feature 1

  • Develop and maintain PSMF draft versions digitally while collaborating across various teams.Feature 2

  • Automatically generate the digital PSMF document, reducing time and errors.Feature 3

  • Assisted with Technical Manual and Helpdesk, involving around the clock email and chat support with auto-ticketing.Feature 4

Complete Accountability while maintaining security.

Enterprise-Grade Security
You Can Trust.

Prioritizing security with cutting-edge protocols to ensure your data is always protected, with extra layers of security to safeguard sensitive information.

  • Authentication

    Secure two-factor authentication, password management, and requirement of QC check for enhanced accuracy

  • Encryption

    SSL/TTLS protocols ensure secure data transmission and storage

  • Backup

    Continuous backup of documents and data automatically on AWS Cloud to prevent data loss

  • Controls

    Limit user access based on their role within the organization

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CertificationsArrow Right

PSMF Manager -A Fully Validated and Compliant SaaS Solution.

PSMF Manager is a Web-based SaaS Model which is fully validated and compliant with EMA GVP Module II, US FDA 21 CFR Part 11, EU GMP Annex 11 & GAMP5 Certifications, with advanced capabilities to keep you ahead.