AI Powered PSMF Management

AI-Powered
PSMF Management

Streamline PSMF lifecycle with PSMF Manager .End-to-end PSMF workflows help organizations from inspection readiness to compliance monitoring

AI-Driven Pharmacovigilance

Powerful AI features work together to simplify various options and automate PSMF documentation workflows

AI Review Assistant

Simplifying complex case reviews, ensuring transparency and enhancing reliability across PSMF modifications providing key remarks for updated content.

AI review assistant

Auto-Annex I Generator

Change Logs automatically generated for every case update hassle-free, eliminating the need for manual and retrospective documentation.

AI change log generator
Features

Built for PV Teams, for Inspection-readiness

Core capabilities that transform how pharmacovigilance teams manage, review, and stay inspection-ready faster and with full traceability.

Explore Core Features→
SUBSCRIPTION MODELS

Plans for every User
Across stages of growth

From MAHs to service providers, we offer transparent infrastructure with no hidden tiers.

StandardEnterpriseMulti-Tenant
Standard

All Plan inclusions

All current & upcoming features
Sandbox environment for UAT testing
Onboarding training & Data migration support
In-built Technical Manual
Daily automated backups
Limited Local PSMFs
Enterprise

Dedicated Infrastructure additional inclusions

Private subdomain + Isolated database
Region selection for Data Residency
4-day point-in-time rollback
Priority support: within 1 Business Day

Eager to view the complete breakdown? Compare all tiers, features, and deployment options for the organization.

Ready to see the full breakdown?

Compare all tiers, features, and deployment options.

View All Plans→
Compliance & Security

Built for Regulated Environments for Submission-ready PSMFs

Enterprise-grade protocols and globally recognised validations.
Ensure the PSMF stays compliant at all times

Security

  • Authentication

    Password control, QC check, 2FA and Granular Access Controls to enhance security & accuracy

  • Encryption

    SSL/TTLS protocols ensure secure encrypted transmission and safe storage of all data

Certifications

  • EMA GVP Module II

    Provides comprehensive standards for EU pharmacovigilance documentation and oversight.

  • US FDA 21 CFR Part 11

    Sets stringent regulatory requirements for secure electronic records and digital signatures.

Explore Compliance & Security→
HOW IT WORKS

The PSMF Workflow

Structured, audit-ready lifecycle from Initial Draft unlock through revision to final Approval lock.

Step 01
Initiate

New Document Revision (Unlock Draft PSMF)

Admin/Coordinator initiates a draft PSMF (unlocks new version) that is open for modifications by the Users with role-based access.

Initiate01Edit02Review03Draft04Approve05Lock06PSMFLIFECYCLE

FAQs

Frequently Asked Questions

Is the system compliant with EU and FDA regulations?+
Yes. PSMF Manager is built from the ground up to align with EMA GVP Module II requirements, and features 21 CFR Part 11 compliance for electronic signatures and audit trails.
How long does system implementation take?+
Our dedicated onboarding team works with your QMS framework to migrate your existing data, train your PSMF team and configure any workflows, aiming to be fully operational within 4 to 6 weeks.
Can our external vendors securely input their data?+
Absolutely. You can provision restricted, role-based access for vendors and third-party users. They only see the specific modules or data requests assigned to them, keeping your PSMF information entirely secure.
How do I get started with PSMF Manager?+
Simply reach out to us through the contact details in the footer or submit the request demo form and we will get in touch to set up a demo session, optional free trial for 3 months, or simply get started with PSMF Manager.

Stop reacting to inspections & Start expecting them

Request Demo today if you are Ready to transform your PSMF management

Schedule Your Strategy Call Today