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USER ACCESS MANAGEMENT

USER ACCESS MANAGEMENT FOR GMP ENVIRONMENTS

Control and automate physical and logical access management in a secure, traceable, and GxP-compliant manner.

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What is User Access Management
of PRAGMA4U®?

The digital solution to address one of the most critical needs in regulated environments: to manage access to systems and physical environments in a centralized, traceable, and compliant manner. All this with rapid implementation times, easy integration, and adaptable configurations without the need for code development.

In GxP environments, uncontrolled or manually managed access is one of the leading causes of noncompliance, operational risk, and inefficiency. This module transforms access management from an administrative burden into a strategic function, natively integrated into business processes.

GIF Gestione Accessi

What does it allow you to do?

Access Control

Manage the entire lifecycle of physical and logical access

Define permissions based on roles, departments, locations, and responsibilities

Joinre the users to IT devices with traceand traceability

Automation and Integration

Automate onboarding and offboarding

Integrate with Active Directory or operate in standalone mode

Link access rights and training to ensure consistent assignments

Compliance and Audits

Manage digital approvals with electronic signatures that comply with FDA 21 CFR Part 11

Planre periodic of accesses according to SOP

View the complete, unalterable audit trail

Monitoring

View users, permissions, and anomalies from a centralized dashboard

Integrate access management with other PRAGMA4U modules

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What are the benefits compared to paper-based and/or hybrid systems?

Access Management:
Paper-Based and/or Hybrid

Access managed using manual and unsynchronized tools (e.g., Excel + paper form)
Slow and difficult-to-track approval workflows
Little or no oversight of active accounts
Manually Managed Onboarding and Offboarding
Difficulty in Responding to Inspections
Ineffective coordination between departments
Permissions Granted Without Role-Based Logic

Digital Management with
User Access Management

Centralized, digitized, and monitored access
Approval workflows with electronic signatures and automatic audit trails
Automated Periodic Access Reviews
Automated and integrated management of onboarding and offboarding
Everything tracked, everything accounted for: reports ready for every audit
A single, integrated platform: less operational burden, more collaboration
Faster assignment and revocation of access rights, consistent with roles and responsibilities

With PRAGMA4U® Go Beyond Access Management

PRAGMA4U® is an all-in-one platform for the digital transformation of business processes, compliant with cGMP, FDA, and Eudralex.

Access management is just one of the modules you can implement and expand over time, with the ongoing support of a team of experts.

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PRAGMA4U - GIF GENERICA

Fewer risks, more control, stress-free audits

Centralize access management, reduce your operational workload, and ensure full regulatory compliance.

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Achieve your goals with timely and accurate data.