Build a Documentation System Compliant with GVP Requirements


Preparation of a PSMF requires in-depth expertise in:

• European regulatory requirements
• pharmacovigilance organization structures
• local and global activities
• quality and safety processes

Atessia Vigilances supports clients with:

• creation of global or local PSMFs
• structuring of content in accordance with GVP Module II
• mapping of pharmacovigilance activities
• identification of roles and interfaces
• formalization of critical processes
• alignment between governance, quality, and operational PV activities

A structured PSMF designed to accurately reflect your organization and demonstrate control of your PV system.

Ensure Your Documentation Remains Accurate and Compliant


The PSMF must continuously reflect the operational and organizational reality of the pharmacovigilance system.


Our teams support:

• ongoing PSMF maintenance
• periodic updates
• management of organizational changes
• integration of regulatory developments
• documentation consistency reviews
• oversight of outsourced activities and business partners

A dynamic documentation governance model designed to sustainably maintain regulatory compliance.

Strengthen the Consistency of Your PV Documentation System


PSMF annexes represent critical elements during regulatory inspections.


Atessia Vigilances supports:

• structuring of regulatory annexes
• updates of product and partner listings
• management of contracts and Pharmacovigilance Agreements (PVAs)
• oversight of organizational charts and responsibilities
• review of PV systems and tools
• documentation traceability of safety activities

Consistent, reliable documentation aligned with EMA and ANSM expectations.

Address Both Local and European Requirements


MAHs and multi-country organizations must ensure consistency between global governance models and local regulatory obligations.


Our experts support:

• creation of Local PSMFs
• adaptation of documentation to French regulatory requirements
• integration of French Local PV Responsible Person (LPPV/RPV) responsibilities
• alignment between global and local organizational structures
• consistency between documentation and MAH operational activities

An integrated approach designed to secure both local and European regulatory obligations.

Strengthen Oversight of Your Processes and Responsibilities


The PSMF is part of a broader documentation governance framework covering the entire pharmacovigilance quality system.


Atessia Vigilances supports organizations with:

• PV documentation structuring
• SOP and workflow management
• version control and approval processes
• change traceability
• consistency between procedures, contracts, and operational activities
• integration of quality and inspection readiness requirements

Documentation governance designed to strengthen the robustness and traceability of your PV system.

Prepare Effectively for EMA and ANSM Inspections


The PSMF and PV quality documentation are systematically reviewed during regulatory inspections.


Atessia Vigilances supports healthcare organizations with:

• PSMF compliance reviews
• GVP gap assessments
• inspection-ready documentation reviews
• preparation of critical annexes
• consistency reviews of outsourced activity documentation
• inspection preparation of operational teams

A proactive approach designed to reduce regulatory risk and strengthen compliance levels.

Documentation Systems Designed to Be Auditable


Health authorities expect documentation systems to be:

• consistent
• traceable
• up to date
• aligned with actual operational practices
• easily accessible during inspections

Our teams ensure:

• robust methodologies
• documentation quality controls
• adapted validation processes
• pragmatic documentation organization
• alignment with EMA, ANSM, and GVP requirements

Documentation systems designed to effectively support inspections and regulatory audits.

Solutions Tailored to Your Organization


Each organization has:

• its own organizational model
• a different PV maturity level
• specific tools and documentation processes
• local and global constraints

Atessia Vigilances provides tailored support models including:

• targeted support
• documentation maintenance
• PSMF remediation
• quality structuring projects
• strategic governance support

Flexible expertise designed to integrate sustainably into your organization.