PV QMS

Quality Management System (QMS)

Quality Management System (QMS)

Pharmacovigilance Quality Management System (PV QMS)

Build a Robust, Compliant, and Inspection-Ready Quality System

Within a regulatory environment governed by Good Pharmacovigilance Practices (GVP), Marketing Authorization Holders (MAHs), pharmaceutical companies, and Life Sciences organizations must maintain a Quality Management System (QMS) ensuring effective oversight of pharmacovigilance activities.

A robust PV Quality Management System is essential to:

– ensure regulatory compliance

– guarantee reliability of safety data

– secure outsourced activities

– control operational risks

– prepare effectively for ANSM and EMA inspections

Health authorities pay particular attention to the robustness of pharmacovigilance quality systems during audits and inspections.

Atessia Vigilances supports pharmaceutical companies, biotech firms, and MAHs in the implementation, optimization, and reinforcement of PV Quality Management Systems across France and Europe.

Our objective: to build sustainable, compliant, and operational quality systems aligned with your regulatory and organizational challenges.

Build an Organization Aligned with GVP Requirements

An effective pharmacovigilance quality system relies on clear governance, defined responsibilities, and documented processes.

Atessia Vigilances supports organizations with:

  • design of PV Quality Systems
  • definition of roles and responsibilities
  • structuring of quality governance
  • formalization of critical processes
  • integration of EMA and ANSM requirements


A structured organization designed to ensure consistency, traceability, and regulatory compliance.
Secure Your Processes and Pharmacovigilance Activities

Quality documentation is a central pillar of the pharmacovigilance system and a key focus area during inspections.

Our teams support:

  • drafting and updating SOPs
  • work instructions and operational procedures
  • quality documentation related to PV activities
  • validation and approval workflows
  • harmonization of local and global documentation


Robust, pragmatic, and compliant documentation aligned with health authority expectations.
Strengthen Oversight of Quality Risks

Management of deviations and corrective actions is essential to ensure continuous improvement of the PV system.

Atessia Vigilances supports:

  • identification and management of deviations
  • root cause analysis
  • implementation of CAPAs
  • change control processes
  • monitoring of corrective and preventive actions


A risk-based quality approach designed to sustainably strengthen regulatory compliance.
Strengthen Your Quality Governance

Outsourced pharmacovigilance activities require rigorous oversight to ensure operational compliance and proper management of regulatory responsibilities.

Our experts support:

  • quality oversight of PV vendors
  • assessment of partners and distributors
  • review of Pharmacovigilance Agreements (PVAs)
  • quality follow-up of outsourced activities
  • implementation of oversight controls


Quality governance designed to reduce risks associated with outsourcing models.
Effectively Manage Your PV Quality System

Monitoring of quality indicators is essential to measure performance and identify improvement opportunities.

Atessia Vigilances implements:

  • KPIs adapted to PV activities
  • quality monitoring tools
  • periodic review plans
  • trend analyses
  • continuous improvement initiatives


Clear visibility of quality performance designed to strengthen oversight of safety activities.
The pharmacovigilance quality system is a critical component of regulatory inspections.

Atessia Vigilances supports organizations through dedicated inspection readiness programs, including:

  • PV Quality System reviews
  • GVP gap assessments
  • mock inspections
  • documentation preparation
  • review of critical processes
  • team support during inspections


A proactive preparation model designed to reduce regulatory risk and strengthen compliance levels.
Systems Designed to Be Operational and Auditable

Our interventions are based on:

  • Good Pharmacovigilance Practices (GVP)
  • EMA and ANSM requirements
  • quality standards applicable to PV systems
  • a pragmatic and operational field-oriented approach


We ensure:

  • robust and auditable processes
  • compliant documentation
  • operational recommendations
  • systems tailored to your organization


A balanced approach combining regulatory compliance, operational efficiency, and continuous improvement.

Why Choose Atessia Vigilances ?

Experienced consultants specialized in PV Quality Management Systems and regulatory compliance.

Compliance with EMA, ANSM, and GVP expectations.

Quality systems designed to support audits and regulatory inspections.

Solutions tailored to your organization and PV maturity level.

Targeted support or full structuring of PV Quality Systems according to your needs.

What You Gain by Working with Us

– Strengthened regulatory compliance
– Improved control of quality and operational risks
– Secured pharmacovigilance activities
– Enhanced preparedness for EMA and ANSM inspections
– Continuous improvement of your PV Quality System

Atessia Vigilances supports pharmaceutical companies, biotech firms, and MAHs in the structuring, optimization, and security of pharmacovigilance quality systems across France and Europe.

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