PV Quality & Compliance

Overview

An effective pharmacovigilance system requires more than case processing and regulatory reporting. It also depends on documented procedures, quality oversight, training, reconciliation, deviation management, CAPA, vendor control, compliance monitoring, and periodic review.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports Marketing Authorization Holders, pharmaceutical companies, CROs, and other life-sciences organizations with development, review, and improvement of pharmacovigilance quality systems and compliance processes.

Our approach integrates PV operations, quality management, documentation, performance monitoring, agreements, training, system controls, audit readiness, and continuous improvement to help organizations maintain effective pharmacovigilance oversight.

Our PV Quality & Compliance Services

PV Quality System Development

Support for establishing or strengthening the quality framework governing pharmacovigilance activities.

PV Compliance Gap Assessment

Structured review of current PV processes, documentation, systems, responsibilities, and controls to identify compliance gaps and improvement opportunities.

Case Quality Review

Independent review of processed cases for completeness, accuracy, coding consistency, medical logic, documentation quality, and reporting requirements.

Deviation Management

Support for identification, documentation, investigation, assessment, and closure of pharmacovigilance deviations.

CAPA Management

Support for root-cause analysis, corrective and preventive action planning, implementation tracking, and effectiveness checks.

Change Control

Support for controlled assessment and implementation of changes affecting PV processes, systems, SOPs, products, responsibilities, agreements, or regulatory activities.

Reconciliation

Support for reconciliation of safety information between:

• Internal departments
• Business partners
• Distributors
• Medical information
• Product complaints
• Literature sources
• Regulatory reporting records
• Safety databases
• Other relevant safety-data sources

Compliance Monitoring

Development and review of compliance metrics, timelines, quality indicators, overdue activities, and performance trends.

Vendor & Partner Oversight

Support for qualification, monitoring, performance review, and oversight of outsourced PV activities and safety-data exchange partners.

Documentation Control

Support for controlled management of SOPs, forms, templates, trackers, agreements, training records, and other PV quality documentation.

PV Audit & Inspection Readiness

Assessment and preparation support for pharmacovigilance audits and regulatory inspections.

Key PV Quality Areas

Depending on scope, MGS may support:

• ICSR quality
• Reporting compliance
• Literature compliance
• Signal-management compliance
• Aggregate-report timelines
• SDEA/PVA compliance
• Reconciliation
• PSMF maintenance
• SOP compliance
• Training compliance
• Database controls
• User access
• Data integrity
• Deviations
• CAPA
• Change control
• Vendor oversight
• Documentation
• Record retention
• Archival
• Business continuity
• Quality metrics
• Management oversight

PV Compliance Metrics

MGS can support development or review of metrics such as:

• Case-processing timeliness
• Regulatory-reporting timeliness
• Follow-up completion
• Quality-review findings
• Medical-review status
• Literature-search compliance
• Reconciliation completion
• Aggregate-report status
• Signal-assessment status
• Training compliance
• SOP review status
• Deviation aging
• CAPA aging
• Agreement review status
• PSMF update status
• Database change status

Our Approach

• Assess

Review the existing PV system, processes, procedures, systems, agreements, records, and quality controls.

• Identify Gaps

Document operational, procedural, documentation, system, and oversight weaknesses.

• Prioritize

Classify issues based on potential impact on patient safety, regulatory compliance, data quality, and PV-system effectiveness.

• Remediate

Support development and implementation of CAPA, procedure updates, training, system improvements, and process controls.

• Monitor

Establish quality metrics, compliance trackers, reconciliation, periodic review, and management oversight.

• Maintain & Improve

Support continued compliance, trend review, effectiveness checks, audit readiness, and ongoing quality improvement.

Typical Deliverables

Depending on scope, MGS can provide:

• PV quality-system framework
• PV compliance assessment
• Gap-analysis report
• Case quality-review records
• Deviation documentation
• Root-cause analysis
• CAPA plans
• Change-control assessments
• Reconciliation records
• Compliance metrics
• Quality dashboards
• Vendor oversight records
• SOP review support
• Training-compliance tracker
• Audit-readiness checklist
• Inspection-readiness support
• Remediation tracker
• Periodic quality-review reports

Why Choose MGS

PV & Quality Integration

MGS combines operational pharmacovigilance knowledge with quality-system and compliance expertise.

Risk-Based Oversight

Quality effort is focused on activities with the greatest potential impact on patient safety, regulatory obligations, and data reliability.

Practical Remediation

Our approach focuses on identifying the underlying issue and implementing sustainable corrective actions rather than only closing observations.

End-to-End PV Perspective

Quality controls can be integrated across case management, literature, signals, aggregate reporting, agreements, PSMF, databases, and training.

Inspection-Ready Focus

MGS helps organizations maintain clear documentation, traceable decisions, defined responsibilities, and supporting evidence for audits and inspections.

Who We Support

MGS can provide PV Quality & Compliance support for:

• Marketing Authorization Holders
• Pharmaceutical companies
• Biopharmaceutical organizations
• CROs
• Generic-drug companies
• Product-license partners
• Organizations outsourcing PV activities
• Companies establishing new PV quality systems
• Organizations undergoing remediation
• Companies preparing for PV audits or inspections