Pharmacovigilance Data Migration Services

Preserving Compliance Integrity While Modernizing Your Safety Data Ecosystem.

As life-sciences organizations evolve, so do their technology platforms. Whether migrating to a new safety database, consolidating systems after a merger, or upgrading to meet evolving regulatory formats, one principle remains constant-data integrity is non-negotiable.

Fidelity Health Services (FHS) delivers end-to-end Pharmacovigilance Data Migration Services engineered to maintain complete accuracy, traceability, and compliance during every stage of system transition. Our proprietary Data Migration and Integration Framework supports small-scale transfers to multi-million-case migrations with precision, transparency, and zero tolerance for data loss.

Why Data Migration Matters

Pharmacovigilance data is a company's regulatory lifeline. Any discrepancy introduced during migration can compromise compliance, distort safety trends, and invite costly inspection findings.

Typical challenges include:

  • Inconsistent source data structures and non-standard coding conventions
  • Variations in ICH E2B(R2/R3) formatting across regions
  • Legacy data gaps and missing audit trails
  • Validation failures due to incomplete verification or documentation

Fidelity mitigates these risks through a structured, risk-based migration approach aligned with GAMP5 and global PV guidelines, ensuring every record is transferred, validated, and reconciled with regulatory precision.

Our Core Capabilities

1. Migration Strategy and Assessment

Each engagement begins with a detailed discovery and mapping phase to understand data models, workflows, and compliance requirements.

Core Competencies
  • End-to-end migration planning and scoping documentation
  • Source-to-target field mapping aligned with ICH E2B standards
  • Gap analysis, risk categorization, and mitigation planning
  • Definition of validation checkpoints and acceptance criteria

This ensures that migrations are not only technically sound but also strategically aligned with regulatory expectations.

2. Extraction, Transformation, and Loading (ETL)

We employ advanced ETL methodologies that maintain referential integrity and regulatory consistency throughout the migration process.

Capabilities
  • Structured extraction from legacy and active systems
  • Data transformation with standardized MedDRA and WHO-DD coding
  • Deduplication, normalization, and cleansing for quality assurance
  • Controlled loading into target databases (Argus, ArisG, custom PV systems)
  • Audit-trail preservation to maintain complete traceability

Every data point is validated at each stage to ensure conformity with both technical and compliance criteria.

3. Validation and Qualification

Validation is embedded in every migration activity. Fidelity follows a risk-based qualification methodology consistent with GAMP5 principles.

Scope Includes
  • Protocol development for Installation Qualification, Operational Qualification, and Performance Qualification
  • Parallel verification runs to cross-check record accuracy
  • Error analysis and reconciliation reporting
  • Formal sign-off and migration summary documentation

Our dual-layer validation process ensures that transferred data withstands both internal and external audits.

4. Hybrid and Multi-System Migration Expertise

Modern pharmacovigilance ecosystems rarely rely on a single platform. Fidelity's framework supports hybrid and multi-source environments.

Expertise Areas
  • Multi-source to multi-target migrations across global databases
  • E2B gateway migrations and cloud-based safety systems
  • Legacy data extraction and long-term archiving solutions
  • Integration with analytics and reporting tools for end-to-end continuity

We ensure that both historical and ongoing data remain accessible, accurate, and compliant.

5. Post-Migration Hypercare and Support

Our responsibility does not end when the data transfer is complete. FHS provides post-migration assurance to verify stability and regulatory readiness.

Support Coverage
  • System performance monitoring and issue resolution
  • Continuous verification of migrated data in live environments
  • End-user training and documentation handover
  • Regulatory submission simulation and mock audits

This ensures a smooth transition from project completion to operational adoption.

The Fidelity edge

Fidelity Health Services combines domain expertise, proprietary technology, and regulatory intelligence to deliver flawless migration outcomes.

    Distinct Advantages
  • Proven success across migrations involving millions of safety cases
  • Alignment with global frameworks including ICH E2B(R3), GAMP5, and GVP Module VI
  • End-to-end lifecycle support from planning through post-implementation
  • Automated reconciliation tools reducing manual verification effort
  • Dedicated pharmacovigilance data specialists ensuring subject-matter accuracy
  • Fidelity's precision-driven approach transforms migration risk into regulatory confidence.

Quality and Governance Assurance

All migration projects operate under the Fidelity Health Services Quality Management System, which ensures full documentation, version control, and continuous improvement.

  • Compliance with ICH, FDA, EMA, PMDA, and MHRA data integrity guidelines
  • Internal audits, CAPA tracking, and effectiveness verification
  • Secure data handling compliant with HIPAA and GDPR requirements
  • Controlled retention and archival aligned with regulatory mandates

Our governance model ensures that every migration is traceable, transparent, and fully auditable.

Your Next Step

System modernization is inevitable.
Compliance compromise is not. Partner with Fidelity Health Services to migrate your pharmacovigilance data with precision, transparency, and total regulatory confidence.

Talk to our Data Migration Experts Today

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