Every safety decision depends on data you can defend. From ICSR intake to E2B transmission and aggregate reporting, the integrity of each field, mapping, and transformation determines regulatory trust. Fidelity Health Services (FHS) delivers comprehensive Data Validation that safeguards accuracy, traceability, and compliance across your pharmacovigilance ecosystem-while embedding system-level assurance so validated data always sits on validated systems.
Safety data flows through multiple sources, databases, gateways, and reports. Without rigorous controls, issues surface late-often during inspections-creating avoidable findings, delays, and risk. FHS addresses common gaps like mismatched case data, inconsistent coding, migration defects, and malformed submissions through a structured, audit-ready validation framework.
At the same time, regulators expect proof that the computerized systems supporting these data flows perform as intended. Our approach aligns with 21 CFR Part 11, EU Annex 11, GAMP5, and current FDA Computer Software Assurance (CSA) thinking to ensure your data sits inside a controlled, validated environment.
All evidence is organized for rapid retrieval during internal and external audits.
The result is functionally equivalent, loss-free operation post-cutover.
We confirm both technical acceptance and regulatory expectations.
All checks are documented to withstand inspections.
While the page focuses on Data Validation, we embed essential Computer/System Validation so your data controls are never undermined by the platform. Our Validation Center of Excellence plans and executes risk-based validation for PV systems, upgrades, migrations, and analytics environments, using IQ/OQ/PQ where appropriate and CSA to prioritize what truly impacts patient safety and product quality.
We establish a clear validation roadmap with scope, deliverables, test matrices, and traceability. This ensures efficiency, auditability, and alignment with your procedures.
We combine automated rules, scheduled checks, and targeted manual review to maximize coverage while reducing cycle time. Exception workflows drive timely remediation, and every activity is version-controlled with electronic signature traceability.
Validation continues after go-live. Periodic reviews, change control, access checks, and audit-trail verification maintain a consistent state of control across releases and patches.
All Data Validation operates under FHS's Quality Management System and data-integrity governance, aligned to FDA, EMA, PMDA, and MHRA expectations, with CAPA-driven improvement, secure handling, and documentation suitable for global inspections.
In parallel, our Computer/System Validation governance applies 21 CFR Part 11, EU Annex 11, and GAMP5 with standardized templates and internal audits that keep records inspection-ready.
These advantages convert complex data streams into defensible regulatory evidence-on platforms that regulators trust.
Validated data on validated systems is the foundation of credible pharmacovigilance. Let's design a validation program that fits your portfolio, timelines, and inspection profile.
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