Selecting and implementing the right safety database is one of the most critical decisions for any pharmacovigilance operation. The system must capture, manage, and report safety data across global markets with accuracy, consistency, and full regulatory alignment. A poor database decision or an unvalidated implementation can lead to inefficiencies, compliance risks, and costly inspection findings.
Fidelity Health Services (FHS) provides comprehensive Safety Database Selection and Implementation Services designed to help life-sciences organizations establish robust, validated, and future-ready safety systems.
Our expertise spans from technology evaluation to post-deployment optimization, ensuring every implementation aligns with both business objectives and global pharmacovigilance requirements.
Pharmaceutical and biotech companies operate in a dynamic environment where global regulatory authorities continuously evolve data submission and reporting requirements. The chosen database must adapt to new standards while maintaining high performance and data integrity.
Fidelity addresses these challenges by combining domain expertise, system knowledge, and regulatory insight to deliver safety databases that are compliant, efficient, and scalable.
Fidelity's consultants perform a structured assessment to identify the safety database that best aligns with organizational requirements, size, and regulatory obligations.
Our systematic evaluation framework ensures clients invest in the right technology for long-term sustainability and compliance confidence.
Once the appropriate platform is selected, FHS executes a full-cycle implementation using a standardized and validated approach.
Each implementation is carried out under controlled change management with full traceability from design to deployment.
Validation is a regulatory imperative for all GxP systems. Fidelity's Computer System Validation (CSV) and Computer Software Assurance (CSA) teams ensure every database implementation is inspection-ready.
All validation activities align with 21 CFR Part 11, EU Annex 11, and GAMP5 standards, ensuring audit confidence.
Modern drug safety operations demand seamless data flow across systems. Fidelity enables integration between safety databases and key platforms across the regulatory landscape.
These integrations eliminate data silos and enable a unified, transparent safety ecosystem.
Implementation success depends on how effectively end-users adopt the system. Fidelity provides comprehensive training and hypercare support to ensure operational continuity.
Our support model ensures that clients gain maximum operational value from their investment.
Fidelity Health Services combines regulatory expertise, technical mastery, and operational experience to deliver safety database implementations that stand out for precision and reliability.
Our focus is not only on technology enablement but also on delivering systems that enhance pharmacovigilance efficiency and compliance assurance.
Every implementation is governed by Fidelity's Quality Management System (QMS) and validation governance framework.
A reliable safety database is the foundation of every pharmacovigilance operation. Partner with Fidelity Health Services to implement validated, scalable, and regulator-trusted safety systems tailored to your organization's global needs.