Digital Health & Traceability Consulting

Strategic Insight for High-Integrity Digital Systems

Introduction

Sparkwayz is a consulting firm delivering specialized expertise in pharmaceutical serialization, regulatory compliance, and computerized systems validation.

We assist governments, health authorities, and pharmaceutical industry executives in building secure, high-integrity, and globally compliant digital ecosystems.

Strategic Analysis & Roadmaps for Complex Programs

We support organizations in defining digital strategies, designing roadmaps, and structuring national or multi-stakeholder projects.

We operate in critical environments requiring strong governance, institutional coordination, and data-driven decision-making.

Serialization / Track & Trace

We design and implement pharmaceutical traceability systems aligned with global best practices (Turkey, Egypt, EU FMD). From strategic planning to technical integration, Sparkwayz supports regulators, manufacturers, wholesalers, and pharmacies. Our scope includes marking centers, national architecture, system integration, pilot phases, and operational governance.

Quality Assurance

We support organizations in implementing, optimizing, and digitalizing their Quality Management Systems. We structure controlled documentation, operational procedures, CAPA processes, internal audits, and regulatory oversight to ensure lasting compliance with international standards (ISO, GxP, FDA, EMA). Our approach delivers clear governance, risk control, and measurable continuous improvement.

Audit — Compliance, Systems & Processes

We conduct comprehensive audits covering computerized systems, GxP compliance, data integrity, operational processes, and IT infrastructure.

Our assessments identify gaps, evaluate risks, and deliver actionable and prioritized corrective plans.

Training — Capability Building & Expert Coaching

We provide specialized training in serialization, regulatory compliance, QMS, computerized systems validation, and data integrity. Our programs deliver clear, practical, and immediately applicable knowledge to strengthen team capability and long-term performance.

Computerized Systems Validation & Compliance

We deliver full validation of computerized systems (ERP, WMS, LIMS, serialization lines) according to GAMP 5, 21 CFR Part 11, and GxP requirements. Sparkwayz manages the full lifecycle: URS, risk assessments, protocols, testing, qualification, migration, and periodic review, ensuring secure, reliable, and compliant systems.

Would you like to start a project with us?

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