Welcome to Raylink

Pharma Serialization & Computer System Validation Experts

At Raylink, we deliver end‑to‑end pharma serialization solutions that ensure product traceability, supply chain security, and compliance with GS1 standards. Our team of highly experienced technical experts have worked extensively with multiple serialization platforms like Tracelink, Systech Unitrace providing tailored solutions that meet the unique needs of regulated industries.

Our Specialized Expertise 

At Raylink, we are recognized as one of the recommended technical experts for Tracelink and Systech serialization systems. We provide Serialization & Traceability consulting, implementation, and integration services across Level 3, Level 4, and Level 5 systems, enabling seamless connectivity between packaging lines, enterprise systems, and regulatory networks. We deliver end‑to‑end services across these platforms, ensuring seamless compliance and operational excellence. 

Our comprehensive support includes:

• 📂 Master Data Management – accurate setup and maintenance for smooth serialization operations

• 🧪 Testing & Validation – rigorous testing to ensure system reliability and compliance

• 🚀 Production Deployment – expert guidance for successful go‑live and rollout

• ⚠️ Alert Management – proactive monitoring and resolution of serialization alerts

• 🔗 EPCIS Issue Resolution – handling data exchange challenges to maintain supply chain integrity

Computer System Validation (CSV) 

Software validation is one of the most critical and regulated aspects of the pharmaceutical industry. At Raylink, we offer expert consultation and execution of CSV strategies aligned with FDA, EMA, and other international guidelines.

Our CSV Expertise 

📊 Validation Strategy & Consultation – We design and implement validation frameworks aligned with FDA, EMA, MHRA, and WHO guidelines, ensuring your systems meet international regulatory expectations.

📑 Risk‑Based Validation – Tailored approaches that balance compliance with efficiency, reducing unnecessary effort while maintaining audit readiness.

⚙️ Software & Hardware Validation – Comprehensive validation services covering both IT applications and infrastructure, ensuring reliability across the entire system landscape.

💻 Electronic Validation – Expertise in ValGenesis, the industry‑leading paperless validation tool, enabling streamlined documentation, faster approvals, and full compliance with 21 CFR Part 11 and Annex 11 requirements.

🔒 Audit & Inspection Readiness – Validation deliverables designed to withstand regulatory scrutiny, ensuring smooth inspections and minimizing compliance risks.

  Our Mission

To empower pharmaceutical companies with robust, compliant IT systems that safeguard patient safety, ensure product integrity, and meet the highest regulatory standards.