TraceLink · 0 reviews

TraceLink

Cloud-based pharmaceutical supply chain visibility and regulatory compliance platform

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About TraceLink

TraceLink is a cloud-based digital supply chain platform engineered for pharmaceutical manufacturers to achieve end-to-end traceability, compliance, and visibility across their entire supply chain ecosystem. As regulatory bodies including the FDA and EMA mandate serialization and track-and-trace capabilities, TraceLink enables manufacturers to meet these stringent requirements while ensuring product authenticity and preventing counterfeits. The platform provides real-time visibility into inventory movements, serialization management, and regulatory compliance across manufacturing, distribution, and retail touchpoints. AiDOOS enhances TraceLink deployment through expert implementation services, ensuring seamless integration with existing ERP and warehouse management systems. The marketplace enables scalable governance frameworks for multi-site pharmaceutical operations, optimizes supply chain workflows, and accelerates time-to-compliance with evolving regulations. Organizations benefit from centralized visibility, reduced operational complexity, enhanced data security, and improved supply chain resilience through AiDOOS's managed services and optimization capabilities.

Challenges It Solves

Meeting complex FDA, EMA, and MDSAP serialization and track-and-trace regulatory requirements
Preventing counterfeit drugs and ensuring product authenticity throughout supply chain
Achieving real-time visibility across multiple manufacturing sites and distribution networks
Integrating legacy systems with modern digital supply chain infrastructure
Maintaining data security and compliance in highly regulated pharmaceutical environments

Regulatory compliance achieved within 6 months

Counterfeit prevention effectiveness across operations

Supply chain visibility improvement with full traceability

Use Cases

Pharmaceutical Manufacturer Serialization Compliance

Large pharmaceutical manufacturers implement TraceLink to comply with FDA 21 CFR Part 11 and EMA Delegated Regulation requirements for serialized product tracking and anti-counterfeiting measures.

87% Achieve full regulatory serialization compliance

Counterfeit Prevention in Global Distribution

Distributors and wholesalers use TraceLink to verify product authenticity at every transaction point, preventing counterfeit drugs from entering legitimate supply chains.

99% Detect and eliminate counterfeit products

Contract Manufacturer Network Visibility

Pharmaceutical companies managing multiple contract manufacturers gain centralized visibility into production schedules, serialization status, and compliance metrics across vendors.

92% Increase supply chain visibility and control

Supply Chain Risk Management

Organizations implement TraceLink to identify supply chain vulnerabilities, monitor regulatory changes, and maintain business continuity through real-time event tracking.

78% Reduce supply chain disruption incidents

Recall Management and Product Traceability

Manufacturers rapidly execute product recalls by leveraging complete traceability data to pinpoint affected batches and notify distributors within hours instead of days.

94% Accelerate product recall execution time

Pricing

Pricing available on request

TraceLink pricing is customized based on your team size, integrations, and requirements. AiDOOS will get you a scoped proposal — for free.

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Key Features

Serialization and Track-and-Trace

Complete product traceability from manufacture to patient

Achieve FDA and EMA serialization compliance

Real-Time Supply Chain Visibility

Monitor inventory and shipments across all locations

Reduce supply chain disruptions by 65%

Counterfeit Detection and Prevention

Authenticate products and identify suspicious transactions

Eliminate 99% of counterfeit products from supply chain

Regulatory Compliance Management

Automated compliance reporting and audit trails

Reduce compliance audit time by 70%

Multi-Site Integration

Unified platform across manufacturing, distribution, and retail

Consolidate supply chain operations on single platform

Data Analytics and Intelligence

Actionable insights from supply chain data

Improve supply chain decision-making accuracy by 80%

Reviews

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Enterprise Readiness

End-to-End Encryption

Role-Based Access Control

Regulatory Compliance Audit Trails

Multi-Factor Authentication

Data Residency and Sovereignty

Integrations

8 total apps

Seamless integration with SAP ERP systems for inventory, production, and financial data synchronization

Cloud-based ERP integration for supply chain planning and execution

Supply chain planning and demand forecasting integration

Manufacturing execution system integration for production data

E-commerce integration for retail pharmaceutical distribution channels

CRM integration for customer and distributor management

Cloud infrastructure for data storage and analytics

Healthcare interoperability standards for healthcare system integration

AiDOOS Managed Deployment

Deploy TraceLink in

AiDOOS handles setup, CRM integration, SSO config, and user provisioning. Your team goes live — not your IT department.

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Deployments

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Adoption rate

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Post-deploy sat.

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Time to value

Prerequisites

Configuration Options

Virtual Delivery Center · A new delivery category

A Virtual Delivery Center for TraceLink

Pre-vetted experts and AI agents in the loop, assembled as a delivery pod. Pay in Delivery Units — universal pricing across roles, seniority, and tech stacks. No hiring, no contracting, no procurement cycle.

Plans from $2,000 — Starter Pack, 10 Delivery Units, 90 days
Refundable on unused Delivery Units, anytime — no questions asked
Re-delivery guarantee on acceptance miss
Pre-flight delivery sizing — you see the plan before you commit

Get a delivery plan for TraceLink What’s a Virtual Delivery Center?

How a Virtual Delivery Center delivers TraceLink

Outcome-based delivery via AiDOOS’s VDC model. Why VDC vs traditional consulting? →

Outcome-Based

Pay for results, not hours

Milestone-Driven

Clear deliverables at each phase

Expert Network

Access to certified specialists

Implementation Timeline

Discover

Requirements & assessment

Integrate

Setup & data migration

Validate

Testing & security audit

Rollout

Deployment & training

Optimize

Performance tuning

Schedule a Meeting

Frequently Asked Questions

How does TraceLink ensure compliance with FDA 21 CFR Part 11 requirements?

TraceLink provides built-in compliance features including digital signatures, audit trails, data integrity controls, and automated regulatory reporting. The platform is architected to meet FDA's electronic records and signatures regulations. AiDOOS can assist with compliance configuration and validation for your specific regulatory requirements.

What is the typical implementation timeline for TraceLink?

Implementation typically ranges from 3-6 months depending on organizational complexity, existing system integrations, and number of sites. AiDOOS marketplace partners offer expedited implementation services, change management support, and staff training to accelerate deployment and minimize business disruption.

Can TraceLink integrate with our existing ERP system?

Yes, TraceLink integrates with major ERP systems including SAP, Oracle, Infor, and JDA through pre-built connectors and APIs. AiDOOS provides integration consulting to ensure seamless data flow between TraceLink and your existing IT infrastructure without disrupting current operations.

How does TraceLink prevent counterfeit drugs from entering the supply chain?

TraceLink uses serialization, track-and-trace, and transaction history verification to authenticate products at every supply chain touchpoint. The platform identifies suspicious transactions, unauthorized suppliers, and diverted shipments. Combined with blockchain-enabled verification, it provides 99%+ counterfeit prevention effectiveness.

What support and training does AiDOOS provide for TraceLink implementation?

AiDOOS marketplace offers comprehensive implementation services including system configuration, ERP integration, staff training, change management, and ongoing optimization. We provide dedicated support during deployment and post-launch governance to ensure maximum platform value and regulatory compliance.

How does TraceLink handle product recalls?

TraceLink enables rapid recall execution by providing complete product traceability. Organizations can instantly identify affected batches, notify all impacted distributors and retailers, and track recall completion status in real-time, reducing recall execution time from days to hours.