Continuous Compliance

The Only Continuous Compliance Solution

Meeting global compliance requirements is vital to your continued ability to sell your products, and to protecting your business.

Today, IT professionals control system and software updates to effectively manage resources. But compliance laws are rapidly evolving and country governments control when regulations change.

Only a solution that rapidly adapts to these changes will keep your business in compliance.

Lower Risk for Supply With Our Highly Available, Validated Service

TraceLink enables you to strategically maximize ROI, ensuring on-time access to all global markets.

We've saved customers tens of millions dollars in customization, integration, and validation costs. Here’s what sets TraceLink apart:

  • Expert staff to track and implement compliance, interoperability, and industry standards.
  • Validated integrations with systems, partners, and governments, performing tens of thousands of automated tests.
  • 32 validated integrations and 65 validated maps across 18 formats.

Our Experts Live and Breathe Track and Trace in Life Sciences


In today’s rapidly evolving compliance landscape, how can you get a 365-degree view into what’s going on in the Life Sciences industry?

Our global leadership team works with experts in the life sciences community to define requirements and develop software using GMP processes. We monitor compliance mandates across countries and develop implementation guidelines and standards for the entire industry.

Our 1,200-member Cloud Community discusses regulatory developments, product improvements, and track and trace complexities.

Community

Guaranteed Compliance With Local Regulations in 9 Global Markets

“Compliance-as-a-Service” guarantees adherence to overall serialization and barcoding requirements, addressing country compliance mandates. TraceLink guarantees this service in nine global markets, including:

  • Brazil – 2015 GS1 Brazil Automation Award winner in partnership with Roche and SPI.
  • China – 3,800 government reports created and 121 million serial numbers commissioned to date.
  • EU – Certified connection to EU hub with live customers 3 years before deadline.
  • Germany – Supports all facets of compliance reporting to the European hub.
  • India – Complete compliance that meets DGFT requirements, with instant support for DAVA when India makes formats available.
  • South Korea – 1,400 compliance documents uploaded to KPIS for 3.8 million units of product.        
  • U.S. – 108 million transaction histories for DSCSA lot-level compliance.
global compliance coverage map

Rapidly Adapting to Global Requirements


Ensure on-time access to all global markets with a rapid adoption and deployment model that addresses emerging country compliance requirements.

Evolving compliance regulations require the continuous monitoring of new laws—and changes to existing laws—in all markets that you serve.

Our Industry team is dedicated to monitoring global regulations, and our Services team supports a 24/7 customer-centered operation, with a 33-person in-house team that will grow to 85 this year.

global arrows

Validation With Systems, Partners, and Governments Saves Time and Money

TraceLink compliance modules are pre-integrated, validated, and rapidly delivered with tens of thousands of automated tests.

We verify interoperability with all customer and partner integrations in order to speed the delivery of country compliance solutions to your business. We execute system changes across the network as soon regulatory requirements change, handling all IQ and OQ validation tests. Executing PQ validation tests against the same software version and code base lets you benefit from thousands of customer tests to:

  • Reduce customization and integration, and related time, cost, and risk.
  • Benefit from automated software installation processes and documentation.
  • Eliminate the compliance cost of roughly 2,800 hours testing that would take a team of 12 dedicated QA engineers 4-6 weeks to complete for each release.
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