By basing the Life Sciences Cloud on AWS, we can provide our customers with global compliance requirements in a GxP environment with the least amount of risk. That is unique in our industry. 
Dan Walles Vice President of Global Solutions

TraceLink, headquartered in Massachusetts, offers the world’s largest track-and-trace network for connecting the life sciences supply chain and eliminating counterfeit drugs from the marketplace. Tracelink’s Life Sciences Cloud platform ensures compliance throughout the global life sciences supply network. TraceLink is a key part of the global pharmaceutical supply chain, with more than 440 pharmaceutical manufacturers, wholesale distributors, hospitals, and pharmacies using the company’s SaaS solutions, which are natively integrated with Amazon Web Services (AWS).

Drug manufacturers today must comply with regulations designed to prevent drug counterfeiting and other threats that present a danger to public health. These regulations present data-exchange and scalability challenges for these companies, which must also comply with Good Laboratory, Clinical, and Manufacturing Practices (GxP) laws and global track-and-trace regulations. “We knew our customers were facing a big challenge around scalability in terms of product serialization and track and trace,” says Dan Walles, vice president of global solutions at TraceLink. “We also knew that, in order to scale to provide data-exchange capabilities to hundreds of thousands of companies, an on-premises or traditional hosted environment wasn’t going to work.”

To help its customers solve the challenges that come with tracking every package of medicine across the global supply chain, the company needed a platform with simple connectivity, complete end-to-end visibility, and rich business collaboration for all network participants. Enabling this network required TraceLink to create a reliable, secure, and elastic platform that could handle significant spikes in traffic. TraceLink determined it needed the elasticity of the cloud to help its customers keep pace with constantly changing track-and-trace regulations—all while maintaining compliance with GxP.

TraceLink chose the AWS Cloud to support its TraceLink Life Sciences Cloud solution, using the AWS GxP Compliance program to help meet customers’ compliance needs. “We chose AWS because it met our security, scalability, and reliability requirements,” says Walles. “And we liked the idea of using a multi-tenant web services environment because it could help us rapidly deploy software releases as track-and-trace regulations change.” The TraceLink Life Sciences Cloud helps life sciences companies and their partners fight drug counterfeiting and diversion. The solution safeguards product quality and ensures compliance with global track-and-trace regulations—including GxP—through complete drug traceability from ingredient to patient.

TraceLink uses Amazon Elastic Compute Cloud (Amazon EC2) instances to support its solution. The instances are fully qualified and controlled using TraceLink’s Amazon Machine Images (AMIs) and GxP-validation processes, which leverage the automated quality and security capabilities of AWS. Logs of instance-related activities are generated automatically by AWS and retained by TraceLink. The company’s GxP production and packaging data—as well as distribution and supply chain traceability data—is stored in Amazon Simple Storage Service (Amazon S3).

TraceLink uses a variety of other AWS products to support its Life Sciences Cloud, including Amazon Elastic Block Store (Amazon EBS) to provide persistent instance storage and backup, Amazon Relational Database Service (Amazon RDS) to retrieve large amounts of serialization and business data, Amazon Simple Queue Service (Amazon SQS) to work within the context of the platform’s loosely coupled, distributed, scalable architecture, Amazon Redshift for satisfying the business-application needs, and Elastic Load Balancing to deliver dynamic application capacity and availability.

Tracelink also uses Amazon DynamoDB, Elastic IP addresses, and AWS Identity and Access Management (IAM), which help ensure its Life Sciences Cloud can satisfy electronic records and signature requirements.

Relying on AWS, the TraceLink Life Sciences Cloud can fully support the GxP-compliance requirements of hundreds of pharmaceutical companies and their partners. “The TraceLink Life Sciences Cloud takes advantage of the elastic nature of AWS while ensuring data consistency for mission-critical operations, even at massive scale. We have a level of elasticity we wouldn’t get in a traditional on-premises environment,” Walles says. “Instead of being constrained by the design and hardware running our solution, we can add more capacity or compute power as needed. In an on-premises environment, we would have to size our environment based on peak usage and pay for a lot of unused capacity.”

The company can also scale to meet the requirements of pharmaceutical companies of all sizes. “With the flexibility and scalability we have using AWS, our solution can scale up to satisfy the needs of some of the largest drug companies in the world, but it can also scale down to support a local, independent pharmacy,” Walles says. In addition, the organization can offer a data-exchange platform for more than 240,000 companies. “Rather than having to create thousands of point-to-point integrations between a customer and all of its trading partners, we only need to create a single integration to our Life Sciences Cloud on AWS for a single customer to exchange data with its ecosystem of trading partners,” says Walles. “That’s just not possible in a single-tenant or on-premises architecture.”

By using AWS, TraceLink can also meet its customers’ cybersecurity needs. “The investment AWS has made in security far exceeds any investment our customers could make on their own,” says Walles. “Our customers know they’re getting industry-leading security capabilities on AWS.”

TraceLink has been able to leverage the cost-efficient utility model of AWS to offer an innovative commercial model for its customers. "Using AWS lets us align our fee structure to the value created for our customers,” says John Kordash, TraceLink’s chief information officer. “Companies only have to pay for what they use and can turn on new business modules and enable new connections in minutes, eliminating the traditional, large, up-front capital outlay for enterprise software and supporting hardware infrastructure. For our customers, this can mean tens of millions of dollars in cost savings. For the patient, it can mean the difference between getting the medicine they need or not.”

By running on AWS, TraceLink reduces costs and creates business value for companies of all sizes. For example, TraceLink can help a pharmaceutical company improve outsourced manufacturing performance by quickly integrating it with network partners through a single connection to the TraceLink Life Sciences Cloud, saving the company four years of time and more than $9 million in integration costs compared to traditional point-to-point methods. A company facing global track-and-trace compliance requirements for 50 million drug products can save more than $1 million in IT infrastructure and maintenance costs annually by working with TraceLink to support its 300,000 daily transactions and 24 TB of storage.

Using AWS also provides efficiencies and cost benefits to TraceLink’s internal business operations. TraceLink has built a global cloud-management platform that automates cloud operations and eliminates the need to maintain a physical global IT infrastructure. “With AWS, we can save hundreds of hours per year in IT staff time, a benefit that will keep growing as we expand,” Kordash says. Now, the TraceLink operations team can focus on improving customer service and identifying new application opportunities by analyzing customer usage, transaction histories, and network operational patterns. “By basing the Life Sciences Cloud on AWS, we can provide our customers with global compliance requirements in a GxP environment with the least amount of risk,” says Walles. “That is unique in our industry.”

Learn more about how AWS is used in the life sciences industry and see additional details on the AWS GxP-compliance program.