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Pharmaceutical Manufacturing and Packing Sourcer

Redefining Processes

Over the past few years, track and trace and serialisation have gradually become buzz words in the pharmaceutical industry due to approaching regulatory deadlines such as the EU Falsified Medicines Directive. Despite the growing awareness, serialisation is still a relatively recent concept, creating new challenges and operational changes that can differ from company to company. As a result, the entire industry is grappling with a steep learning curve on how best to deploy new systems, software and processes for serialisation in a continuously evolving environment.

One of these critical processes is software validation, which ensures serialisation software meets specifications and fulfils its intended purpose. Traditionally, a company will dictate when they want to validate their software depending on scheduled upgrades. However, the conventional approach to validation is simply unsustainable at the rate of change that is being seen across the industry.

Companies vary considerably in how many trade partners they have, as well as how many global regulations they are required to comply with. The subsequent need for Compliance-as-a-Service (CaaS) is dictating a new model, Validation-as-a-Service (VaaS), through automated validation to keep serialisation solutions constantly validated while adapting to ongoing industry and internal changes.

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Dan Walles is Vice President of Global Solutions at TraceLink where he brings to his role more than 20 years of experience in product management, solution consulting and service delivery. He has focused exclusively on the needs of the life sciences industry for the past 15 years. Since joining TraceLink in 2010, Dan has been instrumental in educating customers on the company’s life sciences cloud and partner ecosystem to enable compliance and added business value through supply chain visibility and improved patient outcomes. 

Lisa Reinhold is Vice President of Global Customer and Network Success at TraceLink. Throughout her career, she has demonstrated success in building exceptional global customer service and support organisations in highly competitive and emerging markets. At TraceLink, Lisa is responsible for understanding and advocating for the needs of customers to ensure both long-term customer success and on-going growth of the company’s network. In her role, she is passionate about fine-tuning solutions to customer expectations and building her team of skilled service professionals. 
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Dan Walles
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Lisa Reinhold
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