By Louis Roy / September 2023

The FDA has just offered pharma companies a one-year reprieve to comply with the Drug Quality and Security Act (DSCSA). The deadline is now November 2024. While many businesses are praising the extra year to better prepare, it is still critical to act now. The strategic implementation of traceability technologies and workflows to ensure regulatory compliance takes time.

Serializing products at the package level is, indeed, the hardest step toward complete, end-to-end tracking. However, the inroads pharmaceutical companies have made to more transparent supply chains is impressive. But the work is far from over.


Beyond the compliance requirements, there are many more benefits for improving upstream and downstream visibility through digitized supply chains. Real-time and accurate product traceability will become a major competitive edge for business agility and operational performance as well as generate unprecedented cost savings to optimize companies’ bottom lines. What’s more: complete supply chain visibility will be instrumental in helping pharmaceutical brands to make their operations much more sustainable, enabling them to better hit their ESG targets and avoid consumer greenwashing. In the past, the traceability of pharmaceutical products was siloed at best and often relegated to less-than-complete in-house systems, making third-party interoperability a headache, to say the least.

In 2010, OPTEL decided to tackle the traceability challenge head-on. We started an incredible journey to make sense of supply chain traceability by leveraging data across all stakeholders to help resolve contemporary issues and disruptions that businesses face in the world today. Over the decades, we have invested many resources in developing our cloud-based intelligent supply chain platform, now named Optchain. This powerful end-to-end traceability platform was developed with the help of incredible partners, recognized research centers, consulting firms, influential organizations, such as the WEF, WHO, OECD, and UN, public institutions and most importantly, customer feedback across multiple sectors, including the pharmaceutical industry


Over the years, OPTEL has successfully supported the pharma industry to comply with worldwide T&T regulations, deploying more than 6000 track-and-trace solutions around the globe in this ever-changing market. In addition, we have acquired three companies to complete our technology stack to support advanced and niche needs as well as new markets. We have worked equally hard to ensure that Optchain remains seamlessly interoperable with renowned third-party software solutions and hardware that are future-proofed for Industry 4.0 and Industry 5.0 integrations.

OPTEL is still working on delivering projects for the DSCSA deadline. We have a large team of technology and compliance experts to assist your business throughout the transition. While the deadline does loom, we are nevertheless geared toward the future to align our upcoming R&D initiatives to support life science industries even further as their markets evolve with the times.

For those who know me personally, you know that my mission is to make the world better for future generations. While I have built OPTEL to become the world’s best supply chain traceability company, my vision—and my heart—has always been centered around making value chains more sustainable. That is why we are a Certified B-Corp and intend to remain that way. I firmly believe that successful business operations and sustainability can go hand in hand. Let’s seize the tremendous opportunities the DSCSA offers to keep people and the planet safe—all while allowing us to build more robust and resilient pharmaceutical supply chains.



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