With regulations like the Drug Supply Chain Security Act (DSCSA) in the United States and the European Union Medical Device Regulation (EU MDR) requiring stringent traceability, the need for robust technology solutions has never been greater. Jag Lamba, CEO and founder of Certa, discusses with OSP how the company’s platform is designed to help pharmaceutical companies navigate these challenges and enhance the efficiency of their supply chains.
How can pharmaceutical companies effectively track and trace their products through the supply chain to comply with regulations such as the DSCSA and EU MDR?
Pharma companies need to build transparency into their processes. Third-party relationship management (TPRM) software makes it possible to gain visibility into products’ paths along the supply chain, from origin to sale, and keep track of all relevant documentation to make regulatory reporting or audits go quickly and smoothly.
What are the key challenges faced by pharma companies in maintaining visibility and accountability across a global supply chain with multiple parties and regulatory environments?
The extensive network of third parties that make up a pharmaceutical company’s supply chain makes maintaining transparency and elevated levels of accountability a cumbersome task—even an impossible one without tools purpose-built to solve this problem. And while the regulatory environment in the US alone is hard to navigate, layering on regulations from other regions when a supply chain is fully global compounds the complexity exponentially. There’s little to no standardization in reporting requirements among these regulations.
Without a system that can collect data from vendors and other parts of the supply chain, monitor regulatory environments (and the company’s adherence to them at any given time), store the relevant documentation, and provide reports in keeping with regulations, pharma companies are hard-pressed to achieve the level of transparency needed for efficient, compliant activity.
How does Certa’s platform help pharma companies meet the traceability and transparency requirements for compliance with the DSCSA and EU MDR?
The Certa platform helps enable transparency at each crucial juncture. Our platform automates key parts of data collection—automatically pulling available data, prompting third parties to fill out information that’s missing, and making sure it’s stored in the right place and made easily available—reporting, and creating workflows to automatically screen current and new third parties for relevant compliance risks. It offloads the burden of information gathering, monitoring, and reporting from employees while simultaneously enhancing the level of transparency through the robust data it makes available at a glance.
What are the benefits of achieving greater traceability and transparency in the healthcare supply chain beyond regulatory compliance?
The efficiency and related cost savings pharma companies can realize when their supply chain embraces transparency are enormous. Tracing products manually is a time-intensive process—which makes it a resource-intensive process as well. Hours spent sending emails, combing through paperwork, and trying to track down people at other organizations on the phone can take hours and hours—or it can be done simply by going into the TPRM and searching for the product, having all of the pertinent info populate on a single screen at once.
Additionally, transparency and traceability help reduce risk at a pharmaceutical company. With clear access to so much data, and automation systems able to flag risks hiding in that data even before humans can catch it, risk managers can act proactively and eliminate potential compliance violations, divest from a vendor, or partner that isn’t likely to meet compliance or is not dependable.
What role does technology, such as blockchain or AI, play in enhancing the traceability and transparency of pharmaceutical supply chains?
Technological innovations are crucial to enabling transparency and making it feasible for pharma companies to implement. AI in particular has enormous potential and is already being used in the space. AI can parse regulatory documents and generate workflows built around the requirements it finds. Companies can apply rules and modifications to the AI across multiple parts of these workflows, saving time when dealing with large-scale processes or implementing changes to existing workflows. Technology such as Certa’s SmartFill AI can also automate the form completion process, utilizing vendor-provided data, publicly available data, and even generative AI capabilities to reduce cycle times. The data-gathering process is crucial for transparency but has been one of the most cumbersome steps in the past; now, the digital transformation we’re seeing in the space is changing all that.
How does Certa integrate with existing supply chain systems and processes used by pharmaceutical companies?
Certa has over 130 native integrations with commonly used platforms. Most companies in the pharmaceutical space will see little to no friction when it comes to integrating Certa into their existing data and application ecosystem. Further, our API and RPA frameworks are open with no-code capabilities, enabling you to integrate with new APIs in minutes if needed.
How can pharma companies balance the need for compliance with regulatory requirements and the need for a more efficient and resilient supply chain?
The good news is that compliance and efficiency or resiliency are not mutually exclusive needs. The tools that pharma companies can put in place to meet compliance regulations will also streamline onboarding, enhance risk management, and help risk and supply chain professionals react more quickly than ever when an issue arises. The world’s supply chains are in an incredible moment of innovation right now, and pharma companies should not be left out in the cold; you shouldn’t have to settle for meeting one of those needs when there are capabilities out there that can bolster compliance, efficiency, and resilience all at once.
