Supply chains are the lifeblood of any life sciences company that manufactures products. Ensuring products are on the shelf and available when needed at the point of care requires significant planning and coordination. Life sciences companies must ensure they have the appropriate inventories of raw, work in progress (WIP) and finished goods and materials available and on the supply chain to meet client demand — and do all this while ensuring that the manufacturing and distribution processes align to trade regulations (i.e., ITAR) and laws (i.e., FDA’s DSCSA, Brazil’s Federal Law No.11.903, European Parliament and Council’s Directive 2011/62) while verifying that these processes align to the appropriate regulatory requirements (i.e., FDA, EMA, DMA, PMDA) within the various global geographies where their products are distributed. For example, life sciences companies need to guarantee products that originate in one country are not shipped to another country as well as check that product label requirements align with the packaging requirements from regulatory authorities.
Compliance with various trade regulations and regulatory frameworks is important as there can be significant penalties for non-compliance. These costs can be a combination of financial (i.e., fines, product seizures and legal costs), operational (i.e., supply chain disruptions and recalls) and intangible (e.g., product switching to comparable therapeutic), as well as reputational damage.
Companies rely on ERP systems to manage goods flowing through the supply chain, serve as the single source of truth and provide proof of compliance with these regulations. The challenge with using only ERP systems is that their core function does not provide real-time visibility into supply chain compliance. To enable this real-time view and more automated flow of data, track-and-trace solutions can be paired with already deployed ERP systems as they are built with ERP integration in mind.
Through the implementation of a track-and-trace solution, companies can:
- Manage their supply chains in real time
- Provide greater visibility into the dark areas of their supply chains
- Enable improved insights and decision-making
By working with life sciences clients, we can further extend these solutions to monitor temperature-sensitive goods in real-time and even ensure that inventory is consumed using a First Expired First Out (FEFO) method to reduce spoilage.
When implementing track-and-trace solutions for life sciences companies, it’s important to focus on one aspect of the process, whether it be the area of greatest need, the area with the greatest potential ROI or where there is a compliance or regulatory requirement. For some companies, the need may be to improve the management of their raw, WIP and finished goods and materials. Other companies may view improved visibility within the supply chain to reduce spoilage as their objective, while others may view trade compliance as the goal. Whatever the intent, the focus is to ensure that a solution is implemented in the enterprise that is done thoughtfully with scaling and potential use case expansion in mind.
Once implemented, extending track-and-trace solutions into other areas of the enterprise adds value to the company and improves the overall ROI for the business. Additionally, these solutions should not focus solely on track-and-trace but serve use cases to provide visibility into corporate assets (i.e., lab and warehouse equipment). The potential use cases for track-and-trace are expansive. Also, track-and-trace solutions provide the foundation for the next stage in the evolution of supply chains by being one of the enablers of the cognitive supply chain.
Companies need to get as much as possible out of track-and-trace solutions and not feel like there is a limit on what can be implemented. By implementing and leveraging these solutions, value can be brought to the enterprise by delivering on use cases that require visibility and traceability at its core and can be extended to manage sensitive (i.e., temperature) products to ensure optimal product efficacy when used to deliver patient care. A solution can provide no better value than when it delivers cost savings to life sciences companies offering therapies to market while also telling clients that the products used to deliver care have the highest efficacy.
Glossary
- ITAR: International Traffic in Arms Regulations
- FDA: Food and Drug Administration
- DSCSA: Drug Supply Chain Security Act
- EMA: European Medicines Agency
- DMA: Danish Medical Agency
- PMDA: Pharmaceuticals and Medical Devices Agency
- ERP: Enterprise Resource Planning
