Achieve orchestrated traceability across your supply chain for compliance and efficiency.
Roughly 50 countries have enacted pharmaceutical product coding and/or serialization laws which are remarkably disparate and incongruous. These product coding complexities lead to client confusion, added effort to comply, and a need for interpretation in some cases (e.g., with the U.S. Drug Supply Chain Security Act). GS1, the international organization that develops and maintains standards for supply and demand chains across multiple sectors, has not been adopted as the de facto global standard all countries must adhere to. The largest ERP systems have traceability deficiencies which have led to the rise of niche software providers to supplement a company’s ERP. The pharmaceutical industry’s ability to agree on the details of the data standards has been hampered as manufacturers, wholesalers, distributors, hospitals and pharmacies all weigh in with competing interests.
The disparate pharmaceutical traceability laws and their delayed implementation have fueled related emergent industry issues: drug counterfeiting, product theft and tampering – all of which end up costing the life sciences companies millions in lost revenue. Many software and services companies claim to be able to help a pharmaceutical become compliant, but struggle because their solutions are immature and incomplete. Pharmaceutical companies are resigned to the fact that compliance will mean more cost with somewhat reduced operating efficiencies; at least initially, but still seek a ROI to leverage their considerable ERP investment. As more countries enact traceability mandates, the issue will intensify.
What we do to solve the problem
CSC helps pharmaceutical companies achieve not only regulatory compliance in markets, such as China, Brazil, the U.S. and others, but more importantly to create value beyond compliance. Value creation in pharmaceutical traceability is a novel and even a radical idea because most pharmaceutical companies in our view are thinking about how to comply, not how to comply and create value.
CSC’s pharmaceutical traceability solution is based on our unique point of view, which is in part:
- Traceability has to be part of a broader and more strategic supply chain perspective which considers customers, orders, inventory, systems and trading partners
- Most traceability data that a company needs (perhaps as much as 80%) resides beyond its four walls with partner systems
- Data orchestration (not just data management) inside and outside the four walls is critical for traceability success
- More disparate pharmaceutical traceability market requirements will emerge as more countries acknowledge the value of protecting patients and consumers
- Multiple industries, such as Consumer Packaged goods, Aerospace & Defense, and Food & Beverage face similar traceability challenges
CSC has a pharmaceutical traceability platform which:
- Is built consistent with the GS1 global healthcare standard
- Complements a client’s ERP
- Augments capabilities of several carefully chosen eco-system partners
- Integrates with trading partners such as contract packagers and 3PLs
- Reflects a Service-Oriented Architecture (SOA) approach
- Leverages strengths in visibility, analytics, risk management
- Blends CSC’s capabilities in Cybersecurity, Big Data & Analytics, Machine-to-Machine, Cloud and Mobility
Pharmaceutical companies are starting to line up behind firms they believe will bring resources and capabilities along with global scale. CSC is one of those firms. Other companies offer niche solutions, or implement another company’s technology, or can only offer consulting resources to support a project.
At CSC, we understand traceability compliance is far more than a packaging line conversion and a label change. It requires an orchestrated program approach which involves important internal stakeholder groups including manufacturing, packaging, supply chain, and external groups like third-party transportation and logistics providers and downstream trading partners.
For more information, please contact us.