Your life sciences data flow must match the movement of your physical products

The rigid boundaries between internal and external systems in integrated medicine supply chains are becoming increasingly blurred – and in some cases are disappearing entirely.

Critical steps and data flows now play out within a connected network of CMOs, 3PLs, logistics carriers, wholesalers, and external mandatory reporting platforms. This means that events that were previously handled within one internal system are increasingly created, updated, and validated across multiple external systems.

Multiple data handoffs increase complexity

For example, a CMO might create and print serial numbers on their packaging line and transmit them to the brand owner’s repository, while shipping, receiving, verification, returns, and additional events – for example temperature-excursions and other alerts – that are generated by 3PLs, carriers, wholesalers and national verification networks, all need to be made visible in real-time.

The result is an end-to-end record that is built through many handoffs, where each partner creates and validates part of the “digital truth” of the physical product’s journey – which is then synchronized back into the marketing autotization holder’s internal ERP and traceability systems.

– The integrated supply chain thus creates new complexity and requires enhanced processes and data quality. A clean data flow, shared standards, and end-to-end integration are necessary to keep the digital record aligned with the physical supply chain. If not managed well, this also increases the need for manual intervention and introduces more risk, says Christoph Krähenbühl, Regional Vice President at NNIT.

Extending the scope of traceability

At the same time, there is an increased expectation from regulators that life science companies exert greater control over the traceability of their products, from raw materials to the individual patients and every step in between.

These expectations also create additional barriers to entering new markets. Many requirements are similar from market to market, but some are not, and incorrect assumptions lead to costly delays.

– We’re moving from documents to data and extending traceability all the way to the patient. Companies that prepare now will scale faster and adapt more easily. When supply-chain data is structured and trustworthy, it becomes the foundation for, rather than the barrier to digitalization and effective use of AI, says Christoph Krähenbühl, Regional Vice President at NNIT

The solution: An integrated data flow

A common first response is to address problems as they arise, in a piecemeal fashing, possibly adding more manual processes. But approach introduces risk and is unsustainable. A more effective strategy is to ensure an integrated, collaborative digital supply chain is established that matches the physical world.

This is achieved through aligned definitions, standards, integrated processes across domains, and reliable interfaces so the digital record stays accurate through every handoff.

– By establish the full understanding of your specific context and needs, we can clarify the underlying assumptions and ensure that you meet the business requirements for each market, says Christoph Krähenbühl.

Faster market entry and safer medicine

When data standards are aligned and handoffs between different systems automated, you not only reduce risk, but also reduce the time it takes to get a product ready for a new market. In Christoph Krähenbühl’s experience, companies often underestimate the compelxities involved when expanding from one market to another:

– Many companies make assumptions based on their previous experience when entering into a new market. However, while regulatory requirements may look similar at the high level, they can vary significantly in detail – and that can derail and delay a product launch.

Ultimately, a well integrated supply chain with a reliable data flow benefits both pharma companies and patients.

– Serialization and full traceability protect patients by ensuring every product is legitimate. Traceability provides the basis for a step change in efficiency and visibility in the medicines supply chain, says Christoph Krähenbühl.