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Serialization as a Bridge Between Life Sciences and Healthcare
Figure 1: Supply Train Traceability
Supply chain traceability integrates manufacturing, warehousing, and distribution
processes and customers to provide the ability to track and trace supplies and
products along the value chain.
CFO–COO Manufacturing Supply chain Sales
Product Lot/batch Product
operations traceability genealogy
Inbound/
Warehousing and logistics Product Product
distribution Outbound/ tracking tracking
logistics
Raw material/ Suppler batch
Component
component supplier traceability
product
genealogy
Customer account Provide PTA Recall Returns
Problem
management visibility mgmt mgmt
assessment
and analysis
Performance
Event-driven analytical and visibility supply chain performance management
management
and assess them, create and evaluate strategies, and then implement the best Table 1: Challenges by Line of Business
solution. Often, this will necessarily be in conjunction with a partner or
partners, emphasizing the need for rapid and secure collective intelligence
Key Performance
technologies. Not all companies are able to achieve these capabilities or end-
Line of Business Key Challenge Indicators Affected
points sufficiently; an outline of certain typical situations is shown in Table 4.
Operations (including Chief How do I manage company- Compliance
Therefore, when assessing technologies to improve strategic problem
Operating Officer [COO]) wide risk in light of emerging Customer satisfaction
mandates? Brand protection
assessment and response, it is important to keep in mind the need to:
Financial risk
Manufacturing How do I connect and trace a Upstream traceability
identify and list end products based on information concerning particular
finished product with the raw Recall accuracy
manufacturing inputs and determine the product whereabouts—whether
materials, components, and Global visibility
that is with an immediate customer or further downstream—based on batches used during its Regulatory compliance
deliveries and/or pallet, case, or item information; manufacture?
implement electronic recall notifications for affected business partners,
Logistics and distribution How do I ensure secure Counterfeiting
which include specific details on recalled products from batch, lot, or pallet
distribution of products, prevent Forward logistics
level, or even cases or individual items if serialized; and
and detect counterfeiting, and Response time
manage performance, including problem assessment and analysis, to
address reverse logistics? Reverse logistics
enable accurate determination of the root cause of a problem and ensure
Product safety/sales How do I respond to a possible Response time
quality, safety, or compliance issue Customer satisfaction
proper scope and scale of the response.
and ensure customer satisfaction? Administrative cost
Risk avoidance and
The current trend for out-sourcing, coupled with the technology and industry-
containment
specific expertise required, means that leading pharmaceutical companies are
increasingly looking to partner with an IT solutions vendor to achieve secure able to benchmark the current practices of life sciences manufacturers
and visible supply chain management. Specific attributes of a partner will vary against best-in-class, with measurable, quantifiable value from the
according to the needs of each pharmaceutical firm, but there are some key implementation identified as the business case for adoption; and
qualities that are universal: operates within a large ecosystem of partners to ensure that all business-
essential needs are covered, with a proven track record of success.
able to deliver end-to-end solutions tailored for the life sciences industry,
with implicit best practices; Bridging the Chasm
can assure lower total cost of ownership through integration with There are issues within the wider healthcare arena. Many of the leading,
enterprise resource planning; revenue-generating blockbuster pharmaceuticals are facing imminent
broad adoption by industry leaders across the value chain in the life patent expiry and will therefore be threatened by competition from
sciences industry; generics firms. In order to continue creating, testing, manufacturing, and
PHARMACEUTICAL SERIALIZATION & AUTHENTICATION
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