Pharmaceutical Commerce - November/December 2016 - 21

Supply Chain/Logistics
actual serial number on the sides of each
bottle. These helper codes are read with the
assistance of a Fanuc robotic arm that picks
up the bundle, presents it before a camera,
and then places several bundles in a case.
According to industry experts, such systems
can double the cost of a serialization project
on a packaging line. Mindful of the capital
expense of such systems, and mindful also
that many pharma packaging lines run at
fairly slow speeds, serialization equipment
vendors have also developed manual case
packing stations: An operator manually
loads a batch of cartons, records the serial
numbers digitally with a scanner, and then
generates a case label that contains the
identified serial numbers. For their part,
wholesalers are telling pharma manufacturers
that they will insist on aggregation to accept
deliveries; in the final analysis, however, drug
shipments still have to go through to meet
patient demand, so some workarounds will
eventually be established.
Data at the enterprise level
Packaging and manufacturing engineers,
with a boost from automation experts,
will work out the details of implementing
s e r i a l i z a t i o n i n co m i n g m o n t h s . A
pharma manager concerned with DSCSA
compliance, however, has to pay attention
to the IT systems that take the packagingline data, add the EPCIS event information,
and then make it available to trading
partners and others. Third-part logistics
providers (3PLs), contract packagers play a
role as well, depending on how the pharma
brand owner assembles its network. As
products move down the supply chain to
pharmacies, hospitals and other dispensers,
these organizations need enterprise-level
data management as well. This level of data
management is a hotly contested business
arena as well.
By some measures, TraceLink is pulling
away from the pack of traceability vendors.
The company is not shy about broadcasting
its project wins and customer base-
currently at 105 pharmaceutical and contract
manufacturing organizations, plus more than
300 downstream customers. It is operating
in both the US and Europe, as well as several
Asian countries.
A key to TraceLink's rapid adoption was its
early decision to build it traceability platform
in the cloud, with a true, multitenant
architecture running mostly on Amazon Web
Services. Pharma companies and distributors
have been encouraged by TraceLink to file
account information with it (whether or not
they are TraceLink customers), and more
than 240,000 users have done so, says the
company. The cloud-based account provides
ready access for up- or downloading
serialized data; subsequently, those users may
opt to have TraceLink's Life Sciences Cloud
manage serial-data records.
Also charging into the market is SAP,
which announced the Advanced Track and
Trace for Pharmaceuticals (ATTP) platform
a year ago. ATTP updates an earlier SAP
traceability platform built on SAP's Object

Event Repository. Currently, SAP says
that many of its clients have opted for an
on-premise implementation of ATTP. This
fall, word came out that it is tailoring ATTP
to a cloud-based format, with Deutsche
Telekom among its cloud-based providers.
As traceability business in pharma ramps
up, more players are crowding into the
arena. Longtime participants such as Axway,
with its Global Trade Manager platform,
Frequentz, with its Information Repository
and Intelligence Server (IRIS), rfXcel, with its
Compliance Management offering, have won
pharma distribution business. Verify Brand,
a participant in earlier stages of pharma
traceability, is building out a services team and
has substantial serialization business outside
pharma. Systech, which has a large base of
customers for its packaging line technology,
has revamped the formerly named Systech
Guardian and Sentry software as UniTrace.
New players, such as TrackTraceRx, based in
Orlando, FL, have appeared.
A growing number of vendors based in
Europe, where serialization projects ranging
from pharmaceuticals to wine and other
consumer goods have been undertaken, are
also competing for global business. Among
these are Adents and TradeTicity. Recently,
Systech announced a partnership with
Servicepoint Oy, an automation vendor in
Finland. Arvato Systems, the IT arm of the
Arvato group, a major distributor in Europe,
is marketing a traceability platform based
on its experience in developing some of the
software used in Germany's SecurPharm
project (Germany's approach to FMD
Ment ion should also b e ma de of
companies that put an emphasis on
warehouse or related "edge" systems that
are designed to carry serialization data from
the packaging line through to warehouse
inventory and beyond. Two companies in this
space, ROC IT Solutions and Acsis, have been
winning pharma business.
Yet another category of service providers
are IT systems integrators or consulting
firms that assist pharma companies building
out their traceability platforms. Navitas, a
New Jersey-based systems integrator, is
working with Axway on implementations.
Movilitas, a European-based firm, has a
close relationship with SAP, while Xyntek,
based in Pennsylvania, is the North American
distributor of Antares Vision software
and hardware. Excellis Health Solutions, a
strategic consulting firm, has been guiding
corporate-level planning and runs a regularly
scheduled meeting, Global Track & Trace,
for industry participants. Another company,
Vantage Consulting Group, announced a
consulting service specifically for contract
manufacturers and packagers in September.
Wh i l e Tr a ce L i n k i s exc l u s ive l y a
multitenant system, most of the other
t r aceabilit y IT vendors offer either
on-premise or cloud-based single-tenant
TraceLink maintains that a multitenant
system (where any software upgrade affects
all users more or less at that same time)

provides a better guarantee of interoperability
and lower cost of ownership, because
the exercise of reconfiguring the software
is avoided. Its competitors, however, argue
that a single-tenant version has a higher level
of security for individual customer's data
and more control over access to that data.
Arguments on both sides of this question
are compelling, although the growing use
of TraceLink's solution is pointing in the
multitenant direction. To some degree,
SAP is straddling the tenancy question by
developing a platform, PharmaNET, that will
offer trading partners a means of exchanging
information speedily.
Haris Kamal, SVP at Verify Brand, makes
the point that multitenant solutions reduce
the user's configuration control, and create
complications when that user wants to
customize the platform for specific needs.
And while mutitenancy and interoperable
industry standards like EPCIS are supposed
to make exchanging information relatively
straightforward, the reality is that many
traceability implementations have custom
modifications of one sort or another. This
variability might dissipate as more systems
are deployed and as EPCIS, Open-SCS and
governmental guidances become more
established; that's a question the industry will
be resolving for years to come.
Downstream traceability
The full implementation of DSCSA will
require the active participation of retail
pharmacy and hospital-based health systems,
who are obligated to verify the authenticity of

Group, have been similarly recommended by
Premier, Inc., a leading GPO.
One company that might have a beeline
into retail pharmacy DSCSA compliance
is ValueCentric, which has been collecting
and analyzing distribution data, based on
conventional EDI records, for years for
pharma and distributor clients. The company
claims a DSCSA compliance capability that
will meet pharmacies' coming deadlines, and
has worked closely with Walgreens in the past
on data collection and reporting.
Blockchain curiosity
Another traceability theme that has
arisen during 2016 is the applicability of
blockchain technology to pharma traceability.
Blockchain, also known as distributed
ledger technology (DLT) is the underlying
technology for bitcoin, the currency not
based on any national treasury. At its heart,
blockchain is a method of distributing the
validation of a record or transaction across
many data-storage systems, none of which
are connected directly to another. In effect,
the network itself is the validation of a record.
For pharma traceability, blockchain could
do two things: relieve the dependency of one
centralized data repository where all records
would be maintained (which is the driving
principle of the national authentication
systems under Europe's FMD); and, with
the appropriate data-access controls in place,
enable companies who are not direct trading
partners of each other to verify transactions
and, ultimately, drug authenticity. (It bears
mentioning here that the driving force

An inline barcoding unit from Servicepoint Oy. Credit: Servicepoint

the products they receive from distributors in
their own systems. The major wholesalers are
offering to do this as a service to their retail
pharmacy clients, especially the independent
pharmacies; but little is being heard from the
major drug chains.
On the health system front, however, 2016
saw significant progress by hospital pharmacy
directors eager to deploy traceability as a
means of managing their internal flow of
drug products. Here, TraceLink has racked
up several clients, including some major
group purchasing organizations who, in turn,
recommend TraceLink to their members.
RfXcel and a new company, The Forerunner

for passage of DSCSA was to prevent the
distribution of counterfeit products, and
FDA is most focused on protecting the US
supply chain from those counterfeits.)
FDA has left open how DSCSA data is
to be communicated up and down the
supply chain when the system is fully
established after 2023. A central repository
is conceivable (although who would run it
is an open question); another is a so-called
federated system of repositories that could
communicate with each other. (At the
moment, each originator of package serial
numbers is keeping its own data stored, and
continued on page 23

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Table of Contents for the Digital Edition of Pharmaceutical Commerce - November/December 2016

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Pharmaceutical Commerce - November/December 2016 - Table of Contents
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Pharmaceutical Commerce - November/December 2016 - Cover4