epcis - TraceLink

EPCIS:
The Standards, Supply Chain
Implications, and Solution
Provider Expertise
Introduction
The Electronic Product Code Information System (EPCIS) is playing an
increasingly pivotal role in the life sciences supply chain: the EPCIS
information standard is a candidate to meet compliance requirements
in several markets; and more companies are beginning to rely on EPCIS
for internal serialized data communications between levels of their
organizations. For supply chain companies operating in today’s complex
and regulated environment, being able to utilize and interoperate with
EPCIS is becoming a critical part of doing business.
TraceLink executives have been integrally involved with the development
of EPCIS guidelines for use within life sciences, providing regulatory and
technical expertise in four EPCIS-related GS1 working groups. There is
currently no EPCIS certification that is relevant to life sciences guidelines but
a DSCSA-applicable one is expected in 2015, and TraceLink will complete
certification upon its release.
The TraceLink solution supports the use of EPCIS between internal systems
and trade partners at the packaging line, enterprise, and network levels,
offering flexible integration and data translation and transport capabilities.
TraceLink’s network solution allows customers to seamlessly exchange data
between both their own systems and with trade partners regardless of
format discrepancies or differing transport preferences, allowing them to
seamlessly achieve both business efficiencies and partner interoperability.
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EPCIS Information and Interface Standards
The Electronic Product Code Information System (EPCIS) was
developed by GS1 to enable event exchange between systems
and trade partners. It is industry-agnostic, and currently used to
capture and exchange serial numbers in apparel, equipment,
electronic, and food industries, among others.
EPCIS specifies two standards: information and interface. The
information standard informs the format and content of how
information is exchanged between companies and systems, while
the interface standard specifies the method of data interchange,
or how information moves between systems and companies.
Overall, the two standards dictate structure and method.
Information standard
The information standard provides the what, where, why, and
when about serialized events through an xml schema and a core
business vocabulary. The xml schema defines the structure for
communicating different kinds of serialized events, such as
object, aggregation, and transformation. The business vocabulary provides a standard nomenclature for how to express the
types of events that are occurring in business steps and
disposition. What was the business process in which the event
occurred? It helps convey all key functions that happen in your
warehouse and across your supply chain. The vocabulary also
gives you a business transaction type that you may want to
reference, such as a purchase order or invoice number, and
source and destination types. It provides a way to include data
that is part of your event, like the ‘from’ and ‘to’ parties in
shipping events.
FORMATS:
PML, XML,
Extended
EPCIS
FORMATS:
XML,
Extended
EPCIS
TRANSPORTS:
SFTP, AS2,
SOAP, Manual
Upload, HTTP
Post
TRANSPORTS:
SFTP, AS2,
SOAP, Manual
Upload, HTTP
Post or Java
.API or Net
.API over REST
Packaging
Line
ERP/WMS
US
Packaging
Line
ERP/WMS
EMEA
Packaging
Line
ERP/WMS
S. AMERICA
Packaging
Line
Packaging
APAC
Overall, the information standard provides a common framework
for trade partners to interoperate and understand what each
piece of information means. It enables integration of operations
between both partners and systems.
Interface standard
The interface standard defines capture and query, the mechanisms by which information is either input or sent between
systems, and then requested from them. There are specific
choreography and transmission methods for both.
EPCIS and Supply Chain Regulations
Although EPCIS event exchange is occurring amongst some Life
Sciences companies, the EPCIS capture and query mechanisms
are not generally being leveraged by the industry to meet compliance requirements. Because businesses already have established
ways of moving data between each other and established
infrastructures (AS2 and FTP), there has not been a movement
to introduce EPCIS as an interface standard. The information
standard, however, is being considered by both the United States
and Brazil. In the United States, some early adopters have begun
to exchange EPCIS events using existing B2B infrastructures.
Because the defined GS1 standard is industry-agnostic, GS1
typically appoints industry-specific working groups to address
particular needs when the standard is under consideration to
address regulatory requirements. Within Life Sciences, there is a
public policy working group that tracks all regulations and a
technical working group that focuses on the law and considers
how the industry might leverage EPCIS to meet its requirements.
FORMATS:
XML, Extended EPCIS,
EDI 856 ASN
TraceLink-supported Formats &
Transports at the Packaging Line,
Enterprise, and Network Levels
Tracelink
Customer
serialization
event repository
TRANSPORTS:
FTP, AS2, SOAP,
Manual Upload, Web
Portal, HTTP Post
Trade Partner
Government
Trade Partner
Government
Trade Partner
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The technical group looks at the details of the law against the
standard, including what additional fields would need to be
incorporated and how and when the law requires this data
to be exchanged.
In the U.S.
The GS1 US Healthcare working group, Rx Secure Supply
Chain, looked at DSCSA requirements and different use cases.
Since DSCSA requires an interoperable data exchange format,
they considered how to use EPCIS extension points to insert
required data fields. They created Implementation Guideline:
Applying GS1 Standards to US Pharmaceutical Supply Chain
Business Processes for the Drug Supply Chain Security Act and
Traceability. This guideline specifically details all extension fields
and when they would be used to meet the requirements of the
law. The working group then provided the guideline to industry to
illustrate what sending and receiving data via EPCIS would look
like, and how they might meet DSCSA serialization requirements
and allow companies to interoperate. The guideline is very focused
on data formats and does not prescribe how the data is exchanged.
TraceLink played a critical role in helping to define this GS1
Healthcare US guideline, contributing use cases, providing an
understanding of how the law works, and helping to draft the xml
schema. TraceLink has also commercially deployed this
standard, processing nearly 70,000 EPCIS shipment transactions – each with commission, aggregation, and shipping event
data – in a 30 month period.
In Brazil
A similar process is currently underway in Brazil, and TraceLink
is playing a very active role as part of the Health Subcommittee
for GS1 Brazil. There are just two document authors for Brazilian
Medicine Traceability using GS1 EPCIS, the Brazil guideline: a
GS1 representative, and a TraceLink representative who is
serving as the technical editor. TraceLink developed and
documented the xml schema and is also playing a key role in
defining the EPCIS extensions for all event types to meet RDC
54 requirements. The Brazil law requires that all events – shipments, receipts, returns, destruction of product, and more – are
exchanged between supply chain partners and then submitted
back to a central repository. Lastly, TraceLink will also be
providing support for the mid-2015 Phase 1 process.
EPCIS for Internal Serialized
Data Communications
For some companies, EPCIS is the preferred standard for
internal communication of serialization data at multiple levels
throughout their organization, typically using the information
standard. TraceLink enables customers to use EPCIS in
this capacity.
Packaging Line Level
Some companies have adopted EPCIS as their data format to
exchange commissioning and aggregation data between the
packaging line level where the work is done and the serialization
numbers are applied, and the solution that captures it all. EPCIS
acts as the data formatting protocol between those two
systems, addressing what the message looks like.
Some packaging lines began building in serialization mechanisms prior to the advent of EPCIS, but those systems will still
need to be able to communicate and interact with the EPCIS
format. The TraceLink Life Sciences Cloud includes a data
translation layer that converts data it receives in any format
into a canonical one, neutralizing system disparities.
For instance, TraceLink will receive commissioning and
aggregation data from the Optel packaging line system using
EPCIS but may translate that for data exchange with a trade
partner. It may be translated into a non-EPCIS format such as
Product Markup Language (PML), or into a trade partner EPCIS
format. Even if a trade partner is using EPCIS, it’s highly likely
that they will have customized it with their own extensions, so
some degree of translation still needs to occur and can be
managed by TraceLink’s solution.
Enterprise Level
At the enterprise level, it’s rare to find an ERP or warehouse
system that speaks EPCIS: most of them pre-date the concept
of both serialization and EPCIS. Either they do not support
EPCIS at all, or companies – who rely heavily on the stability of
these core business solutions – are not willing to upgrade to the
latest version. Yet these systems will still need to communicate
with the mobility and other devices that are used in the warehouse to collect and communicate serialization data.
That’s why flexible integration is so important. The TraceLink
approach minimizes disruption and the need for change to these
systems by being able to work with all data formats and provide
an interface between systems. TraceLink provides SOAP, Java,
and .net APIs to receive serialization event data – pack and
unpack operation, decommissioning of serial numbers, and
more - from warehouse mobility devices. This provides flexibility
to solution providers, giving them three integration options for
communicating data back to TraceLink from their warehouse
scanning applications.
Overall, supply chain companies are using countless different
systems and languages, including EPCIS. TraceLink can convert
between all of them – going from EPCIS to PML, or .csv to EPCIS
– providing data translation regardless of the specific format.
Network Level
At the network level, supply chain businesses need to communicate
what they are shipping and receiving with their trade partners,
who will typically have their own serialization management
systems. This is where EPCIS comes into play as a highly
valuable tool around the U.S. and Brazil requirement that trade
partners exchange data.
When a manufacturer sends goods, they will also send
information about the associated serialization numbers and
aggregation hierarchies. This is new information that needs to be
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exchanged that hasn’t been part of supply chain communications to date in the US and Brazil, and presents an opportunity
for all parties to cleanly implement a standard to communicate
this data to potentially large numbers of supply chain trade
partners in a common way.
One good use case for EPCIS on the network level is between
manufacturers and their third party logistics providers (3PLs).
When 3PLs have to handle serialized product, manufacturers
need to be able to provide the serialized data to them so 3PLs
have what they need to execute and then communicate back to
the manufacturers. EPCIS works very well in scenarios like this,
where one business is operating on behalf of the other and both
can benefit from a standardized data exchange.
The complexity of supply chain data exchange is particularly
magnified in Brazil, where businesses have to exchange
compliance data not just with direct trading partners, but also
with indirect ones. Having a standardized format is extremely
important, especially when compliance is at stake. This is why
EPCIS is such an attractive option to meet this need.
While the EPCIS information standard would provide the
structure and standard nomenclature to allow interoperability in
these scenarios, it does not address the complex challenge of
transporting the data from one system to the next. How will
partners connect to each other and once connected, what
mechanism will they use to transfer the EPCIS messages?
The TraceLink Life Sciences Cloud provides a network platform
that eliminates the need to establish point-to-point connections
with dozens to hundreds or even thousands of trade partners. In
addition to reducing connection complexity, TraceLink’s network
accommodates all of the different ways that businesses will want
to transfer messages – SOAP, AS2, and many more. TraceLink’s
solution neutralizes the complexity of getting the data from one
point to the next.
EPCIS Certifications
When a solution provider becomes certified for the EPCIS
standard, they are getting certified against the global agnostic
one. This certification has no relevance in a regulatory compliance
context, and is not at all indicative of a provider’s ability to help
meet the compliance requirements at hand.
If you are using EPCIS for regulatory compliance, then certification
around the specific regulatory guideline is what matters. The
GS1, industry-specific working groups described above
establish certification or conformance test programs that take
into consideration all the extensions and use cases necessary
to meet compliance requirements.
What is the status of certifications for Life Sciences regulations?
By the time GS1 released their 1.1 guideline that focused on
DSCSA lot level compliance, the industry had already moved
ahead with the HDMA guideline for EDI ASNs. Right now, there
is no EPCIS certification available that is relevant to helping the
Life Sciences industry meet compliance requirements. Past
certifications that solution providers have do not enhance their
ability to provide solutions.
There is still more work to be done on revamping the guideline
around serialization before conformance tests are available, but
these tests and a DSCSA-relevant certification are anticipated
before the end of the year. When they are, TraceLink will
participate and will be certified to the EPCIS standard that is
relevant to Life Sciences by the end of 2015.
Conclusion
TraceLink has dedicated senior, strategic personnel to EPCIS
standard definition and actual implementation in the supply
chain. The company actively and regularly contributes regulatory
and technical expertise to GS1 EPCIS-related working groups,
participating in four. The first two concern the global standard,
and are country and regulation-agnostic: the GSMP EPC
Information Service 1.1 and Core Business Vocabulary working
group; and the GSMP Event-Based Traceability working group.
The other two are focused on applying the EPCIS standard
to country-specific regulations: the Rx Secure Supply Chain
workgroup in the US; and the Health Subcommittee for
GS1 Brazil.
While TraceLink’s active involvement benefits these working
groups and the larger industry, it also has significant influence on
the development of TraceLink solutions. Playing a leadership role
in EPCIS guideline development allows TraceLink to architect
products that take full advantage of EPCIS strengths; provide
guidance to customers around use of the standard; and
generally help lead the industry towards the next phase of
regulatory compliance.
Because the evolution towards global, industry-wide adoption of
EPCIS will be a long journey – and one which some companies
and systems may never complete – it is critical to have a platform
that can work with systems that contribute data in other formats.
The TraceLink solution acts as the link between internal systems
and trade partners, capturing event data and providing it with
both EPCIS and non-EPCIS formats, delivering interoperability.
TraceLink works with EPCIS when and where it has been
adopted, but can also do full serialization event capture,
management, conversion, and exchange with non-EPCIS
formats. This comprehensive solution insures that customers do
not need to write additional code in order to receive data from
trade partners who do not have EPCIS, or to accommodate
government reporting format requirements. Ultimately, TraceLink
customers can seamlessly exchange and manage data in a
multi-format world, achieving interoperability regardless of
diverse requirements and system and partner capabilities.
The material set forth herein is informational in nature, subject to change
without notice, confidential and proprietary information of TraceLink and
does not constitute a representation or warranty of TraceLink.