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Are You Ready for DSCSA/DQSA and Other
Global Regulations?
5 steps to implementing a successful traceability and interoperability strategy for your
pharmaceutical or medical device supply chain
The right traceability solution will both
ensure compliance and deliver long-term
benefits such as efficiency, cost savings,
and track-and-trace capabilities for
anti-counterfeiting, recall management
and other critical processes.
Stringent regulations for pharmaceuticals and medical devices (including U.S.
DSCSA/DQSA, Brazil Anvisa RDC-54, India DGFT, China SFDA DMF, EU FMD and U.S.
FDAMA) require organizations to track product movement from the manufacturer to
the pharmacy, and trace financial and physical chains of custody from the pharmacy
back to the manufacturer.
To ensure global regulatory compliance in the coming months and years, IT leaders
throughout the pharmaceutical and medical device supply chain must act now.
2015 Global Regulatory Deadlines
April 2015
May 2015
December 2015
India’s DGFT Public Notice No.
The United States Drug
Brazil’s National Health
21 requires GS1-compliant
Supply Chain Security
Surveillance Agency,
barcode serialization for all
Act (DSCSA) — Title II
(ANVISA) RDC 54 resolution
exported pharmaceuticals,
of the DQSA requires
requires pharmaceutical
including primary, secondary
manufacturers, re-packagers,
manufacturers, wholesale
and tertiary packaging labels
and wholesalers to be able
distributors, re-packagers
to securely exchange
and dispensers to provide
electronic or paper-based
serialization and tracking data
lot-level transaction
for three batches of products
information (TI), histories
(TH), and statements (TS)
for all shipments
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Here are 5 steps to establishing a compliance
strategy for DSCSA/DQSA and other upcoming
chain-of-custody and track-and-trace regulations.
1. D
ecide how you will exchange information
with trading partners
You have several options:
Paper documents: A paper document minimally impacts existing systems and
processes, since it’s usually just a modified packing slip. But paper-based data
exchange is error prone and expensive — cost pressures alone often push
companies to shun paper in favor of electronic data exchange. In addition, not all
global regulations allow for paper in the supply chain, and DQSA allows for paper
only until November 2017.
Even if you choose to eliminate paper on your end, you will need to accommodate
trading partners that are low-tech and even no-tech (like small pharmacies and
healthcare providers serving specific neighborhoods), with little to no EDI or B2B
infrastructure. Consider providing a portal where these partners can download
and print transaction information (TI) for their records.
Modified ASN: Not to be confused with Rx ASN, which doesn’t address lot-level
traceability, modified ASN is a version of ANSI x12 ASN 856 and the method
recommended by the Healthcare Distribution Management Association (HDMA),
a group comprised of the industry’s major wholesalers.
If you are a manufacturer selling to authorized distributors of record, modified
ASN will work well because you don’t need to pass transaction histories (TH), you
already have EDI, and you are already doing ASNs. You just need to migrate to the
new format.
But if you do have to pass TH, be sure to address the issue of master data
replication. Start by answering these questions:
• Will you repeat the data in the ASN every time you pass it forward?
• What’s your migration path as you move from lot-level traceability
requirements in 2015 to item-level serialization in 2017?
• How would you support aggregation and inference in global markets if you
ever needed to?
• Who will maintain this standard in the future?
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EPCIS 1.1: Ratified by GS1 in June 2014, EPCIS 1.1 aligns with DSCSA/DQSA. The
GS1 U.S. Healthcare Implementation Guide provides guidance on implementing
lot-level traceability using EPCIS transactions. If you’re considering it, ask yourself
the ASN questions above, as well as how an EPCIS solution will align with your
overall strategy to address current and emerging global requirements.
Note: U.S. FDA Interoperability Guidance released in 2014 didn’t specifically
endorse any one of the communication standards above, but endorsed all three.
So even though you now have some latitude when communicating transaction data,
your best bet is to support all three options.
2. A
rchitect an information model and data
exchange standard for transaction information
(TI), transaction histories (TH), and transaction
statements (TS)
Do you have a single information system for all TI, TH and TS? Probably not, especially
if you use third-party logistics providers. Now is the time to re-evaluate (and perhaps
re-architect) your data collection and retention strategy, so you will be able to store,
index and search all data for all shipments in a single interoperability format.
First, create an information model of your supply chain that can capture the
entities and authoritatively identify the source of those entities and their owners.
Next, architects must ensure they can identify the interface available to access
these entities. This is key to a quick implementation of the data exchange standard,
since the architects will be aware of what data they have and where it is located.
Distributors will need a mature platform that can integrate disparate sources of
data and translate them into the required format. This is the only way to quickly
implement the data exchange standard with reliability and agility.
You’ll eventually need a repository that will serve as your data store to house all of
this transaction information — a key function of a compliant track-and-trace system.
3. M
ake sure you can respond to a regulator’s
request for information (RFI) in as little as
24 hours
How long does it currently take you to verify a product’s lot number, expiration
date and whether you actually manufactured it? Odds are, it takes you longer than
DSCSA/DQSA and other regulations will allow.
To promptly respond to RFIs, recall certain batches from the market, and quickly
track where your products were sent, you’ll need a searchable transaction repository
that provides out-of-the-box reporting. This will enable you to quickly and easily
generate a lifecycle view of a particular batch on demand.
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When building an EPCIS event repository,
You can go a step further by providing a real-time verification portal that lets your
partners research and verify exchange transactions themselves, and gives you the
visibility to audit all activity.
you must first collect the master data to
initialize your system, and then collect
events from your product line, your
warehouse system and your partners.
In doing so, you are almost certain to
encounter many disparate formats and
protocols across a range of applications.
Vendors that provide powerful
capabilities for integrating all types
of flows into the event repository will
4. P
lan a migration path from lot-level traceability
to item-level serialization
Rx counterfeiting may be a minor problem in the U.S. today, but it’s a major problem
abroad. So, while item-level serialization is the long-term goal of DSCSA/DQSA, it’s a
near-term focus for compliance laws around the globe.
Obviously, you don’t want to be forced to change your traceability and integration
implementation again in a few years, so plan now for the item-level serialization
mandates that are on the horizon. You should look for a solution that:
differentiate themselves in the market.
Ensures the uniqueness of serial numbers (barcode or RFID) at the pallet, case,
and/or unit level across multiple lines or facilities/plants
Supports multiple serial number formats, including GTIN and SSCC
Integrates with line management systems or off-line labeling systems
5. Align
with global standards, including
GS1 EPCIS
Years ago, the life sciences industry’s leading manufacturers and distributors
asked the GS1 consortium to create standards that would facilitate the exchange
of transaction data throughout the global pharmaceutical and medical device supply
chains. Today, GS1 EPC Information Services (EPCIS) is the de facto data exchange
standard for ensuring interoperability between technologies and entities across
the globe.
GS1 recently published version 1.1 of the Implementation Guideline1 for the
serialization and traceability capabilities required to comply with DSCSA. It is
important to follow this guideline by basing your interoperable data exchange
strategy on a solution that is fully certified by GS1 to be EPCIS compliant. You can
also leverage EPCIS to detect diversion, parallel trade and forward buying.
It’s not too late, but the time to act is now
The 2015 global compliance deadlines are rapidly approaching, but it’s not too late
to devise a strategy to meet them. While there will be some initial “pain” associated
with implementing the new traceability and interoperability capabilities required
1 http://online.wsj.com/articles/tim-cook-says-apple-to-add-security-alerts-for-icloud-users-1409880977
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by DSCSA/DQSA and other regulations, the “gain” will make it all worthwhile. For
example, in addition to achieving regulatory compliance and improving patient safety
in the near-term, your traceability solution will deliver long-term benefits in the form
of efficiency, cost savings and track-and-trace capabilities for anti-counterfeiting,
recall management and other critical processes.
Many factors will come into play as you evaluate potential solutions, including your
organization’s operational maturity and IT capabilities, and the specific country
or regional regulatory requirements you need to meet now and in the future. The
deployment model you choose (such as on-premise software or a cloud-based SaaS
solution) will affect your costs and return on investment.
Once you have defined and successfully implemented your strategy for global
regulatory compliance, your organization will be able to:
Integrate with your external trading partners, including government agencies, contract
manufacturing organizations, downstream supply chain partners and customers
Track items across the entire supply chain in real time, manage distribution
efficiently and gain visibility
Reduce recall costs by tracing product contamination back to affected batches
Track the financial chain-of-custody across the supply chain
Respond to inquiries from authorities, partners and customers about the warranty,
recall, destruction status and proof-of-ownership of a product
Optimize business processes to combat counterfeiting and effectively manage
product recalls involving hundreds of millions of serialized products
Update Electronic Health Records (EHRs) with traceability information, including
caregiver identification
Detect counterfeit products entering the legitimate supply chain
Axway can help.
Throughout the global supply chain, the top 20 pharmaceutical manufacturers,
the major U.S. healthcare wholesalers and distributors, and leading U.S. retail
drugstores rely on Axway 5 Suite for Life Sciences to reduce the cost and complexity
of compliance. What’s more, the regulators themselves, including the U.S. FDA, use
Axway 5 Suite to help manage their global traceability initiatives.
Axway Track & Trace
The winner of multiple iBusiness awards, Axway Track & Trace is the heart of Axway
5 Suite for Life Sciences. It has evolved from a scalable EPCIS repository to a
policy-driven enterprise solution that is rich with features created from real-world
implementations and functional specifications.
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Axway Track & Trace combines a SOA-based architecture with more modern
integration technology to provide web services APIs for serial number management,
packaging hierarchy and inference support, product ID verification, and certified
EPCIS capture and query interfaces.
Axway Track & Trace provides flexible architecture options ranging from a central
global repository to a distributed network of regional repositories sharing data via
EPCIS standards, as well as flexible deployment options such as hosting in the cloud
or as a managed service.
Axway Track & Trace provides unit-level serialization, point-of-sale
verification and central government reporting.
Deploy on-premise or in the cloud to leverage your investment in
existing traceability infrastructure
Establish a global EPCIS-certified solution
Implement one centralized regulatory reporting infrastructure
Manage one security framework with a streamlined user experience
Maintain regional autonomy with flexible distribution
center integration
Centrally manage the generation and allocation of serial numbers in
range or randomized formats
Use the product’s secure, out-of-the-box portal to:
• Give contract manufacturers the ability to manually download serial
numbers or request them via a web services API
• Integrate your existing websites to the EPCIS repository
• Offer secure, instant product verification via the web and mobile devices
• Track external verification inquiries with reports and real-time alerts
Use the indexed and easily searchable repository to rapidly respond to
requests for information
For more information, visit www.axway.com
Copyright © Axway 2015. All rights reser ved.
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