Are You Ready for DSCSA/DQSA and Other Global Regulations?

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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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