TrackTrace Rx

Month: February 2015

How to Handle DSCSA Exceptions: Your Next Nuisance

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Pharmaceutical manufacturers, whole sale distributors, dispensers and re-packagers that constitute the United States drug supply chain are busy these days in a thorough restructuring around their core operations. The restructuring is part of country-wide preparations aimed at achieving total compliance with the guidelines for transaction data exchange laid down in the recently passed US Drug Supply Chain Security Act.

The involved companies are expected to establish mechanisms that track and trace Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) for every shipment. The instated mechanism must have provisions to integrate generation, transmission, confirmation, storage and retrieval of the documentation associated with the exchange, and needs to be in place before the FDA’s deadline of 1st May, 2015. That’s a whole lot of work, and a number of companies are pumping in all resources at their disposal to get done with it, hoping that the intricate transaction data exchange would work like a charm from 1st May onwards.

There’s a catch though – too much of a broad focus on the exchange mechanism might result in companies overlooking an important underlying decision: how to handle exceptions. An exception handling process gone bad is all that it takes to bring your track-and-trace mechanism to a halt.

So, what exactly is an exception, anyway and why should companies care? It turns out that an exception refers to an honest mistake (rather than an intentional malice) during a shipment. Companies makes such mistakes frequently – especially distributors generating exceptions is a commonplace occurring.

An exception can manifest itself in the medical supply chain in either one of the following three ways:

  1. As a drug present on both the packing list and in the DSCSA transaction exchange data that has mysteriously gone missing from the physical shipment.
  2. As a package present in the physical shipment nowhere to be found in the DSCSA transaction exchange data.
  3. The transaction data delivered to the intended destination but the shipment itself delivered to a wrong location.

That said, exceptions are a novel occurrence by no means. Exceptions in the drug supply chain exist since ever. Traditionally, companies had a number of ways of handling and correcting exceptions including return of the extra product, re-shipment of the missing product, additional billing in case of surplus shipment, etc. Most of these quick fixes ensured the customer was not being overcharged in case of an exception. Upon due satisfaction exhibited by both the selling and the buying parties, an exception was mutually agreed upon as being handled. In essence, the process of exception handling was not standardized and varied across different companies at a transactional level. All that was needed was the involved parties agreeing upon a fair solution to the then prevalent situation.

Times have changed now. Once companies have established data exchange mechanisms that enable conformity to the DSCSA guidelines, exception handling is going to become a system-wide headache if not addressed properly.

Consider the example of a wrong product in a shipment sent out to a pharmacy. The TI and TH in this case would exhibit a mismatch when stacked against the products received. The pharmacy would be stuck with a drug it didn’t order in the first place and missing on an important drug that was originally ordered. Handling this simple exception is not going to be as easy as it was prior to the introduction of the DSCSA. Why? Because both TI and TH will need to be corrected at the end of multiple trading partners involved in the supply chain. This, in turn, would most likely require reopening the electronic data exchange, advance shipment notice and performing associated edits. The same would need to be done with the transaction data maintained by all trading partners involved – way easier said than it’s actually done.

And now the good news. We’ve painstakingly incorporated exception handling capabilities in our state-of the-art, cloud-based server, making compliance with transaction data exchange requirements laid down in the DSCSA ridiculously simple. Here are some examples on how we handle this:

1. Most of the EDI solutions out there won’t allow you to search and correct your old ASN’s. The TrackTraceRx EDI capabilities will allow your organization to correct any previously received ASN’s.

2. Correcting outbound T3s can be a challenge. One of the challenges is to make changes and work with downstream trading partners to apply the necessary corrections. In a scenario where an outbound T3 was sent, having communication with a downstream trading partner is essential in making these changes in a corporative manner. TrackTraceRx streamlines this process so when changes are made, the entire supply chain is aware and onboard with the needed corrections.

3. When handling exceptions, it’s important to keep a trail of the original T3 and what was changed in case an audit verification is requested. Showing proof of your previous changes are a must. Our logging capabilities excels all other solutions by time stamping every change that is done within the system and by whom.

Feel free to drop us a line and discover how we can help you with exception handling in particular, and DSCSA compliance in general.

Choose the Right ERP System to Meet DSCSA Compliance

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In this article we will discuss how to choose the right ERP system that can work with an external DSCSA solution provider. This integrated solution in passing transactional data (T3s) per the DSCSA requirement is really important in order to be fully automated with your supply chain to save on a lot of manual work.

First let’s go over what an ERP is:

A Enterprise Resource Planning (ERP) is a business management software that manages your business core data related to different activities such as:

Product planning – Cost
Marketing and Sales
Inventory Management
Shipping and Payment

Someone asked me once, “If i have an ERP, why do I need to select a DSCSA Solution Provider? Couldn’t my ERP system handle everything required under the DSCSA”.

The answer is, “probably not”. The reason being is that an ERP system is optimized to manage the core functionality of your business. Managing the requirements of the DSCSA is very complex, (see: Understanding the DSCSA). A good DSCSA solutions provider will be versatile enough to talk to multiple trading partners, communicate with the FDA, perform audit logging, correct traceability errors, and add business continuity to your data. An ERP system is not really built to handle this efficiently. An example is, even though an ERP provides good Inventory Management, it can never be as efficient as a Warehouse Management System (WMS).

So which ERP system should I select? Well it depends, a few popular ERP systems available on the market are:

SAP Business One
QuickBooks Enterprise
Microsoft Dynamics

Each one of these solutions have their pros and their cons. What is important is that before you start your search for the right ERP, it is important that you come up with an ERP system selection methodology. This is a formal process for selecting an ERP system.

Primarily, try to match an ERP system based on what your business requirements are. There are some ERP systems that are more geared for manufacturing and have lack  of customer relationship management and e-commerce. Selecting the right one depends on your needs. Most ERPs have additional add-ons you might need to purchase, so doing your  research beforehand will help in selecting the right ERP for your needs.

There needs to be full involvement by all personnel within the organization. This decision must be made by all stakeholders within the organization, especially by the leadership team. All stakeholders must participate in gathering requirements and attending vendor demonstrations.

90% of implementations are either late or over budget. Most of the time this happens when an organization did not fully understand what the vendor offering was. An example, when it comes to data migration, most organizations don’t realize that to transfer data from one system to another, requires that the data to be exported, cleaned, and put it into a file format easily read by the new system. To have a successful migration requires a high level of data integrity; example: (bill of materials, formulas, recipes, routings etc). are usually needed to be far higher then what most companies have ever achieved. This is a typical challenge that causes delays on implementation and increase in cost.

A Possible Scenario

In your supply chain, what happens when you receive the same products from different vendors but with the same lot numbers? A solution for this, is to have your ERP system use the same lot numbers but add a period followed by a specific serial number that will be related to their respective trading partners. example:


Make sure your ERP system can handle this type of scenario and also your DSCSA solution provider.

Integrating with a DSCSA Solution provider

Once the new ERP system is installed and the data is intact, your next phase will be integrating with a DSCSA solution provider. The biggest challenge is defining the business of process of what needs to be achieved to fully automate the data coming from the ERP and  communicating what is necessary in creating your T3s. It is important that your DSCSA solution provider can handle receiving shipment data and outgoing shipment data. The TrackTraceRx manages this data by associating receiving shipment data and tying its inventory to a  “inbound state” and your outgoing shipment data by a “outbound state”.

Here are a few scenarios of what needs to be done to receive an inbound T3:

1. An ASN, (Advanced Shipment Notice) will be received via EDI from your upstream trading partner which will generate a T3 on your DSCSA solution provider. Doing it this way will not require your organization to manage a EDI/AS2 server or work with a outside VAN to manage this. A VAN is a Value-added Network external company that can manage your EDI services for you. Make sure your DSCSA solution provider can support handling EDI. In this scenario, all of your costs will be incurred using your DSCSA solution who handles everything.

2. A second scenario is having your ERP system to support EDI via an external VAN company. Once this data is received, you will communicate this data to your DSCSA solution provider to generate an inbound T3. You will incur the cost from your external VAN company and possibly your ERP vendor as they are handling your EDI documents. You will also incur cost from your DSCSA solution provider as they will be managing your T3s. The biggest challenge by not letting your DSCSA provider handle your EDI documents for you is that you will need to make sure that your external VAN company will be able to make changes to your ASNs in case there are errors with your shipments. Also, make sure that your external VAN company re-certifies their EDI server on a yearly basis as some trading partners only integrates with companies that are certified.

3. The purchase order (PO) you generate to your vendor may have the necessary data to create your T3s. But this scenario is only possible if you have a rock solid agreement with your trading partner to send you the correct information. In the real world, most likely your trading partner will never send you exactly what the purchase order shows. Most companies will probably not use their purchase orders to generate T3s.

Now for the Outbound Process:  This happens when you are ready to ship your product.

Depending on what your business process looks like will determine when the right data is sent to your external DSCSA solution provider. This could be when you generate your invoice or generate your packing slip. Most likely the data will be correct when you generate your packing slip. Once the packing slip is generated, this data needs to be passed to your DSCSA solution provider. With this data sent, your DSCSA solution provider will then be able to generate a outbound T3 for your records.

All and all selecting the best ERP system takes a lot of work, teamwork, and support from your organizations leadership team. The most important aspect of selecting the best one is carefully evaluating all of your business requirements necessary from start to finish.