TrackTrace Rx

Month: May 2015

How EDI Can Help Automate your DSCSA Communication

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What is EDI?

EDI stands for Electronic Data Interchange.

1. It’s the exchange of electronic file.

2. In a standard format that is easily processable by a computer.

3. This exchange can be automated without any human interventions.

EDI has been around since before the Internet. Back then communications between businesses was slow and prone to errors. Exchanges of invoices, shipping notices, purchase orders, and sales reports between different trading partners were sent via paper documents.

This was the 1960’s. As technology advanced, EDI evolved to allow businesses to communicate using paperless document transfers between different companies.

One thing to remember is that EDI is not dependent on technology. There are ways to implement EDI, but there are different approaches to choose from. These approaches needs to be driven by your business needs, and not by a particular technology.

Advantages of using EDI

1. Manage huge volumes of transactions

2. Less operating costs

3. Eliminate mailing delays

4. Eliminate human data entry errors.

Example of different Business Work Flow Scenerios that are improved when using EDI:

Buyer (customer) creates a purchase order (PO)
PO is sent to supplier via EDI
Supplier loads a Sales Order in response to the PO, with optional changes.
Supplier acknowledges PO (with any changes)
Buyer changes quantity of a line (part)
Buyer-initiated Change Request is sent to supplier via EDI
Supplier implements or rejects changes
Supplier sends summary of changes/rejects to buyer via EDI
Supplier needs to delete a line as they can no longer supply
Supplier sends supplier-initiated change request to buyer/customer via EDI
Buyer receives change request and implement or rejects changes
Supplier ships material
Supplier sends an Advance Ship Notice (shipping manifest) via EDI
Supplier sends invoice via EDI

There are a few components that you need to have to get EDI working on your environment.

1. Mapping Software – The mapping software retrieves data from your accounting software, ERP or WMS.

2. Translation Software – The translation software translates the data into an EDI format.

3. Network or VAN provider ( Value added Network Provider) – A VAN provider will securely transport your EDI data to and from your trading partner. Your Van provider will provide support and maintenance making sure the data is correctly being received and sent.

With the components in place, you are now able to apply your process to execute an EDI transaction. There are two processes for EDI. The outbound process and the inbound process.

The outbound process is when your mapping software generates the data out of your database. In the pharmaceutical world, this usually happens when a shipment is being prepared to be shipped.

Next, the EDI translator retrieves this mapped data and translates the data into an EDI file.

Let’s look on what a sample EDI file looks like:

ISA*00* *00* *13*2362340301 *12*6734245337 *150515*1537*U*00401*000000548*0*T*>~
GS*SH*9545843340T*8664307337*20156515*1537*2*X*004310~
ST*856*000000002~
BSN*00*103670343*20150515*153755~
HL*1**S~
TD1**1~
DTM*011*20350515~
N1*ST*COMPANY PHARMACEUTICAL LLC*11*RL0362347~
N3*EAST ADDRESS UNIT 5~
N4*MIAMI*FL*33126~
N1*SF*COMPANY PHARMACEUTICALS, INC.*23*GCFNP5N00~
N3*8333 ELM STREET~
N4*FREDDY BRANCH*MI*33454~
N1*SE*COMPANY*11*RA018333233~
N3*26515 ELM ROAD~
N4*ORLANDO*FL*32819~
N1*BY*COMPANY PHARMACEUTICAL*11*RL0362347~
N3*1343 EAST ELM RD~
N4*JACKSONVILLE*FL*32836~
YNQ**Y***This wholesale distributor, or a member of its affiliated group, purchased the product directly from the manufacturer, exclusive distributor, or repackager that purchased directly from the manufacturer.***99*DPS~
YNQ**Y***This wholesale distributor has complied with each applicable subsection of FDCA Sec. 581(27)(A)-(G).***99*TS~
HL*2*1*O~
PRF*77140multi***201515~
CTT*0~
SE*23*000000004~
GE*1*2~
IEA*1*000000548~

As you can see, the file is quite cryptic. Remember, this was created for a computer to process, not a human.

The EDI file is then sent to a trading partner via your VAN. The method of transfer can be many. Most commonly, this data is transported using an AS/2 server.

The inbound process is similar to the outbound, but instead inbound. The data when received to the trading partner gets translated to a readable format, which is then mapped into the receiving trading partners ERP or accounting system. A mapping and translation software is of course needed to accomplish this.

And that’s it! A full EDI communication from trading partner to trading partner exchange is complete.

Finally, we believe that EDI will play a big role with the DSCSA interchangeable requirements. Especially when serialization starts to become a reality in 2017. Please contact TrackTraceRX to find out how our EDI solution can improve your business productivity.

DSCSA Template to send to your Trading Partners

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A lot of our customers are asking us for a sample letter that they can send to their trading partners so they can access their TrackTraceRx portal to retrieve their transactional data (T3s).

We created a Word template that you can download and modify to fit your company message to your trading partners. Even if you are not a customer of ours, feel free to use this template.

Download the DSCSA Trading Partner Template Here: DSCSA Trading Partner Template.

Here is the template without formatting:

To Our Wholesale Trading Partners:

As [Company Name] prepares for the July 1, 2015 Drugs Quality and Security Act requirements, we are requesting that all trading partners utilize the following choices for the required transactional data (T3s):

Option 1: Paper Packing Slips

Option 2: Email Attachements PDF

Option 3: TrackTraceRx Web Portal

Option 4: EDI – Advanced Shipment Notifications (ASNs)

Cost:
By being a valued customer, there is no cost associated with using our portal.

TrackTraceRX Web Portal

To receive your TrackTraceRx Web Portal credentials please contact us at 1-800-345-5555 or support@company.com.

Once your credentials are received, please visit https://companyname.tracktracerx.com to login to with your credentials.

For customer support accessing and using the portal please refer to your user manual. If additional support is needed, please contact us at 1-800-345-5555 or support@company.com

Sincerely,

John Doe
Compliance Manager
Company Name

Results of a DSCSA US Pharma Traceability Survey

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The 1st May, 2015 deadline for securing compliance with the DSCSA data transaction exchange requirements has begun. Most recently, the results of 2015 US Pharma Traceability Survey carried out by RxTrace, an independent consultancy, were made public. The findings of the survey are an important step towards quantifying the overall industry progress towards serialization and DSCSA compliance. Here’s a wrap up of the most noteworthy findings from the survey.

The first significant finding from the survey indicates that majority of the companies believe they possess a thorough understanding of the transaction data-exchange requirements laid down by the FDA in the Drug Supply Chain Security Act. To be precise, around 77% of the respondents claim to have read enough or all of the DSCSA to know what their company needs to do to meet the compliance requirements. That still leaves behind around 23% of the participants who either still need to learn more or are totally unaware of the new Federal requirements that are all set to have an impact on how their companies operate.

The second important finding states that around 40% of the companies involved in the survey consider themselves adequately prepared for meeting the requirements laid down in the DSCSA. On the other hand, 24% of respondents represented companies that just may or would not be able to meet the transaction data exchange requirements within the stipulated timeframe.

Another important inference from the survey is the time period spent by companies in preparing for securing compliance with the DSCSA. A whopping 22% of the participants reported to have started working on securing compliance in the last six months, whereas 16% of the partakers said they’ve just started working or, worst, are yet to start preparing for the requirements of the DSCSA.

Yet another deduction from the survey is that manufacturers and packagers that are yet to add serialization capabilities have an impractical idea of the time it takes to cultivate and deploy the required compliance updates to their operations. Furthermore, around 35% of the respondents reported to have not begun on adding components necessary to serialize the drugs they manufacture or repackage.

As to what is it that has held companies from starting to work towards serialization:

lack of understanding of the FDA guidance,

being a newer company,

and expecting a further delay in the serialization deadline have been reported as the main reasons.

Also, only a small percentage of the respondents felt that only a small percentage of those calling the shots in their respective companies clearly understood the DSCSA and the relevant FDA guidelines.

The results paint a gloomy picture. There is an excess of technical challenges manufacturers, re-packagers and wholesalers are facing as they choose the best serialization solution for their companies. Remember, if you are a wholesaler or a dispenser, the serialization data will come from the manufacturer. It’s important to have a ready system in place that can easily receive this data and display it in a clear concise way to be optimized to meet your supply chain work flow. Delivering this feature solution might sure be difficult, but it is by no means impossible.

The Significance of Local Master Data as a Supply Chain Resource

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For several years, majority of companies constituting the US drug supply chain have been facing a serious problem. The problem has had a drastic effect on the way internal IT systems work. Interestingly, the same problem has never made its way to the public. That’s probably because it has little to do with the public side of the operations, and has a more pronounced impact on the way in-house IT procedures are carried out.

What exactly is this problem, anyway?

It is the poor quality of local master data. For those of you who are not at home with the term, master data signifies the core data that companies keep in their internal databases to describe: their trading partners including customers and suppliers, the contract particulars including terms and conditions, pricing, legal framework, authorization, the products including self-owned and third-party offerings, and other mission-critical information.

The trouble arises when companies mistakenly think master data is something that is not supposed to change that often (hence, the name ‘master’ data). In reality, things are quite the opposite – with volumetric operations and expansion efforts, particularly for big companies, important changes are required in the master data on a more frequent (or even daily) basis. Failure on the company’s part to update the master data traditionally lead to additional costs – costs that did not show up immediately but were incurred in the longer run.

Prior to last fall, the problems with the master data were solely the company’s own headache, and didn’t have much of an impact on the way trading partners carried out their operations.

But that is not the scenario anymore. With the Drug Supply Chain Security Act in place, majority of companies have begun exchanging transaction data based upon the specifics laid down by the Food and Drug Administration. The DSCSA requires that the transaction documents including Transaction Information (TI), the Transaction History (TH) and Transaction Statements (TS) be accurate and updated regularly. If the accuracy and updates are not up to the mark, the corresponding trade partner is prohibited by federal law to induct the product into its inventory. Such a situation also requires a costly corrective routine to be executed before the product can be rendered a saleable item again. It’s worth noting that corrective routines that are an outcome of the seller’s poorly managed master data must be executed by both the seller and the buyer. The supply chain operations are stalled till a quick-fix is worked out by the seller. Meanwhile, the buyer keeps on suffering costs that could have been avoided.

A closer look at the 3T’s and the master data reveals that the poor quality of the master data manifests itself in the Transaction Information (TI). With TI statements being exchanged between the seller and the buyer with each and every shipment, incorrectly populated TI data fields due to substandard seller master data are a definite problem.

The solution to the problem is to stop thinking of the master data as merely a local, internal entity. Instead, master data is to be viewed as a supply chain-wide resource, with all the companies that constitute the supply chain having a certain stake in it. That, in fact, is the exact philosophy behind the design of TrackTraceRx, the state-of the-art, cloud-based server for securing compliance with the data exchange requirements. TrackTraceRx ensures that the quality of the master data meets the standards laid down in the DSCSA by the FDA, and the updates to the master data are timely and accurate.

Remove the Human Error Factor

The TrackTraceRx work flow focuses on automation and logging each change from beginning to end. Using our Electronic Inbox feature sets up automated technology to take control. This supports ASN’s via EDI, EPCIS, etc. Enabling the Electronic Inbox feature, removes any potential human error to your workflow that could affect your master data. This of course, is counting that your trading partners all have the technological capabilities to send this data electronically. What happens when your trading partner is only sending this via a PDF or even paper? The TrackTraceRX has an easy to use work flow wizard.  This wizard guides you into importing your data with security checks that make sure that the information is correctly being crafted before being submitted. The end goal of course is to make sure your data is being input correctly, giving you the confidence that your master data will be correct and protected.