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Choose the Right ERP System to Meet DSCSA Compliance

Christian Souza

Enterprise Resource Planner (ERP)

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
Manufacturing
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
Sage
QuickBooks Enterprise
Fishbowl
NetSuite
Microsoft Dynamics
Oracle

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.

Planning to use DSCSA use cases in your ERP requires leadership involvement.

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:

Lot123.TRDPRTNR1
Lot123.TRDPRTNR2

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.

Out of the box solution.

We recently launched our new ERP system fully integrated with EDI, Chargebacks and Track & Trace. The TTRx ERP is the first real pharmaceutical cloud based ERP. The best part, everything is "fully" integrated. This will save you on high costs in integration. Imagine paying to integrate with your EDI provider or Traceability system? If you would like to know more about the TTRxERP visit our site here.

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.

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