Frequently Asked Questions
LSPediA’s Verifier® VRS manages more than just saleable returns. It’s an interoperable peer-to-peer messaging solution for all supply chain transactions related to the unique product identifier, including fraud prevention, investigation, and decommissioning. Clients will see significant ROI from increased supply chain efficiency, data visibility, and turnkey compliance under the DSCSA regulations. See our list of Frequently Asked Questions (FAQs) below:
By the end of November 2019, every distributor in the United States must be able to verify with the manufacturer any returned drugs from dispensers and other sources. Every manufacturer needs to be able to provide data for verification by its trading partners. Without that verification, those drugs cannot legally be resold. Close to 90 percent of all returned product can be resold. These saleable products account for 2 percent to 3 percent of revenue for the pharma industry and are worth a total of $11 billion per year.
In short, you won’t be able to do business, ship products or return items in the drug supply chain unless you’re part of the verification system. Using a Verification Router Service, or VRS, is emerging as the industry standard.
LSPediA started demonstrating a live, working version of OneScan®, our VRS solution, in early December 2018. Since then, we have successfully completed more than 50,000 product scans. Our customers have given us excellent feedback, which we have incorporated into our VRS to refine and expand its functions.
You could use EPCIS data, but it may not be available to you. LSPediA surveyed manufacturers in January and found that only 10 percent of them are willing to send EPCIS shipment data. If your suppliers happen to be in that small group, you’re not going to add any manufacturers, and you don’t mind setting up your own verification system from scratch, EPCIS might work for you.
Absolutely not! Our VRS solution is designed to work independently of your serialization solution. Our VRS connects to the appropriate repositories for verification, whether those are internal or external databases.
Our VRS is a dependent system that works with:
- TraceLink data repositories
- SAP ATTP data repositories
- RfXcel data repositories
- Axway data repositories
In fact, OneScan® is a turnkey, plug-and-play solution for your business. We haven’t found any systems operating today that don’t work with our VRS.
Absolutely. Our OneScan® works in any location.
Our VRS verifies the legitimacy of the products on your shelf, as well as any that you’ve purchased and returned. This solution also allows you to check your inventory for recalled products simply by scanning your stock.
Setting up and activating OneScan® takes only a few days. After that, we get you connected with your trading partners, which depends on how quickly they respond to your requests. Depending on the number of partners, implementation typically is completed in 4-6 weeks.
Our pricing is based on your number of named users. We include 5 users in the base tier of the VRS, then allow you to add new named users as you need. We charge annually for licensing the product, which includes all transactions, verifications, upgrades and support.
There is also a nominal initial charge to set the system up, establish partner connections, and handle other technical installation needs.
NO! All transactions and verifications are included in the annual software expense. You can do from 10 verifications to 1 million and your cost will not change.
$0. Unlike some other overly complex, fragile platforms being offered, LSPediA’s Verifier(R) users aren’t forced to pay for expensive, never-ending third-party contracts to constantly monitor, maintain and fix the technology. Our support staff, training, updates, and upgrades are included in your annual payment. That’s why OneScan® boasts the lowest total cost of ownership of any VRS solution offered today.
We’re happy to work with anyone in the pharma industry at any time. However, we have chosen to avoid dealing with those third-party consultants who have clear, proven conflicts of interest. Those conflicts can motivate them to recommend solutions where the consultants will provide expensive, ongoing maintenance and support services.
Decommissioning a damaged, rejected, recalled or otherwise questionable product with OneScan® is simple. Whenever you scan an item, there is a pull-down menu that allows you to change the status of that item simply by selecting a new status (Commissioned, Decommissioned, Quarantined, etc.)
When you scan an item under recall, OneScan® will display “Recalled” on the screen and that product identifier will be logged in the history. This is a great way for suppliers and dispensers to determine which products are under recall, so that they can be taken off the shelf.
Just as important is the fact that our VRS makes sure you have a verified record to show regulators and law enforcement that you responded appropriately.
You must report the suspect product to the FDA. OneScan® expands to include LSPediA’s Investigator® module, which includes a simple notification button that allows you to instantly file those reports. The built-in workflow prompts your workers to take the required actions and creates a detailed record to document your response.
LSPediA’s warehouse scan study, conducted in January, found that 31 percent of products already are serialized, and that 21 percent were readable with a GS 1 scanner.
Of course – OneScan® connects to any manufacturer. Connecting your network of trading partners typically takes two to four weeks, depending on how quickly they respond to our requests.
LSPediA uses the official Authorized Distributors of Record maintained by the Food & Drug Administration.
A named user is a person that is using or accessing your VRS system. Typically, each admin and scan technician would be listed as a named user. That makes it easy to track transactions and report specific user interactions with the system.
A connection is made through a lookup directory to the appropriate provider, then the verification is confirmed.
OneScan® provides a history that displays all transaction and verification details for you to check at any time.
Yes, it does. Under the DSCSA rules, manufacturers are responsible for responding to a verification request within 24 hours. Adding a VRS system to your operation more than satisfies that requirement.
Either EPCIS or VRS will meet the DSCSA verification requirements.
According to the FDA, if an inbound drug product is suspect or a counterfeit, capturing the inbound PI won’t be enough to qualify for compliance. You’ll also need to make a record, quarantine the product, and notify trading partners and the FDA. OneScan® documents all of that and generates workflow instructions for your staff to follow.