OneScan Investigator

Investigator Resolves Verification Issues

When wholesale distributors make verification requests as part of saleable returns processing, it’s critical that all trading partners already have the infrastructure and processes in place to deal with any negative responses. Investigator provides an effective DSCSA workflow to manage negative responses. It provides the shared workspace and automated workflow necessary to be able to document all issues that may arise with verification requests and resolve them with the manufacturer.

Investigator Works for Everyone

Investigator is VRS-agnostic. It works with all VRS solutions and generates notification emails alerting the manufacturer for every negative response. Investigator offers robust suite of capabilities, enabling the manufacturer to:

  1. Clear an investigation, therefore rescuing good product for re-entry into inventory
  2. Conduct suspect/illegitimate product investigations with in-app email & camera
  3. Initiate, update, and terminate 3911 for illegitimate products
  4. Maintain a complete investigation history and 3911 reporting history

Investigator Meets FDA Requirements

Actions taken during a suspect product investigation are clearly recorded and documented. With Investigator, companies can demonstrate clearly to the FDA that they undertook all the necessary activities and maintained records in full compliance with DSCSA requirements.

Are You Supporting Your Customers?

Widely adopted and used by wholesaler distributors large and small,  by companies composed of between 20 to 20,000 employees, Investigator automates responses and resolves the challenges surrounding negative verification. If you are a pharmaceutical manufacturer, you have likely receive a supplier letter requesting your participation in Investigator on-boarding and registration. Please click the link in the letter to begin participation. If you have not received such a letter, please visit the Investigator page to begin the process.

Need A One-Stop Solution?

Regardless of your VRS readiness, you can use Investigator to automate your negative verification process and investigation process. If you have not yet implemented a VRS solution, be sure to check out the OneScan VRS, Verifier, and ATP modules. The robust OneScan suite is the one-stop solution for all your verification needs.

Verifier running on an Smart Scanner with pistol grip

Verifier running on a smart scanner

OneScan Verifier

Verifier is a browser-based application for Windows, iOS, and Android, supporting full functionality for mobile devices. Warehouse operators can initiate verification requests by scanning a 2D barcode using the Verifier app. Verifier automatically responds to verification requests by matching the product identifier and acts accordingly. Functionalities include:

  • 1D & 2D barcode scans
  • Verification of serialized packages
  • Negative verification alerts to manufacturer
  • Initiation of product investigation
  • In-app camera & email
  • Recalls, shelf checks, & dispositions
  • Brute force attack & phishing protection
  • Full transaction history & audit trail
  • Dashboard with 14 KPIs
  • Mobile device response

Verifier provides a complete history of every verification request and response, and the ability to sort through any failed verifications requiring action.  This type of history is especially useful when documenting suspicious product investigations where customers are required to verify products at level of individual packages.

All history records are maintained for 6+ years. In the event of an FDA audit, Verifier can easily supply reports to demonstrate compliance under the DSCSA. Verifier is available 24/7 with sub-second response times for each transaction.

Pharmacist using LSPediA OneScan Verifier to authenticate a serialized drug product

DSCSA requires Rx Verification

Verification Router Service

OneScan VRS is a Verification Router Service solution that authenticates serialized products utilizing 2D barcodes and the GS1 Short Message Standard.

Product Verification

OneScan VRS routes verification requests from the Requester (distributor/dispenser) to the corresponding Responder (manufacturer) for an immediate serial data query and response. It offers the following capabilities:

  • VRS networks – interoperability with other VRS solution providers
  • Lookup Records – GTIN master data with Connection Information
  • Lookup Directory (LD) – a global lookup directory with real-time syncing
  • APIs – Integration to enable the verification process from external ERP/WMSs
  • Exception email alerts

OneScan VRS delivers with sub-second response times 24/7/365. Positive verifications indicate products are safe to move throughout the supply chain. All verification history is stored for at least 6 years, meeting the DSCSA requirement.

Negative Verification Alert

Products verified as negative must be held for investigation. Upon negative verification, OneScan VRS automatically sends a notification email alert to the corresponding Responder. The Responder clicks on the notification record link in the email to communicate with the Requestor.

Upgrade Path

For greater DSCSA capabilities, customers with OneScan VRS can upgrade to OneScan Verifier and OneScan Investigator to manage impacted operations and enable enhanced issue tracking.

VRS as a Service (VaaS)

Enjoy the benefits of a VRS without actually needing a VRS. VaaS offers a light footprint approach to VRS. By passing EPCIS data to LSPediA, manufacturers can gain instant verification capability.

When LSPediA recieves an EPCIS file, all your serialized data will be immediately available for downstream verifications. This process is illustrated in the flow chart below:

OneScan VRS as a Servcie

The primary advantage offered by this service is the ability for manufacturers to support the efforts of both their wholesaler customers and themselves towards meeting FDA verification requirements in an easy, affordable, and hands-free manner via Eversana’s provision of VRS as a service.

VaaS frees manufacturers from the difficulties and frustrations associated with system implementation. Via this engagement, all the struggles of implementation are managed by LSPediA, allowing customers to enjoy the benefits of:

  1. Turnkey FDA verification compliance for manufacturers
  2. Meeting wholesaler customers’ requirements

VaaS delivers significant value, surpassing any other solution on the market.

DSCSA Data Security Authorized Trading Partners

Share Data with Authorized Trading Partner Only

Authorized Trading Partners

The ability to manage authorized trading partners is critical to the compliance requirements of the FDA, VAWD, and DEA, in all 50 states. In addition, DSCSA interoperability though presents opportunities to the industry, it is also associated with immense cyberthreats to data security. The ability to identify data traffic from the VRS network is the next frontier for pharmaceutical manufacturers, distributors, and dispensers.

LSPediA’s Authorized Trading Partner Module enables has a robust robust suite of operations, enabling the following capabilities:

  • Subscription to master ADR
  • ADR list construction according to current and future business
  • Management and updating of supplier and customer licensing
  • Blacklist and whitelist construction
  • Blocking of verification requests from blacklisted entities
  • Allowing of verification requests from whitelisted entities

Data security is a critical compliance baseline. Good data security practices begin with good management of authorized trading partners.

Recall Subscription

Subscribers to LSPediA’s Recall service receive the following functionalities:

  • Visibility to all products recalls
  • Daily list of new recalls
  • List of impacted orders and inventories
  • Recall warnings integrated with RxChain scanners

With the ever-increasing volume of recalls, distributors and dispensers must gain better recall visibility and capability.A subscription to LSPediA’s Recall enables distributors and dispensers to catch recalled products and prevent them from entering the supply chain.

Learn more about DSCSA verification requirements and the OneScan solution.

  • This field is for validation purposes and should be left unchanged.
Learn more about Investigator.

We implemented OneScan in Q3 2019. Our warehouse has scanned 2800+ serialized packages since then. OneScan strengthens our serialization capability as a wholesale distributor. It is an important step for us toward serialized operations. LSPediA helped us meeting the DSCSA compliance ahead of the deadline.

Frank RiveraVP Operations & Distributions, Drogueria Betances

We distribute thousands of products to thousands of customers. The ability to scan and complete a transaction is attractive to us. We are using OneScan to verify serialized products today, and we plan to apply the same automation to 3Ts, receiving, shipping, recalls, and serialization. When you give me automation, you give me my time back. We can use the time to focus on our core business – wholesale distribution with the best customer service.

Konstantin LiskovPresident, Dynasty Pharmaceuticals

Our customers use LSPediA for VRS and Serialization. Working with LSPediA has been invaluable. LSPediA has been a great partner not only in integrating our ERP software but helping us to optimize its performance.

Claudio GallinaVormittag Associates, Inc. Sr. Director

We are very compliant with rules and very strict about compliance. OneScan is just a better way for us to be compliant and enforcing rules. Instead of checking NDC, Lot, Serial, Expiry by hand, OneScan accomplishes the same with a single scan. Changing to OneScan is an easy and smooth transition.

James CroninAttain Med, Inc

I think going forward we are certainly going to see value processed through returns, not just through the returns process but also through the chargeback process. The return on the backside, so tracking serial number, lot, expiration, into our system, and then we are recording that data. So actually being able to run certain reports that will tell me these are the products that are ready to return based on manufacturer policy, that’s going to be a game changer for us in keeping our product moving, keep cash flow going, it’s going to change our process a lot.

Manager of Reverse LogisticsTop 10 Wholesale Distributor

We wanted whatever vendor we chose to provide 100 percent compliance with the FDA requirements. We also wanted this solution to integrate into our operations. We chose LSPediA. We repackage 500+ SKUs and ship to over 500 clinics. I am responsible for all inventory at our clinics. We have been using LSPediA from receiving to shipping and everything in between since 2018. The experience, the customer service, and the quality of the software have been nothing but outstanding.

Frank JulianoVP Pharmacy Services, St. Mary's Medical Park

LSPediA's RxChain is economical, user friendly, and easy to get lined up with our systems, so it’s been wonderful. We also subscribed to OneScan in 2018 and it is really simple and easy to use as well. We have been working with LSPediA for a number of years and had total faith in the company and the entire solution suite. Our serialization capabilities is ahead of our peers. We came a long way in the DSCSA journey from feeling alone and confused in 2015 to confident and achieve value beyond compliance today. We use all the solution sets from LSPediA and will continue so in the future. My company has total trust in LSPediA.

Ken RiesterVP Supply Chain and Business Development, Kowa Pharmaceuticals America Inc

OneScan VRS is implemented smoothly. We did 3 rounds of warehouse scans using OneScan Verifier. We learned a lot about our the state of our serialized inventory, 80% serialized, 94% successful scans. The numbers are actually better than we thought. It gave us confidence to take the next steps toward DSCSA's interoperability requirement. At the present time, my team is working with the LSPediA team on a serialization pilot using LSPediA's RxChain. The pilot will flush out the serialization impact and benefits for us.

Terrie StonerockVP Information Technology

We chose LSPediA, after spending a lot of time getting to know the other providers, attending system demonstrations, and speaking with other Premier wholesale distributor members. We received overwhelming positive feedback about LSPediA from our reference calls. One distributor we spoke to, changed from Tracelink to LSPediA. We learned that LSPediA responds quickly and delivers the results now, not months later. We also learned that if changes are being made, LSPediA applies the change individually tailored our company/system, always supporting our operations without interruption.
LSPediA's software impressed us and their implementation team is outstanding. OneScan is exactly the solution we were looking for.

Petra HuegelManager Claims / Returns, Drugs Unlimited, Inc.

Axway partnered with LSPediA for the Verification Router Service. Axway has a responder service but we really needed a good partner for the lookup directory. LSPediA had by far the best solution especially with the capability of upon receiving a negative response they can actually start to build the required documents for the FDA.

Jim TolandPrincipal Pre-Sales Architect, Axway

LSPediA has been a very valuable partner for Blue Link. We interact with LSPediA programmatically through LSPediA's OneScan VRS technology. Somebody is scanning a returned product 2D barcode is going to perform that scan, send the data through the API up to the LSPediA VRS and get a response instantaneously. It’s amazing how fast it works. Speaking as a technologist myself, OneScan is a great product, it works well, and our customers reap the benefits of that.

Darren MyherCEO, Blu Link ERP

My experience with LSPediA has been exceptional, and the customer service has been fantastic. I am confident that LSPediA will continue to provide us with the capability to adhere to the regulations set forth by DSCSA.

Garrison TaylorDirector of Compliance, TopRx

Nephon has a different EPCIS data repository than LSPediA. But we implemented LSPediA’s OneScan VRS solution quickly and smoothly. LSPediA built a VRS endpoint for us that allowed our EPCIS to respond to all the verification traffic from the VRS network. Integrated and automated, OneScan VRS puts our products back on the shelf when a saleable return occurs. We are getting the benefits of a streamlined process as well as supporting our distributor customers.”

Hank JibajaChief Information Officer, Nephon Pharmaceuticals