OneScan Investigator

Investigator enhances DSCSA issue trackingOneScan Investigator helps enable productivity for issue tracking and exceptions handling across the supply chain. Negative responses on saleable return verification are managed by Investigator for efficiency and scale. Investigator delivers a new way of collaborating, making it easier to clear a false negative, identify a true negative, manage exceptions, and enhance issue tracking.

1       Do you know?

  1. Federal law DSCSA requires Rx verification and failed Rx verification identified, quarantined, investigated, and reported per DSCSA section 586(c)(2)(A)-(E).
  2. Investigator enables issue tracking and establishes higher supply chain security standard under DSCSA.
  3. Controlled testing with manufacturers is available via Investigator Pilot before go-live.

2       If you Sold Rx products, this impacts you!

  1. Wholesalers email the notification of the failed verification to manufacturers. The notification requires a direct response from the manufacturer using Investigator.
  2. All manufacturers have potential verification failures[1]. The law requires manufacturers to respond to the failed verification in 24 hours.
  3. Wholesalers disposition packages accordingly corresponding to manufacturer’s response

Investigator manages all failed VRS verifications. It informs and enables manufacturers so they can research the verification failure and respond accordingly with the automated workflow.

3       Any of these can be used to Enhance Issue Tracking

  1. Investigator Enterprise Account
  2. Investigator Notification Account

Investigator is an interactive system that enables wholesalers and manufacturers to work together in resolving verification issues. VRS, EPCIS, QMS, ERP, and other systems are not an Investigator system. However, they can be integrated to Investigator[2] for an efficient and secure platform for serial data integrity.

4       Who Can Get Investigator?

All manufacturers are eligible for getting Investigator.

  1. Manufacturers with any VRS system
  2. Manufacturers without a VRS system
  3. Manufacturers with any EPCIS system
  4. Manufacturers without an EPCIS system

OneScan Investigator is VRS agnostic, EPCIS agnostic, and ERP agnostic. It is available to all manufacturers. Click here to get Investigator.

5      How does it work?

Investigator is an ever-expanding issue tracking service that helps your organization meet your DSCSA challenges. For each negative verification, it sends an alert the manufacturer, provides a work space for manufacturer to research and determine the root cause. Manufacturer can attach records, files, pictures, and messages to support their determination. With Investigator, you  can clear the false negatives and identify true counterfeit. Investigator gives the opportunity to you to manage downstream supply chain issues, so you can work smarter, not harder:

  • Data visibility – access to customer verification transactions and identification of the root cause of verification failures
  • Product rescue – ability to rescue good products and return them to the supply chain
  • Suspect product identification – immeditely act along required guidelines to quarantine, invesitgate, and report (FDA form 3911)
  • Automation – automate workflows to ensure execution of critical product investigation activities and documentation
  • Customer service – directly support your downstream customers; perform inter-organizational supply chain investigations
  • Track full audit trails – demonstrate to the FDA that all required actions have been taken

6      Investigator On-boarding

Ready to start? Begin the On-boarding process now. For those who received  supplier letter(s) for on-boarding, you can either click the link above or use onboarding link included in your letter.

Didn’t get a letter from your customers? Click this link to request a letter.

7      Why Investigator

3 out of 10 Rx packages fail VRS verification. The most common reasons are listed below.

  • non GS1-standard barcode
  • Barcode coding errors
  • Label print errors
  • Label printing quality
  • Manufacturer does not have a VRS system
  • Manufacturer’s VRS system is not live
  • Manufacturer’s VRS system is down
  • Manufacturer’s VRS response time is slow
  • EPCIS system is missing data
  • The data in the EPCIS system mis-matches the data on the barcode

When wholesale distributors make verification requests as part of saleable returns processing, 3 out of 10 packages are verified negative. A top 5 wholesale distributor expects to manage 510 false negatives a day. A top 3 wholesaler expects to manage 16,153 false negatives a day. Given such a large volume of negatives,  it’s critically important that all manufacturers access the Investigator system to respond.

9      Need Help?

Phone:  +1 (248) 278-0075

Email: [email protected]

Download: Investigator Datasheet

Footnotes:

[1] Rx fails verification for various reasons including non-GS1-standard barcoding, barcoding errors, label print quality, lack of system, system downtime, system time out, missing EPCIS data, miss-matching EPCIS data, and more.

[2] Please note that only Enterprise account offers integration to VRS, EPCIS, QMS, or ERP systems.

Investigator Onboarding

Investigator Onboarding is easy and simple. Follow these 2 steps to complete the onboarding process.

  1. Complete the Onboarding Form
    Please complete the supplier on-boarding form. You will need to upload your GTIN datasheet you created in step 1 to the form.
    Note 1) – This form is the same as in your supplier communication letters from the wholesale distributors. If you completed the form through the supplier communication letter, you are all set. However, if you need to update any information entered previously in the form, you can re-submit this form with your new information.
    Note 2) – if you did not receive the supplier letter, you can start your on-boarding here. You can request a supplier communication letter in the on-boarding form.
  2. Register to access Investigator
    Complete your registration today. Registration is available at no cost[1] for eligible manufacturers.

After LSPEDIA verified your registration, your account will be activated. You will receive an email with a login token.

Submit / Update the GTIN Datasheet

Submitting the GTIN datasheet allows wholesale distributors to cross reference your GTINs to NDC and internal item numbers for logistics activities. It also allows the wholesale distributors to communicate to the Point of Contact specific to a GTIN. Please follow the 2-step process to submit and update your GTIN data.

  1. Download the GTIN datasheet.
    Populate the GTIN datasheet according to the instructions using the example as a reference. Save your file as “[your-company-name] GTIN Datasheet”.
  2. Upload your GTIN datasheet
    Upload your GTIN datasheet in the Onboarding Form.

If you have new GTINs and any changes to GTINs, please update your GTIN datasheet and repeat step 2 above.

Ongoing Communications

After you have completed the on-boarding process, you’ll receive communications from the LSPediA On-boarding team.

Footnotes

[1] The registration fee waiver program is sponsored by top US wholesale distributors. Eligible manufacturers can request the registration fee waiver after you have completed the registration. If you are eligible for the fee waiver program, your initial registration fee will be refunded.

Enterprise Account V. Notification Account

Enterprise account is a full license Investigator system. Notification account is a limited license system sponsored by your wholesale distributor customers requiring the manufacturers to respond to notifications.

Product Features Enterprise Account Notification Account
Test sandbox environment Y
Computer system validation with IQ, OQ, PQ Y
Notification of failed verifications Y Y
Respond to failed verifications Y Y
Attach records, files, pictures, screens to response Y Y
Respond within the notification email Y Y
View all notifications Y
Receive notification from all wholesale customers Y
View notification history Y
View response history Y
View investigations and history Y
Request pictures and records from wholesalers Y
Audit trail Y
Initiate 3911 Y
Follow up 3911 Y
Track consultation with FDA Y
Terminate 3911 Y
Role-based user security Y
User management Y

Pricing

Only authorized trading partners are allowed access to Investigator. LSPediA registers every user under the governance guideline published by Healthcare Distribution Alliance. An annual registration fee applies to each registered user. A registration fee waiver is available to eligible manufacturers[1].

  Enterprise Account Notification Account
Annual registration fees per named user $182 $182
Annual subscription fees Request Quote Free

Action Items

Complete your registration today. It’s available at no cost for eligible manufacturers[1].

Need help?

+1 (248) 278-0075

[email protected]

Footnotes

[1] The registration fee waiver program is sponsored by top US wholesale distributors. Eligible manufacturers can request the registration fee waiver after you have completed the registration. If you are eligible, your initial registration fee will be refunded.

Enterprise account provides full turnkey DSCSA compliance meeting all five verification requirements for manufacturers.

Manufacturer Requirement for Verification Enterprise Account Notification Account
582 (b)(4)(A) – Verification of Suspect Product Y
582 (b)(4)(B)- Verification of Illegitimate Product Y
582 (b)(4)(C) –Requests for Verification Y Y
582 (b)(4)(D)- Verification of Saleable Returned Product Y Y
582 (b)(4)(E) – Verification Electronic Database Y

Enterprise account provides full turnkey DSCSA compliance meeting all four verification requirements for wholesale distributors. Notification Account is used by manufacturers only.

Wholesale Distributor Requirement for Verification Enterprise Account
582 (c)(4)(A) – Verification of Suspect Product Y
582 (c)(4)(B) – Verification of Illegitimate Product Y
582 (c)(4)(C) – Verification Electronic Database Y
582 (c)(4)(D)- Verification of Saleable Returned Product Y

Learn more about serial verification and DSCSA requirement.

  • This field is for validation purposes and should be left unchanged.

Enterprise Account - Register

Notification Account - Register

We use LSPediA’s RxChain and OneScan solution. RxChain for product tracing, EDI, and EPCIS. OneScan for VRS, returns, recalls, and the customer portal. LSPediA is so easy to work with, It has been a home run. It’s fully integration with our ERP iBMI, an AS400 mainframe system, using real time SOAP APIs. Working with the LSPediA team has been great. They really know what they’re doing. I am excited about the future working with the OneScan Investigator module.

Bill CarneyVP of Operations, Genetco Inc

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

We use LSPediA's OneScan solution for VRS. LSPEDIA built an endpoint for us with integration to our custom EPCIS system. The verification transaction is lightning fast at 0.02 second per transaction. We are pleased with LSPediA's performance and we benefit from its value. It simplifies the process of Rx verification for us as a manufacturer and for our downstream trading partners. Our distributor and dispenser customers can verify and put the products back on the shelf for saleable returns.

Hank JibajaChief Information Officer, Nephon Pharma
Download Investigator Datasheet
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