OneScan™ Investigator™

Investigator™

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Investigator for Exceptions Management

Investigator is the go-to exceptions management solution for the FDA’s Enhanced Supply Chain Security requirement, a 2023 mandate under the Drug Supply Chain Security Act (DSCSA). It manages the errors and failures that arise from new DSCSA transactions including EPCIS and VRS. Without Investigator, supply chain exceptions that are not resolved in a timely manner present severe compliance and business risks:

  • Compliance gaps – FDA’s Enhanced Security requirement
  • Issues and errors in the supply chain – EPCIS and VRS exceptions
  • Overwhelming workload – error detection and resolution are complex and resource intensive

FDA DSCSA Enhanced Supply Chain Security

The DSCSA requires product tracing information at the package level for every trade and product verification at package level for every saleable returned drug product in 2023. The EPCIS 1.2 standard has been widely adopted by the pharmaceutical industry for product tracing information and Verification Router Service (VRS) for product verification for DSCSA implementation. To stay current and compliant, a pharmaceutical company needs the technology stack of EPCIS, VRS, and Investigator.

Why Investigator?

As pharma companies begin to add EPCIS and VRS into their daily operations, data errors are inevitable.

  • The average EPCIS error rate is 36% in the Production system.[1]
  • The average VRS failure rate is 44% in the Production system. [2]

Under these two categories, there are a great many different scenarios that each require different procedures, corrections, and sometimes even different personnel to manage.

By 2023, buyers will be prohibited from accepting shipments with any EPCIS errors. If EPCIS exceptions go unaddressed today, they are sure to wreak havoc on the 2023 supply chain with shipment delays, quarantines, and returns.

[1] Based on 7,720 EPCIS files processed from 20 manufacturers to 5 wholesalers in 2021

[2] Based on 57,867 verifications from 103 requestors to 49 manufacturer responders in 2021

How does Investigator manage EPCIS exceptions?

Investigator for EPCIS is built with hundreds of GS1 data rules and complex business algorithms. It detects EPCIS errors in seconds and sends real-time alerts to the sender. The sender then follows a live hyperlink in the alert to view the errors and start their resolution process. The result is a successful EPCIS data file exchange that keeps your product moving through the supply chain. 

System Architecture

Investigator can be utilized for inbound EPCIS data governance. It performs error discovery and facilitates error correction with suppliers. It delivers good data to your EPCIS system to strengthen your data quality and integrity.

Similarly, for the outbound process, Investigator receives shipment events from EPCIS or WMS, generates an accurate EPCIS 1.2 data file, and sends it to downstream customers.

Who should use Investigator?

All manufacturers, wholesale distributors, 3PLs, and dispensers should use Investigator to address supply chain exceptions. Agnostic to EPCIS, VRS, ERP, and Dispensing systems, Investigator enhances your current technological repertoire by adding the exceptions management capability to your toolbox.

Benefits

The ability to meet FDA’s regulatory requirement is paramount for all pharmaceutical businesses. The most successful pharma companies are committed to FDA compliance, customer service, and operational efficiency. They use Investigator for the following benefits:

  • Meeting FDA’s Enhanced Security requirement
  • Resolving EPCIS and VRS exceptions rapidly
  • Eliminating overwhelming exceptions workloads

Investigator is the perfect tool to mitigate compliance risks and solve difficult supply chain challenges.

Additional information

To learn more, visit https://www.lspedia.com/investigator/. For information about EPCIS and VRS solutions, visit https://www.lspedia.com/onescan/.

For sales, please call (248)458-4367 or email [email protected].

Investigator is efficient, effective, and accurate. It’s accurate because the system communicates the data. There are no typos, no human intervention, no human has to type anything with their eyes getting crossed as they count the zeros in the serial numbers. Investigator is really a great system for exceptions management.

Kelly Lacy, Product Owner Manufacturer OperationsAmerisourceBergen

We feel the pain when EPCIS files are late or error out. Shipments get set aside and pile up at receiving. With our volume, it’s impossible for us to check and catch errors manually. This needs to be addressed with automation and, Investigator is, in my mind, the best product out there to help with exceptions management.

Jeff Falardeau, Manager of Pharmaceutical Information TechnologyCardinal Health

There are challenges out there and one of the challenges is our CMOs. We reply on our CMOs and most of them are abroad. LSPediA has been instrumental in managing CMOs and getting the EPCIS data. My CEO and I placed our trust into LSPediA. I am just happy that LSPediA is in our corner because I don’t have time to check EPCIS for errors. We are a small company. I wear a lot of hats.
LSPediA took a lot of burden away from us which gives me more time to generate revenue.

Jay Madden, Director National AccountsACI Healthcare

There are challenges out there and one of the challenges is our CMOs. We reply on our CMOs and most of them are abroad. LSPediA has been instrumental in managing CMOs and getting the EPCIS data. My CEO and I placed our trust into LSPediA. I am just happy that LSPediA is in our corner because I don’t have time to check EPCIS for errors. We are a small company. I wear a lot of hats.
LSPediA took a lot of burden away from us which gives me more time to generate revenue.

Jay Madden, Director National AccountsACI Healthcare

Investigator is efficient, effective, and accurate. It’s accurate because the system communicates the data. There are no typos, no human intervention, no human has to type anything with their eyes getting crossed as they count the zeros in the serial numbers. Investigator is really a great system for exceptions management.

Kelly Lacy, Product Owner Manufacturer OperationsAmerisourceBergen

We feel the pain when EPCIS files are late or error out. Shipments get set aside and pile up at receiving. With our volume, it’s impossible for us to check and catch errors manually. This needs to be addressed with automation and, Investigator is, in my mind, the best product out there to help with exceptions management.

Jeff Falardeau, Manager of Pharmaceutical Information TechnologyCardinal Health

We feel the pain when EPCIS files are late or error out. Shipments get set aside and pile up at receiving. With our volume, it’s impossible for us to check and catch errors manually. This needs to be addressed with automation and, Investigator is, in my mind, the best product out there to help with exceptions management.

Jeff Falardeau, Manager of Pharmaceutical Information TechnologyCardinal Health

There are challenges out there and one of the challenges is our CMOs. We reply on our CMOs and most of them are abroad. LSPediA has been instrumental in managing CMOs and getting the EPCIS data. My CEO and I placed our trust into LSPediA. I am just happy that LSPediA is in our corner because I don’t have time to check EPCIS for errors. We are a small company. I wear a lot of hats.
LSPediA took a lot of burden away from us which gives me more time to generate revenue.

Jay Madden, Director National AccountsACI Healthcare

Investigator is efficient, effective, and accurate. It’s accurate because the system communicates the data. There are no typos, no human intervention, no human has to type anything with their eyes getting crossed as they count the zeros in the serial numbers. Investigator is really a great system for exceptions management.

Kelly Lacy, Product Owner Manufacturer OperationsAmerisourceBergen

Get Started With Investigator™

Download the DatasheetEnterprise Account - RegisterNotification Account - Register

Need help? Please call (248)458-4367 or email [email protected].

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Investigator enhances DSCSA issue tracking

YOUR NEW PRODUCTIVITY PARTNER

OneScan™ Investigator™ helps enable productivity for issue tracking and exceptions handling across the supply chain. Negative responses on saleable return verifications 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. Did 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 a 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 the manufacturer’s response

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

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

3. Either 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 with Investigator[2] for an efficient and secure platform for serial data integrity.

Register for New Enterprise AccountRegister for New Notification Account

4. Who can get 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 DSCSA challenges. For each negative verification, it sends an alert to the manufacturer and provides a workspace for the manufacturer to research and determine the root cause. The manufacturer can attach records, files, pictures, and messages to support their determination. With Investigator™, you can clear the false negatives and identify true counterfeits. Investigator™ gives you the opportunity 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 – immediately act along required guidelines to quarantine, investigate, and report (FDA form 3911)
  • Automation – automate workflows to ensure the 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™ onboarding

Ready to start? Begin the Onboarding process now. For those who received supplier letter(s) for onboarding, you can either click the link above or use the 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.

NEED HELP?

Call +1 (248) 278-0075 or email [email protected].

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.

Customer Testimonials

The LSPediA OneScan Investigator product allows us to work smarter, manage technical issues and negative verifications better, and not find it necessary to hire FTEs and throw other resources at the problem.

Matt Sample, VP Manufacturer Operations, AmerisourceBergen

Partnering with LSPediA to provide a VRS solution has been invaluable. They have been a great partner not only in integrating our software but also in helping us to optimize its performance.

Claudio Gallina, VP Pharmaceutical Division, VAI

We wanted to be compliant with DSCSA on day one. We looked at several different solutions for VRS and LSPediA's OneScan stood out to us the most. We're looking forward to utilizing LSPediA's software to streamline our returns process and reduce the amount of returns we receive overall.

Frank Rivera, VP Operations & Distribution, Drogueria Betances

We tested LSPediA's OneScan VRS and I’m impressed with the speed of the scans. In my previous role I managed a packaging department and had to aggregate cartons into cases and the process was slow (1-3 seconds per scan) while using other competitive solutions.

Joshua Young, Senior Manager & Head of Operations, Komtur Pharmaceuticals

Implementing RxChain has improved our accuracy drastically. In past years it was common to have one shipping discrepancy a month, sometimes more. After partnering with LSPediA, we went two years without a single shipping discrepancy. That's huge.

Bryan Brassell, Warehouse and Facilities Manager, Kowa Pharmaceuticals

Everybody at LSPediA is very knowledgeable with their products. When we ask a question they just know the answer. Everybody on staff has the knowledge and experience and that's exactly what we've been looking for.

Mark Rumble, VP Operations, Auburn Pharmaceutical

Since partnering with LSPediA we've become more efficient in our packing and shipping of products. RxChain is simple to use and anyone on our staff is able to utilize it to run the reports they need.

Roy Paul, Senior Systems Engineer, Kowa Pharmaceuticals

Before implementing LSPediA's OneScan VRS Solution and Investigator module, our entire investigation process was done via paperwork. The VRS changes all of that. We'll know whether or not product is counterfeit and that's going to help us on both the efficiency side and the quality side.

Leonardo Gil, Supervisor Returns and Inventory, Drogueria Betances

OneScan Investigator is the only solution that solves the management of anticipated volumes of negative verifications. In addition, it gives us the ability to manage suspect/illegitimate products and file FDA 3911 notifications in one place and do trading partner notifications when required.

Matt Sample, VP Manufacturer Operations, AmerisourceBergen

OneScan Investigator resolves the exceptions from the saleable returns process, keeps the products moving, and prevents negative impact to the supply chain.

Kelly Lacy, Product Owner, Manufacturer Operations, AmerisourceBergen

LSPediA had by far the best Verification Router Service out of everyone that we looked at. That's why we chose to utilize their lookup directory. We especially enjoy the automated approach to creating 3911 reports for the FDA.

Jim Toland, PreSales Engineer, Axway Healthcare

LSPediA's OneScan VRS Solution and Investigator Module improved a lot of my daily work. Rather than manually entering each individual product as they come in, I'm now able to go straight from the scanner to the system.

Beverly Wyles, Supply Chain Operations Analyst, Attain Med

With our previous provider, there was no communication and not a lot of responsibility taken for things not working. We had the interview with LSPediA and quickly realized these were the people we wanted to work with. Not just for the functionality of their software, but also for their customer service.

Mike Smith, Systems Network Administrator, Auburn Pharmaceutical

We invested a lot of time and effort looking into other software solutions for VRS. When we spoke to other companies that had partnered with LSPediA, it confirmed they had what we were looking for: personalized attention for individual companies and quick responses to inquiries.

Petra Huegel, Traffic Coordinator & Certified Quality Inspector, Drugs Unlimited

Choosing LSPediA over competing companies really came down to their knowledge. They answered all of questions confidently and had solutions for whatever we threw at them.

Terrie Stonerock, VP Information Technology, Auburn Pharmaceutical

LSPediA's OneScan VRS and Investigator module provides us with an automated, elegantly designed approach and response to Serialization.

Jessica Beaver, VP Regulatory and Business Operations, Kowa Pharmaceuticals

I would seriously recommend LSPediA. Their leadership has been awesome. Their project management skills have been terrific. The expertise and knowledge around Manufacturing, regulations, serialization, integrating systems has been incredibly valuable to us.

Ken Riester, VP Supply Chain, Kowa Pharmaceuticals

We consider LSPediA to be experts when it comes to the DSCSA and Serialization. They know and understand the ever changing regulations are are proactive on putting things in place to get us ready to go live with serialization.

Brad King, Business Operations, Kowa Pharmaceuticals

LSPediA has been a very valuable partner for Blue Link. By utilizing LSPediA's VRS our customers are able to scan 2D barcodes on returned product and get a response instantaneously. It's amazing how fast it works.

Darren Myher, CTO, Blue Link