This Help Center is a preview of a future release. The final Help Center will be available on the Validation date.

FAQs

Serialized Product Intelligence

Stakeholders from Pharmaceutical Manufacturers, CMOs, and 3PLs use Serialized Product Intelligence to investigate their company's data in TraceLink.

When [Company Name] Serialized Product Intelligence is selected in the Network drop-down, the following items display in the side navigation below Do. Each navigation item provides access to a specific type of data:

  • Review Serial Number Events – View the complete event history for serial numbers.
  • Reconcile Serial Numbers – View the current state of serial numbers.
  • Monitor Commissioned Lots – View information about lots that have been commissioned in TraceLink.
  • Reconcile Lots – View all lots commissioned by the Owner and their Partners as well as the event history for specific lots.
  • Review Info Exchange Messages – View the Info Exchange messages for Track & Trace Services sent between the Owner's internal locations and external Partners.
  • Monitor Audit Trail Events – View user and system actions captured in the audit trail for Track & Trace Services and the Opus Platform.

The data in each navigation item is useful for completing certain supply chain tasks:

To do this task Go here
Monitor manufacturing activity to ensure business as usual. Monitor Commissioned Lots
View information about the items produced at each packaging level. Monitor Commissioned Lots
View the products and lots produced for each market. Monitor Commissioned Lots or Reconcile Lots
Reconcile lot production in TraceLink against the L3 system. Monitor Commissioned Lots or Reconcile Lots
View the lots commissioned at a specific location. Reconcile Lots
View the events that each lot experiences in its lifetime. Reconcile Lots
Investigate people or process problems by showing the users that took specific actions. Monitor Audit Trail Events
To do this task Go here
View information about all serial numbers received in a delivery. Reconcile Serial Numbers
View the full packaging hierarchy of a parent container and its children. Reconcile Serial Numbers
Identify a returned item with a damaged serial number.

After identifying the item, go to Review Serial Number Events to view the serial number's event history.

 Reconcile Serial Numbers
Identify a returned item with a damaged lot number (i.e. the lot number is not legible, but the serial number is). Monitor Commissioned Lots
Investigate people or process problems by showing the users that took specific actions. Monitor Audit Trail Events
To do this task Go here
Provide proof of CFR Part 11/GxP compliance. Monitor Audit Trail Events
Review all lots that experienced exceptions within a specific date range. Reconcile Lots
Reconcile a lot history's against expected compliance reports. Reconcile Lots
View the history of serial numbers to provide compliance evidence to an auditor. Review Serial Number Events
Verify the status and accuracy of EU Compliance and Russia Compliance reports. Review Serial Number Events
Investigate compliance failures and alerts. Review Serial Number Events
Reconcile the status of physical items with the corresponding serial numbers in TraceLink. Reconcile Serial Numbers
Reconcile the data in TraceLink against a WMS or ERP system. Reconcile Serial Numbers
To do this task Go here
Monitor lot activity from a specific Pharmaceutical Manufacturer or CMO Partner. Reconcile Lots
Review lots that were shipped to or from a specific Partner. Reconcile Lots
View information about Info Exchange messages sent between the Owner's internal locations or external Partners. Review Info Exchange Messages
Understand which internal locations and external Partners take specific actions frequently (e.g. which Partners send the most shipments). Review Info Exchange Messages
To do this task Go here
Investigate and diagnose the cause of supply chain exceptions (e.g. missing items in a shipment). Review Serial Number Events
Troubleshoot failed Info Exchange messages. Review Info Exchange Messages
Retrieve Info Exchange message data over a range of 1 year. Review Info Exchange Messages

Serialized Product Intelligence shows data captured from the following TraceLink events when they are performed through any app, interface, or message:

  • Serialization operations:
    • Reserve
    • Encode
    • Deactivate
    • Commission
    • End of Batch
    • Aggregation
    • Disaggregation
    • Shipment
    • Void Shipment
    • Receipt
    • Decommission
    • Destruction
    • Status Update
    • Update Lot
    • Withdrawal
    • Recall
    • Product Release
    • Market Release
  • US product verifications:
    • Product Verification Valid
    • Product Verification Invalid
  • EU Compliance:
    • Commission - Create Product Pack Data Report
    • Update Product Pack Data Report
    • All Update Product Pack State Reports (e.g. Export - Update Product Pack State)
    • Serial Number Verification
  • Russia Compliance:
    • 251 - Refusal Sender Report
    • 313 - Register Product Emission Report
    • 331 - Foreign Shipment Report
    • 332 - Foreign Import Report
    • 333 - Foreign Import Owner Report
    • 334 - Custom Move Report
    • 335 - FTS Data Report
    • 341 - Receive Importer Report
    • 342 - Release in Circulation Report
    • 381 - Move Owner Report
    • 415 - Move Order Report
    • 431 - Move Place Report
    • 441 - Move Unregistered Order Report
    • 541 - Move Destruction Report
    • 542 - Destruction Report
    • 601 - Move Order Notification
    • 603 - Move Owner Notification
    • 606 - Refusal Receiver Notification
    • 607 - Accept Notification
    • 613 - Foreign Shipment Notification
    • 614 - Foreign Import Notification
    • 701 - Accept Report
    • 911 - Unit Pack Report
    • 913 - Unit Extract Report
    • 914 - Unit Append Report
    • 915 - Multi Pack Report
    • OMS Domestic Utilisation Report
    • OMS Foreign Utilisation Report
  • Russia Crypto Codes:

    • Russia Crypto Code Response - Successful

    • Russia Crypto Code Response - Failed

Opus Platform

Passwords must be a minimum of 8 characters, must not be your email, and must include at least one:

  • Numerical digit
  • Lowercase letter
  • Uppercase letter
  • Special character

If your company was enabled on the Opus Platform from Track & Trace Services, the following password settings from Track & Trace Services apply:

  • Number of previous passwords that cannot be reused.
  • Number of login attempts allowed before the account is locked.
  • Number of days until the password expires.

If your company was not originally enabled on Track & Trace Services, the following default settings apply to TraceLink SSO:

  • The previous 6 passwords cannot be reused.
  • 5 login attempts are allowed before the account is locked.
  • Passwords expire in 30 days.

The Opus Platform supports the following web browsers:

  • Google Chrome: Versions 57, 68, 74, or above
  • Microsoft Edge: Version 80 or above
  • Microsoft Edge (Legacy): Versions 16, 17, and 18
  • Mozilla Firefox: Versions 60, 63, 67, or above
  • Apple Safari: Versions 12.1.2, 13.0, or above

The Opus Platform supports the following mobile browsers:

  • Google Chrome Mobile: Version 80.0 or above
  • Android Web View: Version 80.0 or above
  • iOS Safari: Version 13.1 or above