Compliance manager
People who keep licenses, holds, trace requests, investigations, records and the 3PL's own compliance. Access: Rx Tracking Manager.
Abbreviations on this page: GLN (Global Location Number), GTIN (Global Trade Item Number), NDC (National Drug Code), EPCIS (Electronic Product Code Information Services), SSCC (Serial Shipping Container Code), T3 (Transaction Report).
Set up once
Getting started
- Configure Rx Tracking in the first 30 minutes
- Load products, trading partners and licenses from a spreadsheet
- Go live with stock and records you already have
- Prove the whole chain once after go-live
Core guide
- Set up a DSCSA product
- Onboard a trading partner: DSCSA role, GLN and address
- Record our own company's licenses
- Register the opening balance for stock that predates the package ledger
3PL guide
- Record and verify our facility licenses
- Record that a state does not license 3PLs
- Create an owner profile
- Set how the owner's documents are issued
- Set the owner's policies
- Allow title transfers or just-in-time transfers, or make the owner a consignor
- Give an owner's contacts the owner portal
- Know who receives an owner's documents: issuing mode A or B
- Register an opening balance of units held for an owner
- Get ready for title transfers in place
- Set up an owner for just-in-time buying
- Go live as a 3PL: the setup order, and owner stock you already hold
Decide with your administrator
Decide these with your administrator, who changes the setting:
- Review the Transaction Statement and the EPCIS legal notice
- Set whether wholesalers and 3PLs need an FDA 503(e) report
- Set the small-dispenser exemption end date
- Choose the company's 3PL policies
- Choose the hold scope: whole lot or per owner
- Set up investigations: D-U-N-S number, automatic investigations, Form 3911 data
Every day
Core guide
- Work the DSCSA activities in your to-do list
- Watch the archive queue and each record's archive state
- Find a product by NDC or GTIN, or a partner by GLN
- Check whether a partner is an authorized trading partner, and why not
- Flag a small-dispenser customer and record its attestation
- Record and verify a trading partner's license
- Renew, correct or retire a verified license
- Act on license-expiry reminders
- Import the supplier's EPCIS file on the receipt
- Receive a sealed case by scanning its SSCC label
- Validate a DSCSA receipt
- Receive part of a shipment
- Scan units onto a receipt with Scan Serials, and undo a scan
- Capture a product's GTIN from the first scan
- Receive without a supplier EPCIS file
- Review supplier EPCIS files and the inbound DSCSA document
- Scan the serials of a delivery and validate it
- Ship part of a delivery, or ship in pick, pack and ship steps
- Ship at lot level to an exempt small dispenser
- Open the DSCSA document a delivery posted
- Find, view, download and print DSCSA documents
- Send one document's link to a customer
- Receive a saleable customer return with its serials
- Verify returned units for resale, or reject and destroy them
- Return saleable product to the supplier
- Review the lots on hold, and why they are held
- Keep trace requests within the 24-hour deadline
- Check the package ledger against the stock (Ledger vs Stock)
- Count stock and record the units that are gone
- Look up a unit in the package ledger
- Get the monthly retention export, or export on demand
- Verify the integrity of the DSCSA documents
3PL guide
- Record an owner's instruction
- Find an owner's instructions and see which are used
- Create a receipt held for an owner
- Attach the supplier's EPCIS file to an owner's open receipt
- Scan and validate an owner receipt
- Record the owner's confirmation or the supplier's statement before validating
- Receive the owner's own goods as a custody receipt
- Put away and move an owner's units inside the warehouse
- Move an owner's units to another of our warehouses
- Work the Supplier Data Pending list
- Record supplier data the owner uploaded through its portal
- Record an owner order
- Confirm an owner order
- Pick, scan and ship an owner order
- Send an owner's goods back to it (custody return order)
- Read an owner's outbound document
- Read an owner's inbound document and the history of owner documents
- Send an owner its documents
- Publish a mode-A owner document to its buyer
- Find and read the notices sent to an owner
- Take back a customer return of units an owner sold
- Verify an owner's returned units for resale
- Return an owner's units to its supplier, or to the owner in custody
- Count an owner's stock and record the units that are gone
- Select the serials that change owner
- Check and validate a title transfer
- Import the owner's transfer file on a title transfer
- Sell units back to an owner in place (reversion)
- Record a sale between two owners in place
- Ship our own sale that takes a just-in-time owner's units
- Pick, pack and ship when a just-in-time owner holds the product
- Take in and sell consignment stock
- Find and read the in-place documents of a title transfer
- Record a facility's FDA annual report and mark it submitted
- Act on the FDA annual report reminders
- Print the FDA annual report summary
- Review the gate log and export it for an inspector
- Print or export the facility client list
- See the stock we hold for each owner (Owner Stock)
- List the serial numbers we hold for an owner (Owner Serials)
- Follow an owner's stock movements (Owner Movements)
- Export the selected rows of an owner report as a CSV file
- Find the DSCSA documents issued in an owner's name or received for it
- Review returns of owners' units
- Check every serial's recorded owner against the stock (Ledger vs Stock per Owner)
- Export everything we keep about one owner as one zip
Barcode app
- Receive DSCSA units in the Barcode app
- Pick and ship a delivery in the Barcode app
- Move DSCSA stock internally, or in pick and pack steps, in the Barcode app
- Process a return in the Barcode app
- Count DSCSA stock in the Barcode app
- Scan owner stock in the Barcode app
- Scan a lot on an owner transfer: the owner-aware lot pre-fill
Suspect product
When something goes wrong
Core guide
- Fix and retry failed archive uploads
- Get a record back from the off-site archive and check it
- Stop treating a product as DSCSA, duplicate it or archive it
- Fix a missing GLN before shipping
- Read the warnings of an imported supplier EPCIS file
- Replace a supplier file with a corrected one before validation
- Cancel a supplier file, or a receipt that has scans or a file
- Correct a receipt after validation
- Record the supplier's Transaction Statement before validating
- Record a missing Transaction Statement after validation and release the lots
- Work a receiving discrepancy to resolution
- Handle a duplicate serial at receipt
- Correct the scans of an open delivery
- Handle a document posted without an EPCIS file
- Take back units shipped at lot level to a small dispenser
- Send a non-saleable return to the supplier
- Quarantine a lot so it can't be reserved or shipped
- Release a lot from quarantine
- Move quarantined stock to a quarantine shelf
- Scrap DSCSA units, naming each unit's serial
- Log a trace request from the FDA, a state or a trading partner
- Search the records a trace request asks for
- Respond to a trace request with the response zip, and send it
- Cancel a trace request that needs no answer
- Record units found in a count
- Correct a lot's number or expiry after documents were posted
- Place a legal hold on DSCSA documents
- Release a legal hold
3PL guide
- Check whether an owner is an authorized trading partner, and fix it
- Change, end or re-open an owner relationship
- Take the owner portal away from a contact
- Receive an owner's goods before their data
- Release a data-pending hold with the supplier's late EPCIS file
- Release a data-pending hold with the supplier's transaction statement document
- Release a data-pending hold with the owner's confirmation
- Resolve the differences a late supplier file finds
- Change, cancel or delete an owner order
- Ship an owner's units without an owner order
- Answer a trace request about an owner's records
- Answer a trace request about our own records while we hold owners' stock
- Send a notice that could not be emailed
- Put a lot that holds owner units on hold
- Release a lot that holds owner units, with each owner's release instruction
- Follow an owner hold placed by an owner receipt
- Clear a documentation owner hold by recording the missing documentation
- Release a transaction-information mismatch owner hold
- List the customers an owner's units of a lot were shipped to
- Recall an owner's lots on its recall instruction
- Reject and destroy an owner's returned units on its destroy instruction
- Take back units an owner shipped at lot level to a small dispenser
- Send an owner's nonsaleable units to the owner or one of its return designees
- Record owner units found in a count
- Scrap an owner's units on its scrap or destroy instruction
- Record the seller's Transaction Statement that the owner's file does not affirm
- Resolve serials the owner's file lists that can't change owner (Title Not Held)
- Cancel or correct a title transfer or a title purchase order
- Stop just-in-time buying or end a consignment
- Record a facility event and mark it reported to FDA
- Get an owner transfer through the owner, counterparty and facility checks
- Review the receiving discrepancies of owners' receipts
- See which owners' units are on hold (Owner Holds report)
Barcode app
Suspect product
- Open a suspect-product investigation for a lot
- Follow the investigation a lot quarantine opens automatically
- Quarantine the lot from its investigation
- Release the lot from its investigation
- Record that the product is illegitimate and start the 24-hour clock
- Find the trading partners to notify
- Complete and print the Form FDA 3911 data sheet
- Record the notifications to FDA and to the trading partners
- File a follow-up, or request the termination of a notification
- Close an investigation
- Open an investigation of an owner's units
- Follow the automatic investigations of a lot that holds owners' units
- Split an investigation per owner
- Quarantine and release, from an investigation, a lot that holds owners' units
- Prepare an owner's trading partners and Form FDA 3911, and hand them to the owner
- Change the investigated owner
Troubleshooting
- Fix an "Only DSCSA users or managers can ..." refusal or an Odoo access error
- Find the troubleshooting entry for a message
- Resolve a delivery that refuses to validate
- Fix an operation refused for its owner instruction
- Fix a supplier file refused on an owner receipt
- Resolve an owner-isolation refusal
- Resolve trace-request refusals that concern owners
- Resolve a title transfer refused at Check or Validate
- Resolve a delivery refused because of a just-in-time owner's units
- Fix a transfer that won't validate from the Barcode app
Reference you'll use
Core guide
- Fields and statuses the core module adds to Odoo screens
- The T3 report, and why a validated delivery can't be edited
- The outbound EPCIS 1.2 file
- How the transaction history and the direct-purchase flag are built
- What is kept, and what can never be deleted or changed
3PL guide
- 3PL settings and the fields the add-on adds to existing screens
- Which 3PL setup records and files are kept for good
- Which owner instruction each operation needs
- What an owner-scoped trace response contains
- Which operations notify an owner, and what each notice says
- What an owner hold blocks, how holds combine, and when a release needs the owner's instruction
- What the owner export zip contains, and how to verify it
- The owner column of the retention export and of packages.csv
Suspect product
- Investigation fields, the Form 3911 item map, types and statuses
- Who may change an investigation, and every rule that refuses
- Suspect and illegitimate product without Odoo Enterprise
- What changes for investigations when you hold owners' stock