Quality Alert fields
The fields the Rx Tracking modules add to Odoo's Quality Alert record (quality.alert) and show on its screens, by label. Odoo's own fields are explained in Odoo's documentation.
Explained in the guide: Find and review investigations.
| Field | Explained in | Technical name | Type | Help | Module |
|---|---|---|---|---|---|
| BPDR - Biological Product Deviation Report | Investigation fields, the Form 3911 item map, types and statuses | dscsa_report_bpdr | Checkbox | Suspect product | |
| Classification | Investigation fields, the Form 3911 item map, types and statuses | dscsa_classification | Selection (see Statuses) | Form 3911 item 6. | Suspect product |
| Company Category | Investigation fields, the Form 3911 item map, types and statuses | dscsa_company_category | Selection (see Statuses) | Form 3911 item 22. | Suspect product |
| Contact Person | Investigation fields, the Form 3911 item map, types and statuses | dscsa_contact_id | Link to Contact | Form 3911 item 24: the person FDA may contact about this notification (name, phone and email are printed). | Suspect product |
| Description of Event/Issue | Investigation fields, the Form 3911 item map, types and statuses | dscsa_event_description | Multi-line text | Form 3911 item 18: when, where in the supply chain, where geographically and how the product was found; the manufacturer consulted for the determination. | Suspect product |
| Determined Illegitimate On | Investigation fields, the Form 3911 item map, types and statuses | dscsa_determination_date | Date and time | Form 3911 item 5. When the product was determined to be illegitimate; the 24-hour notification clock starts here. Set automatically when the investigation becomes illegitimate. | Suspect product |
| Dosage Form | Investigation fields, the Form 3911 item map, types and statuses | dscsa_dosage_form | Selection (see Statuses) | Form 3911 item 12. | Suspect product |
| Drug Description | Investigation fields, the Form 3911 item map, types and statuses | dscsa_drug_description | Selection (see Statuses) | Form 3911 item 10. | Suspect product |
| Drug Use | Investigation fields, the Form 3911 item map, types and statuses | dscsa_drug_use | Selection (see Statuses) | Form 3911 item 9. | Suspect product |
| DSCSA Investigation | Open a suspect-product investigation for a lot | dscsa_investigation_type | Selection (see Statuses) | Set to make this alert a DSCSA investigation (FD&C Act §582(c)(4)). Suspect: reason to believe the product may be counterfeit, diverted, stolen, adulterated, unfit or the subject of a fraudulent transaction; quarantine and investigate. Illegitimate: credible evidence that it is; FDA and the immediate trading partners must be notified within 24 hours of the determination. | Suspect product |
| Expiration Date(s) | Investigation fields, the Form 3911 item map, types and statuses | dscsa_expiration_dates | Text | Form 3911 item 17, separated by commas. | Suspect product |
| FAR - Field Alert Report | Investigation fields, the Form 3911 item map, types and statuses | dscsa_report_far | Checkbox | Suspect product | |
| FDA Incident Number | Investigation fields, the Form 3911 item map, types and statuses | dscsa_fda_incident_number | Text | Form 3911 item 2: assigned by FDA in the receipt of the initial notification. | Suspect product |
| FDA Notified On | Investigation fields, the Form 3911 item map, types and statuses | dscsa_fda_notified_date | Date and time | Form 3911 item 4: when the initial notification was submitted to FDA (CDER NextGen portal or drugnotifications@fda.hhs.gov). | Suspect product |
| Geographic Location of Incident | Investigation fields, the Form 3911 item map, types and statuses | dscsa_incident_location | Text | Form 3911 item 3: where the product was when identified (last known location if stolen). | Suspect product |
| Investigated Owner | Investigation fields, the Form 3911 item map, types and statuses | dscsa_owner_id | Link to Contact | The owner (3PL client) whose units this investigation is about. Empty: our own stock. The Form 3911 prefill and "Find Trading Partners" cover only this owner's units, and the Form 3911 names the owner as the filer. Changing it prefills the quantity, serials, company category and contact again. Fixed once FDA was notified. | 3PL Quality bridge |
| Lot Number(s) | Investigation fields, the Form 3911 item map, types and statuses | dscsa_lot_numbers | Text | Form 3911 item 16, separated by commas. | Suspect product |
| Lot Quarantine | Quarantine the lot from its investigation | dscsa_quarantine_state | Selection (see Statuses) | Quarantined lots of DSCSA products are never reserved and can't be shipped to a customer or returned to a supplier; their packages are on hold. Receipts into quarantine, internal transfers (e.g. to a quarantine shelf) and scrapping stay possible. Only a DSCSA manager quarantines or releases a lot. | Suspect product |
| MedWatch 3500 | Investigation fields, the Form 3911 item map, types and statuses | dscsa_report_medwatch_3500 | Checkbox | Suspect product | |
| MedWatch 3500A | Investigation fields, the Form 3911 item map, types and statuses | dscsa_report_medwatch_3500a | Checkbox | Suspect product | |
| Name of Product (as on Label) | Investigation fields, the Form 3911 item map, types and statuses | dscsa_product_label_name | Text | Form 3911 item 7. | Suspect product |
| NDC | Investigation fields, the Form 3911 item map, types and statuses | dscsa_ndc | Text | Form 3911 item 14. | Suspect product |
| No Other Report | Investigation fields, the Form 3911 item map, types and statuses | dscsa_report_none | Checkbox | Suspect product | |
| Notification Deadline | Investigation fields, the Form 3911 item map, types and statuses | dscsa_notification_deadline | Date and time | 24 hours after the determination: FDA (Form 3911) and all immediate trading partners that may have received the product must be notified by then. | Suspect product |
| Other Report | Investigation fields, the Form 3911 item map, types and statuses | dscsa_report_other | Text | Form 3911 item 20: any other report sent to FDA about this event. | Suspect product |
| Primary Ingredient(s) | Investigation fields, the Form 3911 item map, types and statuses | dscsa_primary_ingredients | Text | Form 3911 item 8. | Suspect product |
| Quantity (Number and Unit) | Investigation fields, the Form 3911 item map, types and statuses | dscsa_quantity | Text | Form 3911 item 13 (e.g. 6 cases, 20 bottles). | Suspect product |
| Serial Number(s) | Investigation fields, the Form 3911 item map, types and statuses | dscsa_serial_numbers | Multi-line text | Form 3911 item 15, separated by commas. | Suspect product |
| Strength | Investigation fields, the Form 3911 item map, types and statuses | dscsa_strength | Text | Form 3911 item 11, with the unit (e.g. 500 mg, 1 g/10 mL). | Suspect product |
| Termination Approved On | Investigation fields, the Form 3911 item map, types and statuses | dscsa_termination_approved_date | Date | When FDA agreed that the notification can be terminated. | Suspect product |
| Termination Requested On | Investigation fields, the Form 3911 item map, types and statuses | dscsa_termination_requested_date | Date | When a Form 3911 request for termination was sent to FDA. FDA responds in about 10 business days. | Suspect product |
| Trading Partners Notified On | Investigation fields, the Form 3911 item map, types and statuses | dscsa_partners_notified_date | Date and time | Suspect product | |
| Trading Partners to Notify | Investigation fields, the Form 3911 item map, types and statuses | dscsa_trading_partner_ids | List of Contact | Immediate trading partners that may have received the product (customers it was shipped to) or sold it to us. "Find Trading Partners" fills this from the lot's done transfers. | Suspect product |
| Type of Report | Use Quality Control checks alongside DSCSA operations | dscsa_notification_type | Selection (see Statuses) | Form 3911 item 1. Follows the investigation (initial until FDA gives an incident number, then follow-up, termination once requested); can be changed by hand. | Suspect product |
| Why the Notification Is No Longer Necessary | Investigation fields, the Form 3911 item map, types and statuses | dscsa_termination_reason | Multi-line text | Form 3911 item 19 (request for termination): why, and the corrective actions taken. | Suspect product |