Investigation fields, statuses and rules
Odoo Enterprise: Quality app For: Administrator, Compliance manager Checked on 18.0.0.2.0, 18.0.1.0.0
The settings the add-on adds, every field it adds to an investigation, the Form FDA 3911 item each one feeds, the states an investigation goes through, and the rules that refuse a change. Investigations are in Inventory ‣ Rx Tracking ‣ Suspect Investigations; the fields below are shown only to users with an Rx Tracking right. Procedures: Investigate suspect product and Handle illegitimate product and Form FDA 3911.
Settings the add-on adds
The add-on adds two settings to the DSCSA (Rx Tracking) block of Inventory ‣ Configuration ‣ Settings. The block is shown to an administrator (Administration: Settings) who is also Rx Tracking Manager. Both settings belong to the company you are working in.
| Setting | What it does | Default | Explained in |
|---|---|---|---|
| Open an investigation on quarantine | "Quarantining a DSCSA lot that has no open investigation opens a suspect-product investigation (quality alert)." The investigation is of type Suspect product. It acts only when a lot enters quarantine: lots already quarantined when the add-on is installed get no investigation | selected | Set up investigations; Follow the investigation a lot quarantine opens automatically |
| D-U-N-S number | "Unique Facility Identifier printed on Form FDA 3911 (item 23)." | empty | Set up investigations |
Investigation fields, the Form 3911 item map, types and statuses
Header of the form
| Field | What it holds | Set by |
|---|---|---|
| DSCSA Investigation | Suspect product or Illegitimate product. Empty on a plain quality alert: an alert becomes an investigation when this is set. The field's help paraphrases the law on suspect and illegitimate product (FD&C Act § 582(c)(4); FDA suspect-product guidance (June 2021); Form FDA 3911; see Compliance background) | Suspect product by default from Suspect Investigations ‣ New and on automatic investigations; the user |
| Lot Quarantine | The lot's own quarantine state: Not Quarantined, Quarantined or Released. Read-only, shown when a lot is set | the lot |
| Investigated Owner | With the 3PL add-on only: the owner whose units are investigated; empty ("Our own stock") for your own stock. See What changes for investigations when you hold owners' stock | the user, or the software |
| Title, Product, Product Variant, Lot, Picking, Team, Responsible, Tags, Root Cause, Priority | Odoo's quality alert fields. Responsible is also the Contact Person of item 24 and the owner of the deadline activity | the user; Team and Responsible default to the first usable team and the user who creates it |
Tab DSCSA Investigation
| Field | What it holds | Form FDA 3911 item |
|---|---|---|
| Determined Illegitimate On | When the product was determined illegitimate; the 24-hour clock starts here. Shown and required only for Illegitimate product; filled with the current time when the type is set | 5 |
| Notification Deadline | 24 hours after Determined Illegitimate On. Read-only; red once overdue | none |
| FDA Notified On | When the notification was submitted to FDA | 4 |
| FDA Incident Number | The number in FDA's receipt | 2 |
| Trading Partners Notified On | When the listed trading partners were notified | none |
| Termination Requested On, Termination Approved On | When a request for termination was sent to FDA, and when FDA agreed | none |
| Trading Partners to Notify | The partners to notify; Find Trading Partners adds the partners of the lot's done receipts and deliveries | none |
Tab Form FDA 3911
| Group | Field | Form FDA 3911 item | Prefilled from |
|---|---|---|---|
| Notification | Type of Report: Initial notification, Follow-up notification, Request for termination | 1 | computed: follow-up once an FDA Incident Number is set, termination once Termination Requested On is set; can be changed by hand. Empty on an alert whose DSCSA Investigation was chosen after its form opened (known issue PF-A11-05, entry) |
| Classification: Counterfeit, Diverted, Stolen, Intentional adulteration, Unfit for distribution, Fraudulent transaction | 6 | not prefilled | |
| Geographic Location of Incident | 3 | not prefilled | |
| Company | Company Category: Manufacturer, Wholesale distributor, Dispenser (pharmacy), Repackager | 22 | the company contact's DSCSA Role (anything else gives Wholesale distributor) |
| Contact Person | 24 | the Responsible when the investigation is created | |
| Product | Name of Product (as on Label) | 7 | the product's name |
| Primary Ingredient(s) | 8 | not prefilled | |
| Drug Use: Human use, Other | 9 | Human use | |
| Drug Description: Finished prescription drug, Vaccine, Plasma derivative, Allergenic, Multiple | 10 | Finished prescription drug | |
| Strength | 11 | the product's Strength | |
| Dosage Form: Tablet, Capsule, Aerosol, Oral liquid, Sublingual, Injectable, Topical, Suppository, Other, Multiple | 12 | keywords of the product's Dosage Form text; Other when none matches | |
| NDC | 14 | the product's NDC | |
| Lot Number(s) | 16 | the lot's number | |
| Expiration Date(s) | 17 | the lot's expiry date (MM/DD/YYYY) | |
| Quantity (Number and Unit) | 13 | the lot's quantity on hand, with its unit (22 Units) | |
| (no group) | Serial Number(s) | 15 | the serials of the lot's units in your custody (In Stock, Returned, Quarantined), comma-separated, when there are 200 or fewer |
| Description of Event/Issue | 18 | not prefilled | |
| Why the Notification Is No Longer Necessary (shown for a request for termination) | 19 | not prefilled | |
| Also reported to FDA through | FAR - Field Alert Report, BPDR - Biological Product Deviation Report, MedWatch 3500, MedWatch 3500A, No Other Report, Other Report | 20 | not prefilled |
Items 21 (company name and address) and 23 (the D-U-N-S number setting) are printed from the company and are not on the tab. The prefill fills only empty items, when the investigation is created and when its type, lot or product changes (see the known issue PF-A11-04 on Open a suspect-product investigation for a lot).
Types and statuses
| State | Meaning | How an investigation gets there | What you can do next |
|---|---|---|---|
| Suspect product | A reason to believe the product may be illegitimate; no deadline | New in Suspect Investigations; every automatic investigation | Quarantine the lot from its investigation; Record that the product is illegitimate and start the 24-hour clock |
| Illegitimate product | Determined illegitimate: Notification Deadline 24 hours after Determined Illegitimate On, a yellow banner and a Notify FDA (Form 3911) activity | the user sets the type | Record the notifications to FDA and to the trading partners |
| Notification overdue | The deadline has passed, and FDA isn't recorded as notified, or trading partners are listed and not recorded as notified: red banner and red row, filter Notification Overdue. Computed when displayed | time passes | Keep notifications within the 24-hour deadline |
| Stage New, Confirmed, Action Proposed | Odoo's stages of an open investigation (the In Progress filter) | the stage bar or the kanban | move it on as your procedure says |
| Stage Solved | Closed (Date Closed is set on the Miscellaneous tab). The next quarantine of the lot opens a new investigation | the stage bar | Close an investigation |
Closing doesn't release the lot, and releasing the lot doesn't close the investigation.
Who may change an investigation, and every rule that refuses
Who may do what
| Action | Rx Tracking User | Rx Tracking Manager | Quality User or Administrator without an Rx Tracking right |
|---|---|---|---|
| See Suspect Investigations and the DSCSA fields | yes | yes | no: the alerts are in Quality ‣ Quality Control ‣ Quality Alerts without DSCSA fields |
| Create an investigation, change any DSCSA field, Find Trading Partners, print Form FDA 3911 | yes | yes | no |
| Quarantine Lot, Release Lot | no (hidden) | yes | no |
| Change the stage (close), the lot or the Odoo fields | yes | yes | yes (known issue PF-A11-01) |
| Delete an investigation | no | yes (known issue PF-A11-02) | Quality Administrator only (known issue PF-A11-02) |
The rights are set on the user form: Give staff access to investigations.
Rules that refuse
| Message | When | Who can fix it | Entry |
|---|---|---|---|
| "Only DSCSA users can change the DSCSA investigation of a quality alert." | a user without an Rx Tracking right creates or writes a DSCSA field with a value (import, API) | Rx Tracking User | Error: "Only DSCSA users can …" |
| "Only a DSCSA manager can quarantine or release a lot." | Quarantine Lot or Release Lot by a user who isn't a manager (through the API; the buttons are hidden) | Rx Tracking Manager | Error: "Only a DSCSA manager can …" |
| "Only lots of DSCSA products can be quarantined: LOT." | Quarantine Lot on an investigation of a product that isn't a DSCSA product | Rx Tracking Manager | entry |
| "Lot LOT is already quarantined." | Quarantine Lot on a page opened before the lot was quarantined | Rx Tracking Manager | entry |
| "INVESTIGATION is not a DSCSA investigation." / "INVESTIGATION: set the lot to quarantine first." | Quarantine Lot through the API on a plain alert or an investigation without a lot | Rx Tracking Manager | entry |
| "No quality team found for this company. …" | a quarantine or a new investigation in a company that can use no Quality team | Quality Administrator | entry |
| "Form FDA 3911 is only for DSCSA investigations." / "Unsupported search on the notification overdue flag." / "INVESTIGATION: set the lot first." | printing the form of a plain alert, a custom filter on the overdue flag, Find Trading Partners without a lot (through the API) | Rx Tracking User | entry |
| The date rules: "INVESTIGATION: the determination date can't be in the future.", "INVESTIGATION: FIELD is before the determination date.", "INVESTIGATION: a termination can only be requested after FDA was notified.", "INVESTIGATION: FDA can only approve a termination on or after the day it was requested." | saving the DSCSA Investigation tab with dates in the wrong order | Rx Tracking User | Troubleshooting: illegitimate product and Form FDA 3911 |
| The investigated-owner and Split per Owner refusals (3PL) | with the 3PL add-on | Rx Tracking User | Troubleshooting: suspect-product investigations |
Behaviour a tester checks
- A quality alert without DSCSA Investigation (a plain alert) gets no Form FDA 3911 values, no deadline, no activity and no date rule, and doesn't quarantine its lot. It behaves as without the add-on.
- The DSCSA fields are refused to users without an Rx Tracking right only when the new value isn't empty (known issue PF-A11-01).
- An Rx Tracking User can clear DSCSA Investigation at any time, even after FDA was notified: the record then leaves Suspect Investigations and its date rules no longer apply (PF-W26-02). With the 3PL add-on, this is refused while an Investigated Owner is set.
- An illegitimate product's deadline, banner and activity stay after the investigation is closed, until the notifications are recorded.