| GLN (under Company GLN) | Set the company GLN and GS1 prefix length | GS1 Global Location Number of the company (13 digits), stored on the company's contact. Used as the company's party identifier and, for warehouses without their own GLN, as the location identifier. | Rx Tracking | dscsa_company_gln |
| GS1 prefix length (under Company GLN) | Set the company GLN and GS1 prefix length | Number of digits of the GS1 company prefix at the start of the GLN (6 to 12), used to split the GLN into an SGLN URN. Leave empty to assume 7 (US pharma: '03' + 5-digit labeler code). | Rx Tracking | dscsa_gs1_prefix_length |
| Wholesalers/3PLs need a 503(e) report | Set whether wholesalers and 3PLs need an FDA 503(e) report | A wholesaler or 3PL trading partner is only authorized with a current, verified FDA 503(e) annual report in addition to its state license. | Rx Tracking | dscsa_require_503e_report |
| Small-dispenser exemption | Set the small-dispenser exemption end date | Until this date, customers flagged as small dispensers may receive lot-level transaction information. | Rx Tracking | dscsa_small_dispenser_exemption_end |
| EPCIS legal notice | Review the Transaction Statement and the EPCIS legal notice | Transaction Statement notice written into outbound EPCIS files. | Rx Tracking | dscsa_ts_legal_notice |
| Transaction Statement | Review the Transaction Statement and the EPCIS legal notice | Printed on outbound DSCSA documents. Each document keeps a snapshot of the text in force when it was created. | Rx Tracking | dscsa_ts_text |
| Off-site write-once archive (S3) | DSCSA settings | Copy every posted DSCSA document (files and a JSON manifest) and every retention export to an S3 bucket with Object Lock in compliance mode. | Rx Tracking | dscsa_archive_enabled |
| Bucket (under Off-site write-once archive (S3)) | DSCSA settings | | Rx Tracking | dscsa_archive_bucket |
| Region (under Off-site write-once archive (S3)) | DSCSA settings | | Rx Tracking | dscsa_archive_region |
| Endpoint URL (under Off-site write-once archive (S3)) | DSCSA settings | Only for S3-compatible storage or a VPC endpoint, e.g. https://minio.example.com. Leave empty for AWS. | Rx Tracking | dscsa_archive_endpoint_url |
| Key prefix (under Off-site write-once archive (S3)) | DSCSA settings | Folder of the archive inside the bucket. Use a different prefix for every Odoo database that writes to the same bucket. | Rx Tracking | dscsa_archive_prefix |
| Access key ID (under Off-site write-once archive (S3)) | DSCSA settings | | Rx Tracking | dscsa_archive_access_key_id |
| Secret access key (under Off-site write-once archive (S3)) | DSCSA settings | Write-only: type a new key to replace the stored one. The stored key is never shown. | Rx Tracking | dscsa_archive_secret_key |
| S3 Secret Key Set (under Off-site write-once archive (S3)) (not shown; set by the modules) | Set up the off-site S3 archive | | Rx Tracking | dscsa_archive_secret_key_set |
| Retention (years) (under Off-site write-once archive (S3)) | DSCSA settings | Object Lock retention of each archived file, counted from the transaction date (documents) or the end of the period (retention exports). At least the six years DSCSA requires. Compliance mode: nobody, not even the AWS root user, can delete or shorten it. | Rx Tracking | dscsa_archive_retention_years |
| Test mode (under Off-site write-once archive (S3)) | DSCSA settings | For trying the archive against a test bucket only. Uploads use Object Lock GOVERNANCE mode (removable by an administrator with the bypass permission) and a retention of a few days, under <prefix>/company-<id>/test/. NOT DSCSA-compliant: records archived in test mode do not count as archived, and are queued again for a compliance upload once test mode is switched off. Never use it in production. | Rx Tracking | dscsa_archive_test_mode |
| Test retention (days) (under Off-site write-once archive (S3)) | DSCSA settings | Test mode only: Object Lock GOVERNANCE retention of each test upload, counted from when it is queued (1 to 30 days). | Rx Tracking | dscsa_archive_test_retention_days |
| DSCSA files in delivery emails | Send the DSCSA files with delivery confirmation emails | Attach the stored T3 report (PDF) and EPCIS file (XML) to the delivery confirmation email. Needs 'Email Confirmation' (Shipping section) to be enabled. Customers can also download their documents from the customer portal. | Rx Tracking | dscsa_delivery_email_documents |
| Open an investigation on quarantine | Set up investigations: D-U-N-S number, automatic investigations, Form 3911 data | Quarantining a DSCSA lot that has no open investigation opens a suspect-product investigation (quality alert). | Suspect product | dscsa_quarantine_creates_alert |
| D-U-N-S number | Set up investigations: D-U-N-S number, automatic investigations, Form 3911 data | Unique Facility Identifier printed on Form FDA 3911 (item 23). | Suspect product | dscsa_duns |