DSCSA compliance. Already built in.
FORGE ERP includes full FDA DSCSA compliance for pharmaceutical distributors — T3 documentation, lot tracking, chain of custody, suspicious order detection, and audit trails. FORGE covers full DSCSA interoperability requirements.
FDA T3 Documentation
Automated generation of Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS) documents. Every sale, every time.
- TI/TH/TS documents generated on every transaction
- Compliant with 21 CFR 203 and 205
- Electronic transmittal to trading partners
- Document retention for 6-year audit window
Lot Tracking & Serialization
Full lot-level inventory tracking from supplier receipt through customer delivery. Every unit accounted for.
- Lot number assignment at receiving
- Expiration date tracking and alerts
- GTIN/NDC/SNDC product identification
- Lot-level inventory queries in under 1 second
Chain of Custody
Complete pedigree records from manufacturer through every intermediary to the final recipient. Full chain visible in one screen.
- Supplier to Distributor to Customer pedigree chain
- Authorized trading partner verification
- Manufacturer, repackager, and wholesaler roles
- Returns and reverse logistics tracked
Suspicious Order Detection
T3 suspicious order monitoring with configurable thresholds. Flag unusual ordering patterns before they become compliance violations.
- Configurable order pattern thresholds
- Automated flagging for review queue
- DEA suspicious order reporting templates
- Audit trail on all flagged orders and decisions
Verification Workflows
Product verification at receiving and before dispensing. Returns verification. Saleable returns determination built into the workflow.
- Barcode scan verification at receiving
- EPCIS repository integration for verification
- Returns: saleable/unsaleable determination workflow
- Quarantine management for suspect product
Reporting & Audit Trails
Audit-ready reports for FDA inspections. 6-year data retention. Generate a full recall contact list in under 5 minutes.
- 6-year audit-ready data retention
- Recall management: contact list in under 5 min
- FDA inspection report templates
- Multi-state DEA and state license validation
Know the deadlines
DSCSA enforcement has already started. DSCSA interoperability requirements are in effect — make sure you are covered.
FORGE vs. building compliance yourself
| Requirement | FORGE | DIY / Spreadsheets |
|---|---|---|
| T3 document generation | Automated | Manual / Error-prone |
| Lot-level tracking | Built-in at receiving | Separate spreadsheet |
| Chain of custody | Full pedigree view | Multiple systems |
| Suspicious order detection | Configurable thresholds | Manual review |
| Recall contact list | Under 5 minutes | Hours / Days |
| 6-year retention | Automated | Manual archiving |
| FDA inspection readiness | Reports on demand | Scramble to compile |
DSCSA is included in Full ERP
DSCSA compliance is not an add-on module — it is part of FORGE's Full ERP plan alongside accounting, inventory, orders, approval workflows, and advanced reporting. One system for everything.
DSCSA interoperability requirements are in effect.
FORGE has full DSCSA compliance built in. Request a demo and we'll show you exactly how it works for your operation.