Chain of custody
Ready to receivescan match epcis confirm receipt — exceptions surface before inventory
L4 DSCSA traceability for the US supply chain
TracePharma matches your dock scan to partner EPCIS before inventory.
US manufacturers, wholesalers, 3PLs, and pharmacies run receive, exceptions, ship, and VRS in one L4 workspace. Plant-line software stays. National hubs stay.
A PDF portal is not a DSCSA system. The truck is already at the dock. The file is not. A global network is not required when you already know your partners.
- Transport
- Direct AS2, SFTP, and HTTPS to partners you already know. No mandatory exchange middleman.
- Evidence
- FDA Form 3911 starts from a failed check or exception, not a blank form.
- Cutover
- Mid-market known-partner cutovers often run 4–12 weeks. Quote follows a demo.
Where TracePharma fits
Your plant runs L3 line software. TracePharma is the L4 corporate hub—EPCIS, partners, and compliance. National hubs (L5) stay outside our product; we connect your trading partners.
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L3
Plant serialization
Line controllers, commissioning — software you already run
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L4
TracePharma
EPCIS repository, partner connectivity, exceptions, compliance workflows
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L5
National / regulatory hubs
FDA, EMVO, country hubs — not TracePharma; partners may connect upstream
Start from how you buy
New to electronic DSCSA, or already paying a network you barely operate? Pick the path that matches your floor.
New to electronic DSCSA?
Partner files in, match what arrived, verify where required, evidence for an inspector.
You do not need an enterprise network to receive partner files, match the dock scan, verify where required, and hand an inspector a package. Read what an L4 hub is and EPCIS vs ASN.
Already on a vendor
On TraceLink, LSPedia, or SAP ATTP?
Compare operator workflow and TCO for a known US partner list. Dual-run until ACKs are clean. We will tell you if you should stay.
What you get on day one
Shipped L4 capabilities your operators use on shift: receiving, ship, verify, and investigate. Not roadmap slides.
EPCIS receiving & shipping
Ingest inbound files via upload, SFTP, AS2, or webhooks so dock staff match scans to partner events instead of reconciling spreadsheets.
L3 ↔ L4 serialization
Configure an L3 forward URL and POST authored commissioning EPCIS to your plant endpoint so you ship DSCSA outbound without replacing line software.
Exception workflows
Structured reason codes and supplier correction loops so compliance leads close tickets with evidence, not email threads.
Partner connectivity
Direct AS2, SFTP, and HTTPS to your known partners so IT provisions presets without a mandatory exchange middleman.
VRS verification
Workstation and API verification with full audit log so dispensers block unverified fills and keep inspection-ready history.
Compliance exports
FDA Form 3911 prefill, verification summaries, and activity log so auditors get packages in minutes, not days of manual assembly.
Operations Hub
Scan a barcode and route to receive, verify, ship, or trace so floor staff start from one entry point instead of hunting menus.
Returns & recall
Saleable return outbound, reverse logistics scorecard, and recall investigation so manufacturer and wholesaler profiles close the loop on returns (profile-gated).
“Free” DSCSA tools often shift cost to your operators
Portals that only store PDFs leave warehouse staff, plant QA, and dispensers manually reconciling serials, chasing corrected EPCIS, and scrambling when a shipment or verification fails mid-shift.
TracePharma is built for operators who need closed-loop L4 traceability: license checks on partners, ACK health on outbound, exception investigation, and onboarding checklists that keep go-live on track.
Questions to ask any provider
- → Can I receive and ship EPCIS from the same L4 workspace?
- → Do you support L3 commissioning forward without replacing my line software?
- → Can I resolve exceptions and document supplier follow-up?
- → Is outbound ACK health visible per customer or principal?
For drug manufacturers
L4 hub from packaging line to wholesaler dock
Forward authored commissioning EPCIS to your plant-floor L3 endpoint, ship DSCSA outbound EPCIS, and monitor wholesaler ACK health without TraceLink-scale network fees or replacing the line software you already run.
Solutions by industry
One L4 platform. Profile-tuned workflows for manufacturers, wholesalers, 3PLs, dispensers, and specialty roles.
How teams use TracePharma
Same L4 platform. Different entry points depending on your operating profile.
Manufacturer
Ship with attached 3T
Forward commissioning to L3, generate outbound EPCIS, and monitor customer ACK health.
Wholesaler
Receive to ship
Match inbound EPCIS, resolve exceptions before inventory, and ship downstream with SSCC labels and partner routing. No plant commission.
3PL
3PL floor + soft principal filters
Same receive → ship spine as wholesalers, with soft principal filters on sites, ship orders, and scorecards (GA). Optional EPC custody enforcement (tenant ops; default off) gates serials per principal when enabled. Not the default product promise.
Dispenser
Verify before dispense
Receive from wholesalers, run VRS checks at the workstation or via API, and file FDA 3911 from failed verifications.
Buying group
Network control plane
Member roster, member health, exception trends, and partner authorization stay in one control plane. Invite/consent roster and Sanctum member APIs. No central receiving hub, and not an ATP substitute for members.
Frequently asked questions
- What is L4 DSCSA traceability?
- Level 4 is your corporate EPCIS hub: the system that receives shipment events from partners, matches transaction information (TI), history (TH), and statement (TS), ships outbound EPCIS, and keeps audit-ready records for FDA DSCSA. TracePharma operates at L4 for US trading partners.
- Who is TracePharma built for?
- Manufacturers, wholesalers, 3PLs, prepackagers, buying groups, and dispensers who need EPCIS-native receiving and shipping. Not a global L5 hub or EU FMD country gateway. Each tenant profile tunes navigation and workflows to your operating model.
- How do I get pricing?
- TracePharma quotes after a demo and scoping call. Packaging depends on operating profile, site count, partner connections, and optional modules. Visit the pricing page or request a demo with your organization type selected.
- Does TracePharma replace my wholesaler portal?
- TracePharma complements or replaces document-only portals by ingesting EPCIS, matching 3T data, running VRS verification where your profile requires it, and structuring exceptions with supplier accountability. It does not just archive PDFs.
See TracePharma with your workflows
Walk through the flows that match your operating profile: manufacturer outbound, wholesaler receive-to-ship, 3PL principals, or dispenser verification. Pick your profile when you request a demo.
30–45 minutes on a profile-tuned workspace. We reply within one business day.