Zero
Manual serial entry
Every pallet, case, and bottle tracked without rekeying a single serial number.
FDA-regulated pharmaNative NetSuite
Pharma Serialization Engine
DSCSA compliance software for NetSuite, with EPCIS built in
Automated pharmaceutical serialization from commissioning through outbound reporting. Every pallet, case, and bottle stays traceable to each other. There is zero manual serial entry, whether you are building the aggregation hierarchy or breaking it down.
Compliance controls
- EPCIS files parsed automatically from SFTP with duplicate protection
- Serial, lot, and expiry lineage maintained through every aggregation and split
- Outbound EPCIS generated automatically on every shipment
- One bulk receipt drawn down across many outbound shipments
Both
Directions supported
Aggregate up for manufacturers and repackagers, or disaggregate down for distributors and 3PLs.
1:many
Receipt to shipment
One bulk receipt draws down across many outbound shipments while lineage stays intact.
Auto
Outbound EPCIS generation
A fully formatted EPCIS file sent back to the network on every shipment.
Overview
DSCSA compliance software built into NetSuite inventory
Archer's Pharma Serialization Engine is DSCSA compliance software built natively inside NetSuite. It handles serialized aggregation in both directions, so a pallet built by a manufacturer and later broken down by a distributor stays traceable the whole way through.
Manufacturers and repackagers commission serials at packaging and roll units into cases and pallets, with parent and child links maintained automatically as they aggregate. Distributors and 3PLs work the other direction, decomposing received pallets into cases and bottles so a single receipt can be drawn down across dozens of outbound shipments without losing lot or expiry data.
Every outbound shipment kicks off a fully formatted EPCIS file back to the network on a schedule. No one has to remember to send it.
What the module does
Pharma serialization software for DSCSA and EPCIS compliance
Inbound capture
Automated inbound capture
EPCIS files from a serializer such as TraceLink pull from SFTP and parse automatically. Every pallet, case, and bottle relationship gets decoded the moment the file lands, and an inbound log record stops it from ever being processed twice.
Hierarchy transformation
Aggregation and disaggregation
This is the part that actually does the work. Item Receipt and Assembly Build records trigger inventory adjustments that roll units up or break them down, with serial numbers carried through the whole way. No manual counting, no rekeying.
- Manufacturers roll commissioned units into cases and pallets
- Distributors decompose pallets into cases and bottles
Drawdown
One receipt, many shipments
Because inventory converts down to sellable units, a single bulk receipt can be drawn down across many individual outbound shipments over time, no matter how finely it gets split.
- Each shipment pulls the correct serialized stock
- Lot, expiry, and serial data travel with every split
- No practical limit on how many orders one receipt can cover
Outbound reporting
Lot, expiry, and EPCIS reporting
Lot numbers and expiration dates stamp onto every outbound line automatically. A fully formatted EPCIS file goes out with it, ready for mobile warehouse scanning and whatever an auditor asks to see next.
Key features
NetSuite EPCIS integration built for DSCSA compliance
EPCIS ingestion
Automated file parsing
Inbound EPCIS files pull from SFTP on a schedule and parse against EPCIS structure with no manual download.
Deduplication
Inbound log record
Every inbound file is checked against the inbound log so nothing is processed twice.
Parent and child linkage
Hierarchy maintained automatically
Pallet, case, and bottle relationships stay linked as units are aggregated or split apart.
Inventory drawdown
Item Receipt to many Item Fulfillments
A single receipt draws down across many outbound shipments without losing serial detail.
Lot and expiry stamping
Populated on fulfillment and invoice
Lot number and expiration date fields populate automatically at the line level on every shipment.
Outbound EPCIS generation
Attached and transmitted automatically
A compliant EPCIS file is generated, attached to the record, and sent back to the trading partner network.
How it works
From inbound EPCIS to outbound compliance in 5 steps
- 01
Automated inbound capture
EPCIS files from your serializer, such as TraceLink, pull from SFTP and parse automatically. Every pallet, case, and bottle relationship is decoded and stored as a single source of truth, with duplicate protection built in so nothing is processed twice.
NetSuite records
- 02
Automated hierarchy transformation
The heart of the engine. For manufacturers, it rolls commissioned units into cases and pallets as outbound shipments are built. For distributors, it decomposes each received pallet into its constituent cases and bottles so stock is held at the granularity you actually sell.
NetSuite records
- 03
One receipt, many shipments
Because inventory is converted down to sellable units, a single bulk receipt can be drawn down across many individual outbound shipments over time. Each shipment pulls the right quantity of serialized stock while lot, expiry, and serial lineage stay intact no matter how finely it is split.
NetSuite records
- 04
Lot and expiry automation
On every outbound transaction, lot numbers and expiration dates stamp onto each line automatically. Data comes from what the fulfillment warehouse selects, sourced from the captured serial data. It is ready for mobile warehouse scanning systems and compliance reporting.
NetSuite records
- 05
Outbound EPCIS generation
Every shipment generates a fully formatted EPCIS file and sends it back to your serialization network on a schedule. Nobody has to remember to file it, and nobody has to build it by hand.
NetSuite records
Regulatory coverage
Two ways teams use the engine
Aggregation
Build the hierarchy
For manufacturers and repackagers
- Commission serials at packaging and roll units into cases and pallets
- Parent and child links maintained automatically as you aggregate
- Outbound EPCIS generated for every downstream trading partner
Disaggregation
Break it down, pallet to bottle
For distributors and 3PLs
- Decompose received pallets into cases and bottles in inventory
- One receipt draws down across many outbound shipments
- Lot, expiry, and serial lineage stay intact at every split
Next step
Ready to close the compliance loop
Who it is for
Built for trading partners moving serialized pharma inventory
Manufacturers and repackagers
Commissioning and aggregation
If your team is commissioning serials and building pallets, you need parent and child links that hold up without someone tracking them by hand in a spreadsheet.
Distributors and 3PLs
Bulk receipt, single unit ship
You receive pallets and ship bottles. That means pulling apart what came in, keeping the lot and expiry data attached, and doing it for every single order.
Trading partner reporting
EPCIS exchange at scale
Anyone reporting units to trading partners in EPCIS format needs those files generated and sent on schedule, not assembled by hand at the end of the week.
Quality and compliance
Zero tolerance for manual error
A single mismatched serial can trigger a much bigger conversation with an auditor than anyone wants to have. This is for teams that would rather not find out the hard way.
FAQ
DSCSA serialization and EPCIS in NetSuite
What is DSCSA?
The Drug Supply Chain Security Act is the federal law that establishes an electronic, interoperable system to identify and trace prescription drugs as they move through the United States supply chain. It requires trading partners to exchange product tracing information at the package level.
What is EPCIS and why does it matter here
EPCIS is the data exchange standard trading partners use to share serialized event data, including commissioning, aggregation, shipping, and receiving events. The engine ingests inbound EPCIS files and generates compliant outbound EPCIS files for every shipment.
Does this replace serialization hardware or line level printing
No. The engine works downstream of serialization hardware and printers. It ingests the EPCIS output from a serializer such as TraceLink and manages the aggregation hierarchy, inventory transformation, and outbound reporting inside NetSuite.
How does deduplication work on inbound files
Every inbound EPCIS file is checked against an Inbound Log record before it is processed. Files already logged are not reprocessed, which prevents duplicate serials or double counted inventory.
Can it integrate with TraceLink or other serialization networks
It can. The module is a native NetSuite application built to work with TraceLink and any EPCIS compliant network over SFTP.
How is lineage maintained through aggregation and disaggregation
Item Receipt and Assembly Build records trigger inventory adjustments that roll units up into cases and pallets or break them back down into cases and bottles. Serial, lot, and expiry data carry through each transformation.
Is the module validated for GxP environments
Archer applies Computer Software Assurance methodology across its NetSuite implementations, covering requirements documentation, configuration verification, and testing. Ask your Archer contact for the validation approach specific to this module. View CSA and CSV services.
Does this work alongside the Archer 3PL Integration module
Yes. The Pharma Serialization Engine handles serialized aggregation and EPCIS exchange, while 3PL Integration automates the broader set of transaction types moving between a 3PL and NetSuite.
Close the compliance loop