Healthcare & pharma

Automated healthcare & pharmaceutical distribution

Controls and automation for pharmaceutical and medical-supply distribution and pharmacy fulfillment. Accuracy, traceability, and compliance come first.

Standards

Applicable standards & regulations

We design systems aligned with these standards and regulations, applied to the scope of each project. Regulatory obligations remain with the licensed distributor or pharmacy; our controls are built to support them.

DSCSA

The Drug Supply Chain Security Act requires unit-level product identifiers, interoperable electronic tracing of transactions (typically exchanged as EPCIS data), verification of saleable returns, and quarantine and investigation of suspect or illegitimate product. The enhanced, interoperable requirements are now in effect, with FDA exemptions phasing in by trading-partner type, so automation must capture and pass serialized data reliably.

GS1 identification standards

GTIN identifies the product at each packaging level, SSCC identifies each logistic unit (case, tote, or pallet shipment), and GLN identifies locations. Together they let every scan tie a physical item to the right record.

GS1 barcodes

GS1 DataMatrix carries the DSCSA product identifier (GTIN, serial, lot, and expiry) on units and cases; GS1-128 linear barcodes carry the SSCC on shipping labels.

GS1 EPCIS

The event data standard for what happened, where, when, and why, including aggregation (which units are in which case, and which cases are on which pallet) that downstream partners rely on. See RFID & tracking.

FDA 21 CFR Part 11

Where control or WCS systems hold GxP records, electronic records and signatures need secure access, audit trails, and integrity controls. We design systems to support that.

Wholesale storage & GDP

Wholesaler storage and handling requirements (21 CFR Part 205 and state licensing) are the distributor’s obligations; Good Distribution Practice and USP <1079> guide storage and transport conditions. We build controls that help you meet them.

DEA controlled substances

Schedule II–V products require secure cages or vaults, restricted access, and documented handling. These zones shape automation layout, routing, and access-control interlocks.

Cold chain

Refrigerated (2–8 °C) and frozen zones with continuous temperature monitoring, alarming, data logging, and defined excursion handling.

GAMP 5

A risk-based approach to validating computerized systems. We provide design documents and IQ/OQ/PQ support material for systems that touch GxP data.

ISA/IEC 62443 & HIPAA awareness

Control networks segmented and secured in line with ISA/IEC 62443. Where patient-specific order data passes through (for example mail-order pharmacy), HIPAA obligations sit with covered entities and their business associates; we design systems that support your compliance.

UL 508A & NFPA 79

Control panels built to UL 508A, with machine electrical design aligned with NFPA 79.

Conveyor & machine safety

Conveyor safeguarding aligned with ASME B20.1 and OSHA requirements, with machine safety guided by ANSI B11 where it applies.

GTIN & scanning

GTIN & barcode scanning

Every decision starts with a good read.

Example only
(01)
GTIN00312345678906Product and package level
(17)
Expiry271231YYMMDD
(10)
LotA1B2C3Batch or lot number
(21)
Serial1000000001Unique per unit
Sample values for illustration. (01)+(21) together form the unique serialized identifier.

GTIN at every level

A GTIN-14 identifies the unit, inner pack, or case; for US drugs the 10-digit NDC is embedded within it, so the scan identifies the exact product and package.

Reading 2D and linear codes

Fixed-mount, image-based scanners such as Cognex DataMan, Keyence SR, Zebra, or Datalogic read GS1 DataMatrix and GS1-128, including multi-side tunnels where label orientation varies.

Parsing and validation

Application identifiers are parsed into GTIN, lot, serial, and expiry; GTIN check digits and expiry dates are validated before the item moves on.

Exceptions, not guesses

No-reads, mismatches, expired or recalled items are sent to an exception lane for review rather than passed downstream.

Data handoff

Serial, lot, and aggregation data are passed to the WMS and EPCIS systems so tracing records match what physically shipped.

Routing

Routing: from scan to shipping lane

  1. Scan
  2. LookupWMS / WCS
  3. Decide
  4. Divert
  5. Verify
  6. Shipor exception

Roles, clearly split

The WMS owns orders and inventory, the WCS or WES makes real-time routing decisions, and the PLC handles motion and I/O. Each layer does its own job.

Integration

TCP sockets, OPC UA, MQTT, REST, or database tables, with defined message handshakes and timing so decisions arrive before the item reaches the divert.

Fail-safe defaults

Unknown, late, or no-read items go to the exception lane by default, never to a guessed destination.

Order & tote routing

Totes and cartons routed to pick zones such as pick-to-light, put-walls, and A-frame or automated dispensing, with zone skipping and merges.

Induction & sortation

Carton and tote induction, then sortation to shipping lanes by carrier or route and stop.

Cold-chain & controlled lanes

Dedicated routing for cold-chain items and for controlled-substance zones with access control.

QA & audit diverts

Selected or flagged orders diverted for quality checks and audits, with recirculation handling.

Weigh, label & verify

Checkweighers confirm order contents by weight, and print-and-apply stations apply shipping and SSCC labels that are scanned to verify.

HL7 & FHIR

HL7 & healthcare systems integration

Pharmacy automation is only as good as the orders it receives and the status it reports back.

  1. EHR / pharmacy system
  2. Interface engineHL7 v2 / FHIR
  3. Automation softwareWCS
  4. PLC & equipment
  5. Status backfilled, exception, shipped

Why it matters

In hospital and health-system pharmacies, central fill, and mail-order or specialty pharmacy, automation must receive patient-specific orders from the EHR or pharmacy system and report dispense and fill status back.

HL7 v2.x messaging

The most widely used healthcare messaging standard, carried over TCP using MLLP framing. Relevant messages include ORM/OMP (pharmacy and treatment orders), RDE (pharmacy encoded order), RDS (pharmacy dispense), RGV (give), ADT (admit, discharge, transfer for location changes), and ACK acknowledgements.

Segments, in plain terms

MSH is the message header (sender, receiver, type), PID identifies the patient, ORC carries common order control, RXE holds the encoded pharmacy order, and RXD records what was dispensed.

HL7 FHIR

A newer REST and JSON standard built on resources such as MedicationRequest, MedicationDispense, Patient, and Location, used for modern integrations and APIs.

Interface engines

Integrations typically pass through the facility’s interface engine, such as Rhapsody, InterSystems HealthShare or Ensemble, Mirth Connect (NextGen Connect), Cloverleaf, or Epic Bridges, for mapping, routing, and logging. We work with the facility’s integration team.

Role split

The EHR or pharmacy system (for example Epic Willow, Oracle Health PharmNet, or a mail-order pharmacy system) sends orders through the interface engine to the pharmacy automation software or WCS, which directs the PLCs at dispensing, packaging, labeling, sorting, and verification equipment.

Data protection

PHI minimization

Where possible the PLC layer works with order and tote IDs, not patient data, keeping protected health information in the systems built to manage it.

Encryption in transit

TLS or VPN tunnels for MLLP and API traffic between systems.

Access control & audit logging

Role-based access and logs of who did what, supporting your audit requirements.

Network segmentation

Zones and conduits in line with ISA/IEC 62443 separate controls from hospital and business networks.

Supporting HIPAA obligations

HIPAA applies to covered entities and their business associates. We design systems that support your compliance program rather than claiming compliance ourselves.

Patient-specific labeling

Patient and Rx labels printed from order data and verified by barcode with print, apply & verify stations.

Capabilities

What we build

Scanning & verification stations

Fixed scanners, tunnels, and verification logic for GS1 codes.

Sortation & divert controls

Divert timing, tracking, and recirculation for accurate routing.

Pick-to-light & put-wall controls

Light-directed picking and put-walls integrated with your WCS.

Cold-chain monitoring panels

Temperature monitoring, alarming, and logging for refrigerated and frozen zones.

Controlled-substance interlocks

Access control and interlock integration for secure cages and vaults.

Checkweigh & reject

Weight checks with automatic rejection to exception handling.

WCS / PLC integration & HMIs

Clean message interfaces and clear operator screens.

HL7 / FHIR integration

Order and status interfaces between pharmacy systems, interface engines, and automation.

UL 508A control panels

Panels built to UL 508A for every part of the system.

Retrofits of legacy DC controls

Modernized PLCs, scanners, and networks with planned cutovers.

Would you like to know more? GS1 identifiers, aggregation, HL7 v2 vs FHIR, and DSCSA saleable returns verification
GS1 application identifier quick reference
  • (00) SSCC: identifies a logistic unit such as a shipping case or pallet.
  • (01) GTIN: the trade item at a specific packaging level.
  • (10) Batch or lot number.
  • (17) Expiration date (YYMMDD).
  • (21) Serial number, unique for that GTIN.
Aggregation, explained

Aggregation records parent/child relationships: these serialized units are in this case, and these cases are on this pallet (often identified by an SSCC). It lets a partner receive a pallet or case without opening it, as long as the aggregation data is accurate, which is why reliable scanning and exception handling at packing matter so much.

HL7 v2 vs FHIR

HL7 v2 is event-driven, pipe-delimited messaging pushed between systems, and remains the backbone of most hospital interfaces. FHIR exposes data as web resources over REST and JSON, which makes it easier to query and to build modern APIs. Many projects use both: v2 for established order feeds, FHIR for newer services.

ACK and NAK

Each HL7 v2 message is answered with an acknowledgement. An ACK (AA) confirms the receiver accepted it; an error or reject (AE/AR, often called a NAK) means it must be corrected or resent. Interfaces queue and retry until acknowledged, so orders aren’t silently lost.

DSCSA verification of saleable returns

Before a returned product is resold, the wholesaler verifies its product identifier (GTIN, serial, lot, and expiry) with the manufacturer, commonly through a verification router service. Scanning stations capture the identifier, the verification result is recorded, and items that fail are quarantined.

Next step

Planning a pharmaceutical or healthcare distribution project?

Tell us about your products, volumes, and systems, and we’ll help scope the scanning, routing, and controls.