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Supply chain planner reviewing a live shipment and cold-chain dashboard in a logistics operations center
Manufacturing & Supply Chain Solutions

End-to-end supply-chain visibility — from raw material to last mile.

Custom Supply Chain Management software for pharmaceutical, biologics, medical device, food & beverage, and specialty manufacturers. One chain of custody from supplier to customer — cold-chain temperatures, lot and serial trace, disruption alerts, and S&OP signals on a platform designed to coexist with the ERP, WMS, TMS, and carrier connections you already run.

One chain of custody
Plan → source → make → move → deliver, in one view
Cold-chain aware
Temperature, humidity & excursion alerts in context
Coexistence-first
Works with the ERP, WMS, TMS & carriers you already run
Network-wide
One platform across suppliers, plants, 3PLs & carriers
Suppliers, contract manufacturers, internal plants, warehouses, 3PLs, and carriers feed a single record per lot and per shipment — so planners, supply, and quality stop reconciling spreadsheets.
Exception-led
Disruptions surface as work, not dashboards
Late POs, missed ASNs, cold-chain excursions, short shipments, and OTIF risk surface as ranked exceptions with owners, SLAs, and routing — instead of a wall of charts no one acts on.
Lot-level trace
Forward & backward genealogy as a query
Lot, serial, and batch lineage across receiving, production consumption, transfer, and outbound — so recall, deviation, and complaint investigations are a query, not a multi-day spreadsheet exercise.
Coexistence-first
No rip-and-replace of your ERP, WMS, TMS or carrier links
Designed to coexist with the ERP, WMS, TMS, OMS, EDI, and carrier connections you already run — Dynamics 365 Supply Chain Management included. Your IT team controls the actual connectors, so existing master data and validated interfaces are preserved.

Demand, Supply & S&OP Signals

Demand forecasts, supply commitments, capacity, and inventory positions reconciled into a single planning view — with Microsoft Fabric connecting data across your source systems without complex copy pipelines, so planners, supply leaders, and commercial teams negotiate against the same numbers in a working S&OP cadence.

Supplier Onboarding & Performance

Supplier records, qualification status, contract terms, POs, ASNs, on-time / in-full performance, and quality history — so sourcing and quality teams see supplier risk and reliability instead of fragmented PO data.

Inbound, Lot & Serial Capture

Inbound shipments tracked from ASN through dock receipt — lot, serial, expiry, supplier reference, and shipping documentation linked at receipt so chain of custody starts at the door, not at the warehouse spreadsheet.

Cold-Chain & In-Transit Visibility

Carrier events, temperature, humidity, GPS, shock, and excursion alerts captured against each lot and shipment — ingested through Microsoft Azure and industrial IoT sensor feeds that link the plant floor and the lane to the cloud. Engineered with awareness of GDP, USP <1079>, and IATA CEIV Pharma expectations. Carrier qualification and disposition stay with your Quality / GDP team.

Warehouse & Inventory Choreography

Lot-level inventory positions, FEFO pick logic, transfer orders, cycle counts, and expiry watchlists — built to run alongside Dynamics 365 Supply Chain Management for real-time inventory, production planning, and warehouse operations, so warehouses and 3PLs run against the same lot truth as planning, quality, and finance.

Outbound, Returns, Recalls & OTIF

Outbound shipments, on-time / in-full tracking, customer returns, complaint linkage, and recall workflows — with an audited record of every actor, location, and transition so quality and customer-service teams act from the same evidence trail.

Cold-Chain Visibility, From the Lane to the Planner

Carrier temperature, humidity, GPS, and excursion events tied to each lot and shipment, ingested through Microsoft Azure and industrial IoT sensor feeds — so the planner, quality reviewer, and customer-service rep see the same in-transit truth in real time.

Logistics operator monitoring a live cold-chain shipment map and temperature trace on a control-tower workstation

One Chain of Custody, From Supplier to Customer

Lot, serial, supplier reference, transfer, and disposition events captured against a single record per lot — so trace, recall, and audit questions resolve in a query, not a spreadsheet.

Warehouse supervisor scanning lot-coded pallets while reviewing inbound and outbound chain-of-custody on a tablet
Engineering posture

Engineered with chain-of-custody, cold-chain, and traceability awareness for regulated supply chains

Engineering posture aligned with practices common in DSCSA, FDA FSMA 204, GDP, USP <1079>, IATA CEIV Pharma, ISO 28000, ISA-95, and C-TPAT environments

Lot, Serial & Batch Genealogy by Design

Forward and backward genealogy, lot and serial linkage, supplier reference, and material consumption are engineered into the data model — so recall trace, deviation, or complaint investigation is a query, not a spreadsheet reconstruction.

Cold-Chain & GDP Awareness

Carrier event capture (temperature, humidity, GPS, shock, excursion) is engineered with awareness of GDP, USP <1079>, and IATA CEIV Pharma expectations. Carrier qualification, lane qualification, and disposition decisions stay with your Quality / GDP function.

Audit-Trail & Data-Integrity Discipline

Schema-level lineage, immutable audit records, controlled vocabularies, and database-level constraints make supplier, PO, shipment, lot, and disposition data traceable for your Quality, Regulatory, customer-audit, and inspector reviewers.

DSCSAFDA FSMA 204GDPUSP <1079>IATA CEIV PharmaISO 28000ISA-95C-TPAT21 CFR Part 11 (where applicable)
The supply-chain control tower

Six stages, one chain of custody. Plan, source, move, and deliver in one view.

Plan, source, inbound, cold-chain transit, warehouse, and deliver — every lot, every shipment, every excursion tied to a single record your planners, quality, and trade-compliance teams act on together.

DSCSA (Drug Supply Chain Security Act)FDA FSMA 204GDP (Good Distribution Practice)USP <1079>IATA CEIV PharmaISO 28000ISA-95C-TPAT
Stage 01

Plan & Forecast

Demand signals, S&OP inputs, and supply commitments in one view.

Stage 02

Source & Suppliers

Supplier onboarding, POs, qualification, and performance scoring.

Stage 03

Inbound & Capture

ASN, receiving, lot/serial capture, and document linkage.

Stage 04

Cold-Chain & Transit

Temperature, humidity, GPS, and excursion alerts across carriers.

Stage 05

Warehouse & Inventory

Lot-level inventory, FEFO picks, and cycle-count discipline.

Stage 06

Deliver & Returns

Outbound, OTIF, returns, recalls, and continuous improvement.

The foundation

Event-driven visibility, lot-level trace, and partner coexistence — by design

  • Event ingestion & exception engine — disruptions surface as work, not noise
  • Lot, serial & batch genealogy — forward and backward trace as a query
  • Audit-ready chain of custody — actor, timestamp, location, temperature
  • ERP, WMS, TMS, OMS & carrier coexistence — your existing stack stays put

Compliance by design

DSCSA (Drug Supply Chain Security Act)FDA FSMA 204 (Food Traceability Final Rule)GDP (Good Distribution Practice)USP <1079> (Risks & Recommended Practices, Storage & Distribution)IATA CEIV Pharma (Air Cargo, Pharma)ISO 28000 (Supply Chain Security)ISA-95 (Enterprise–Control System integration)C-TPAT (Customs-Trade Partnership Against Terrorism)21 CFR Part 11 (Electronic Records & Signatures, where applicable)

Engineering artifacts for your compliance work

We structure the build so your Quality, GDP, Trade Compliance, and Regulatory teams have the documentation, traceability, and test evidence they need for their own DSCSA, FSMA 204, GDP, and customs work. We do not author SOPs, qualify carriers, or perform regulatory filings on your behalf.

Audit-trail logging as an engineering default

Every shipment, lot, transfer, excursion, disposition, and access event is logged with actor, timestamp, location, and conditions. Audit records are immutable at the database layer so your Quality, customer auditors, and regulators can read a continuous chain-of-custody history.

Lot, serial & batch genealogy as a first-class feature

Lot, serial, supplier reference, and batch linkage from receipt through transfer, production consumption, and outbound shipment are engineered into the data model — so recall trace, complaint follow-up, and FSMA 204 / DSCSA inquiries are queries against the audited record, not spreadsheet reconstructions.

Cold-chain & in-transit data integrity

Temperature, humidity, GPS, shock, and excursion events from your carrier and sensor partners are captured and time-aligned to each lot and shipment. Carrier qualification, lane qualification, and excursion disposition remain with your Quality / GDP function — the platform provides the engineered evidence trail those decisions are made against.

Identity & role-scoped access

Standards-based identity with enforced MFA, role-scoped access for planning, sourcing, warehouse, quality, trade compliance, finance, and admin populations, and least-privilege defaults across modules, APIs, and partner connections.

Cloud infrastructure for regulated supply chains

Hosted on cloud regions and configurations commonly used for regulated supply-chain workloads, with private endpoints, infrastructure defined and reviewed via Terraform, and environment promotion gates your team can sign.

Audit-ready on day one

Every component is engineered with audit-trail logging, lot and serial genealogy capture, cold-chain event recording, role-scoped access, and lifecycle artifacts your Quality, GDP, Trade Compliance, and Regulatory teams can use as inputs into their own DSCSA, FDA FSMA 204, GDP, USP <1079>, IATA CEIV Pharma, ISO 28000, and customs work. DSCSA Authorized Trading Partner status, FSMA 204 traceability filings, GDP / GxP qualification, carrier qualification, customs and export filings, and any inspection or audit outcome (FDA, CBP, EMA, MHRA, or other authority) remain solely the customer’s responsibility, executed by the customer’s Quality, Trade Compliance, or Regulatory function. Sorento Software does not represent, attest, or warrant compliance with any regulatory framework on behalf of any customer.

Partner agreements in place

DPASLAQuality / Technical Agreement (where required by the customer)

Real Visibility — Not Another Dashboard Page

Lot and shipment state, cold-chain status, inbound/outbound exceptions, and supplier performance surfaced where planners, quality, and customer service work — instead of buried in five tools that nobody reconciles.

Disruptions Surface as Work

Late POs, missed ASNs, cold-chain excursions, OTIF risk, and inventory aging surface as ranked, owned exceptions with SLAs — so operations teams act on signal instead of scrolling through charts.

Configured to Your Network — Not a Vendor Template

Your supplier tiers, your distribution model, your cold-chain lanes, your reporting set. Workflows, fields, KPIs, and approvals are configured to the way your planners, buyers, warehouse, and quality teams actually work — not bent around someone else's product.

Chain-of-Custody Your QA & Inspectors Can Stand Behind

Every lot, shipment, excursion, transfer, and disposition is captured with actor, timestamp, location, and conditions. The same engineering that gives your team live visibility also gives quality, regulatory, and customer auditors a continuous evidence trail.

No Rip-and-Replace of Your Stack

The platform is designed to coexist with the ERP, WMS, TMS, OMS, EDI, and carrier integrations you already run — Dynamics 365 Supply Chain Management estates included — and to use Microsoft Fabric for cross-system data integration rather than another round of copy pipelines. Your IT and integration teams control the connectors, so existing master data, contracts, and validated interfaces stay in place.

Our Implementation Process

1
Scoped during discovery

Discovery, Network Mapping & Engineering Framing

We walk your plan, source, make-coordination, move, and deliver workflows; inventory your existing ERP, WMS, TMS, OMS, EDI, supplier, and carrier connections; identify chain-of-custody, cold-chain, and exception-handling gaps; and frame the engineering and integration shape — before scoping the build. DSCSA, FSMA, GDP, and customs filing strategy stay with your Quality, Trade Compliance, and Regulatory functions.

Network map, current-state system inventory, chain-of-custody & cold-chain gap notes, prioritized engineering roadmap
2
Phased per engagement

Architecture & Engineering Plan

Design the SCM platform architecture, lot/serial and shipment data model, event ingestion and exception engine, partner-onboarding model, audit-trail and access posture, and ERP/WMS/TMS/OMS integration surface — including how the platform sits alongside Dynamics 365 Supply Chain Management, where Microsoft Fabric carries cross-system data integration, and how Azure and industrial IoT feeds land plant-floor and in-transit telemetry — alongside your IT, integration, security, and Quality stakeholders. Framework expectations (DSCSA, FSMA 204, GDP, USP <1079>, IATA CEIV Pharma, ISO 28000, ISA-95, C-TPAT) are built into the engineering plan as design awareness — not certification claims.

Architecture document, lot/serial & shipment data model, event-driven exception design, security architecture, integration surface outline
3
Phased per engagement

Build & Iterate

Iterative full-stack development of the SCM platform — planning view, supplier & PO, inbound capture, cold-chain & transit, warehouse & inventory, deliver & returns, and admin tooling — with engineering artifacts (test coverage, validation-support evidence, change logs) captured as part of the build. Lane-by-lane demos with planners, warehouse, and quality keep the platform anchored to real operational work.

Working SCM modules in staging, engineering artifact set, configuration documentation, audit-trail dashboards
4
Phased per engagement

Integration & Handoff to Your QA / Trade-Compliance Function

Connect to your existing ERP, WMS, TMS, OMS, EDI, supplier portals, and carrier / sensor feeds — Dynamics 365 Supply Chain Management, Microsoft Fabric data integration, and Azure IoT sensor streams included — via documented APIs and standard data formats your IT team controls. Run UAT with planning, warehouse, quality, and trade-compliance stakeholders, and assemble the engineering documentation set your Quality and Compliance teams use as inputs into their own qualification, GDP, DSCSA, and FSMA traceability work. We do not author validation protocols, qualify carriers, or perform DSCSA / FSMA filings on your behalf.

Integration runbooks, UAT sign-off, security test report, engineering documentation set for your compliance work
5
Defined per engagement

Phased Go-Live, Hypercare & Lifecycle Operations

Lane-by-lane, supplier-tier-by-tier, or region-by-region go-live so a single corridor of your network can run on the new platform while the rest of the chain continues uninterrupted. An initial hypercare period covers monitoring, defect triage, change-control reviews, and tuning so the platform stays in a known state as your network, suppliers, and SLAs evolve.

Production deployment, monitoring dashboards, change-control playbooks, hypercare support

Frequently Asked Questions

Are you offering a packaged SCM / control-tower product, or a custom build?

We are a software engineering partner that builds custom Supply Chain Management platforms around your supplier network, your distribution model, your cold-chain lanes, and the ERP, WMS, TMS, and carrier connections you already run. We do not sell a packaged, pre-validated SCM or control-tower product, and we do not perform DSCSA filings, FSMA 204 filings, GDP qualification, or carrier qualification on your behalf. What we deliver is the platform plus engineering artifacts your team uses as inputs into their own compliance work — audit logs, lot and serial genealogy, configuration history, and documentation.

What kinds of supply chains do you build SCM platforms for?

We build SCM platforms for US-based pharmaceutical (small molecule and biologics) supply chains, medical device manufacturers, food & beverage manufacturers subject to FSMA 204, and specialty / regulated process manufacturers with multi-tier, temperature-sensitive, lot-tracked supply chains. The common thread is custom: a supplier model, lot/serial data model, exception engine, and reporting set tailored to your network and the ERP, WMS, TMS, and carrier systems you already run. We are not a fit if you want a packaged, pre-validated, off-the-shelf control tower — that is a different procurement.

How does the SCM platform fit alongside our existing ERP, WMS, TMS, OMS, and carrier connections?

The platform is designed to coexist with the ERP, WMS, TMS, OMS, EDI hubs, supplier portals, and carrier / sensor feeds you already run — using documented APIs and standard data exchange formats. We build heavily on the Microsoft stack: Dynamics 365 Supply Chain Management for real-time inventory, production planning, and warehouse operations; Microsoft Fabric to connect data across systems without complex copy pipelines so operations can be analyzed quickly; and Microsoft Azure with industrial IoT to link the factory floor to the cloud through sensors and analytics. Your IT and integration teams own the actual connectors into your validated stack, so existing master data, contract terms, and validated interfaces are preserved. We do not claim partnerships, certifications, or pre-built integrations with any third-party ERP, WMS, TMS, OMS, carrier, or visibility vendor; we build the engineering surface your team uses to integrate.

Can we roll the SCM platform out one lane, region, or supplier tier at a time?

Yes — this is the default approach, not an option. Single big-bang control-tower cutovers are one of the most common failure modes in supply-chain programs, and we design against them. Each lane, region, or supplier tier is built to go live independently, with clear data and integration boundaries. This lets you prove visibility and exception handling on a single corridor, train planners and warehouse teams incrementally, and expand the rollout without disrupting commercial supply.

How does the platform handle DSCSA, FDA FSMA 204, GDP, and cold-chain expectations?

Lot, serial, supplier reference, transfer, and disposition events are captured against a single chain-of-custody record; audit records are immutable at the database layer; and cold-chain event ingestion is engineered with awareness of GDP, USP <1079>, and IATA CEIV Pharma expectations. DSCSA product identifier, transaction, and chain-of-ownership structures are engineered into the data model; FSMA 204 traceability data points are engineered into the inbound and outbound record. Authorized Trading Partner status, filings, qualifications, predicate-rule decisions, and any inspection outcome remain with your Quality, Trade Compliance, and Regulatory functions. We make no DSCSA, FSMA, GDP, or regulatory certification on your behalf.

What does a typical engagement look like, and how do you scope it?

Engagement scope, timeline, and investment vary by network and are defined during discovery — we do not quote fixed durations or fixed regulatory outcomes on a public page. Discovery is where we map your plan / source / make / move / deliver workflows, inventory the systems you already run, identify the highest-leverage corridor (often a single cold-chain lane or supplier tier that represents your hardest exception pattern), and frame the engineering and integration shape before any production-bound code is written. The build is typically phased so the highest-priority lane goes live first and your team can review the platform before later phases land.

Looking for an SCM platform that fits your network?

Book a free 30-minute discovery call. We will walk through your plan, source, make, move, and deliver workflows, the systems you already run, and the engineering shape of a custom Supply Chain Management platform — and outline a realistic, phased scope for your network. DSCSA, FSMA, GDP, carrier qualification, and any regulatory or inspection outcomes remain with your team.