Case study: Medical devices and life sciences

NetSuite Process Manufacturing Case Study: Formula-Based Production, Full Traceability and 3+ Years of Support for a Global Medical Device Company

A leading global medical device company headquartered in the United States needed its ERP to run regulated, recipe-driven batch production with multi-level BOMs that change as fast as R&D does. EPIQ configured NetSuite Advanced Manufacturing to mirror the shop floor step by step, embedded quality control at every checkpoint, connected machine data, and has kept the system running through ongoing NetSuite support services ever since.

The production routing EPIQ modeled in NetSuite, one operation per shop-floor station, with quality hold points built in.

  1. 1WeighingIncoming QC
  2. 2Mixing
  3. 3GranulationIn-process QC
  4. 4Drying
  5. 5Milling
  6. 6Compression
  7. 7EncapsulationBatch release

Summary: how did NetSuite handle formula-based medical manufacturing?

EPIQ Infotech configured Oracle NetSuite Advanced Manufacturing for a global medical device company so that recipe-driven batches run through a seven-operation routing, multi-level BOMs (4 to 5 nested levels) stay traceable by lot and serial number, and QC results are captured at incoming, in-process and final release checkpoints. Machine telemetry flows into NetSuite through a middleware gateway to calculate yield variance and OEE. Over more than three years of ongoing support, tickets have been limited to day-to-day operational adjustments, with no major system breakdowns.

4 to 5nested BOM levels traced from raw ingredient to finished product
7shop-floor operations mirrored as NetSuite routing steps
3embedded QC checkpoints per batch, with automated hold
3+ yrsof continuous functional and technical support
0major system breakdowns during the support period
The challenge

What manufacturing challenges did the company face?

The company develops, manufactures and distributes healthcare products across cardiology, orthopedics, endosurgery and in-vitro diagnostics. Part of its portfolio is produced through a regulated, pharmaceutical-style process flow, where active ingredients and excipients are combined and processed through weighing, mixing, granulation, drying, milling, compression and encapsulation.

That flow created requirements a standard discrete manufacturing setup could not meet:

  • Formula-based, recipe-driven production. Raw materials are consumed in precise ratios to produce the final product, so costing and scaling had to follow the formula, not a fixed parts list.
  • Highly dynamic, multi-level BOMs. Bills of material ran 4 to 5 levels deep and changed frequently with new product launches and continuous R&D work.
  • Regulatory compliance. GMP expectations meant every batch needed documented QC results and complete traceability from supplier lot to finished goods.
  • Shop-floor visibility. Production efficiency and yield had to be measured from actual machine and operator data, not estimates.
The solution

What did EPIQ build in NetSuite?

EPIQ delivered six connected workstreams inside NetSuite, each designed so production, quality and finance work from the same records.

Formula-based manufacturing

Configured NetSuite Advanced Manufacturing for recipe-driven production. Every active ingredient and excipient was mapped to an item record, and formula-based BOMs captured exact consumption ratios and scaling rules for precise batch costing.

Dynamic multi-level BOM management

Built 4 to 5 level BOM structures across Work Orders and Assemblies. Engineering Change Orders (ECOs) let R&D introduce new formulations without disrupting production already in progress.

Quality control and testing integration

Implemented the NetSuite Quality Management SuiteApp with electronic inspection forms, sampling plans and automated pass or fail rules at incoming, in-process and final release checkpoints. Results are stored in NetSuite for a full audit trail.

Process workflow customization

Used Advanced Manufacturing routing definitions to mirror the seven shop-floor operations, with SuiteFlow placing a lot on hold automatically when an in-process QC check fails.

Lot and serial traceability

Enabled lot and serial tracking across every BOM level to support GMP compliance and full traceability from raw material supplier to finished goods.

Machine-level data capture

Connected production equipment to NetSuite through a middleware gateway, so runtime counts, scrap and timestamps feed yield variance and efficiency reporting.

Under the hood

How was the shop floor modeled in NetSuite?

The physical plant was translated into three NetSuite building blocks: work centers that represent machines, routings that define the order of operations, and work orders that carry each batch through production.

NetSuite manufacturing objects used in this project
NetSuite objectWhat it representsKey attributes configured
Work Center / ResourceEach physical station: weighing station, mixer, granulator, dryer, mill, compression press, encapsulation lineCapacity, calendar, machine ID, operator skill levels, shift information
Manufacturing RoutingThe ordered sequence of operations for a product or batchSetup and run time, expected yield and scrap per step, assigned work center, linked BOM components and consumption
Work OrderOne production batchInherits BOM and routing; holds planned timings and quantities for scheduling and WIP accounting
Assemblies and sub-assembliesEach level of the 4 to 5 level BOMOwn routing where needed, lot or serial control for cross-level traceability
QC operationsHold points within the routingSampling after granulation; failed results set lot status to Hold and block the next operation

How do operators interact with NetSuite on the shop floor?

Operators use tablets or terminals running a lightweight shop floor app built as a Suitelet. For each operation they start the step (recording timestamp, operator and machine ID), record produced quantity, scrap and rejects with reason codes, record the lot numbers and quantities consumed, attach QC sample results, and complete the operation, which releases the next step in NetSuite.

How do physical batches stay linked to records?

Work order travelers and printed lot labels with barcodes or RFID tags move with each batch. Scanning a label ties the physical lot to its NetSuite record, so materials can be issued upfront or backflushed at the operation where they are actually consumed, while inventory is reserved and procurement is planned from expected consumption ratios.

Machine data integration

How does machine data reach NetSuite?

EPIQ used an edge, middleware and NetSuite pattern. Machine signals are normalized and matched to the active work order before anything is written to the ERP, which keeps high-frequency telemetry reliable and auditable.

Edge layer

  • PLCs and machine controllers
  • Run and stop, cycle count, temperature, alarms
  • Exposed via OPC-UA, MQTT or REST

Middleware gateway

  • Protocol translation (OPC to REST)
  • Maps machine IDs to work center IDs and the active work order
  • Buffering, batching, retries, idempotency
  • TLS and credential security

Oracle NetSuite

  • RESTlets or SuiteTalk REST APIs, or an iPaaS such as Boomi or MuleSoft
  • Machine Data Log custom records for telemetry
  • Operation completion records with quantity, scrap and timestamps
Inventory and accounting

What happens in NetSuite when an operation completes?

When the middleware reports good units and scrap for an operation, NetSuite posts the inventory and accounting impact automatically, in this order:

  1. Output is posted to the work order operation through a work order completion or operation completion.
  2. Components are consumed by material issue or backflush, reducing raw material inventory.
  3. Sub-assembly receipts or partial builds are created where needed.
  4. WIP entries post per operation, debiting WIP and crediting raw materials.
  5. Final completion moves WIP to finished goods, and variance journals post automatically or through scheduled SuiteScript.
  6. Scrap posts to a scrap account with reason codes, driving GL accuracy and corrective action.
Performance metrics

How are yield variance and OEE calculated?

Both metrics are computed from timestamps and counts stored in Machine Data Log records, then surfaced through SuiteAnalytics workbooks and saved searches.

Yield variance

(Expected output minus Actual output) Ă— Standard cost per unit

A scheduled SuiteScript compares planned BOM and routing output with actual good units, then creates variance journal entries or flags the work order for review.

Overall equipment effectiveness (OEE)

Availability = Run time Ă· Planned production time Performance = (Ideal cycle time Ă— Total count) Ă· Run time Quality = Good count Ă· Total count OEE = Availability Ă— Performance Ă— Quality
Ongoing partnership

How has EPIQ supported the system since go-live?

For more than three years, EPIQ has provided continuous functional and technical support for this environment as part of its NetSuite support services. Because the manufacturing model was built to match real shop-floor behavior from the start, support work has stayed focused on day-to-day operational adjustments rather than recovery from failures. There have been no major system breakdowns.

Regulated manufacturers often need more than break-fix help. A certified NetSuite support partner that understands BOM changes, QC rules and lot traceability can adjust the system as R&D introduces new formulations, without putting compliance at risk. Teams that want proactive monitoring on top of that can extend into NetSuite managed services.

  • SuiteAnalytics real-time reportingProduction, yield and OEE dashboards for operations and finance
  • SuiteFlow approval workflowsApprovals and QC holds that follow the regulated process (see our NetSuite workflows guide)
  • SuiteScript customizationsBatch expiry alerts and Certificate of Analysis (COA) generation
  • Operational adjustmentsECO updates, routing changes and configuration tuning as products launch
The results

What results did the company achieve?

One system for production, quality and finance. Formula-based BOMs, routings, QC inspections and WIP accounting all run inside NetSuite, so costing reflects actual consumption at each operation.

End-to-end traceability. Lot and serial control across all 4 to 5 BOM levels connects every finished unit to the supplier lots it consumed, supporting GMP compliance and audit readiness.

Faster product change without disruption. Engineering Change Orders let R&D introduce new formulations while production in progress continues on the current version.

Measured efficiency. Machine-level data feeds automated yield variance journals and OEE metrics, replacing estimates with shop-floor facts.

Stable operations. More than three years of support with tickets limited to routine adjustments and no major breakdowns. If your manufacturing environment needs the same steady hand, explore EPIQ's NetSuite support plans and response times.

Frequently asked questions

Can NetSuite handle formula-based or process manufacturing?

Yes. NetSuite Advanced Manufacturing supports recipe-driven production where raw materials are consumed in defined ratios. In this project, active ingredients and excipients were mapped to item records and formula-based BOMs captured consumption ratios and scaling rules for accurate batch costing.

How many BOM levels can NetSuite support for traceability?

NetSuite supports multi-level BOMs through assemblies and sub-assemblies. This medical device company runs 4 to 5 nested levels, each with lot or serial control, which provides traceability from supplier lot to finished goods.

How does NetSuite support GMP compliance for medical device manufacturers?

GMP support comes from combining lot and serial tracking at every BOM level, QC inspections through the Quality Management SuiteApp at incoming, in-process and final release checkpoints, automated holds through SuiteFlow when a check fails, and stored inspection results that form a complete audit trail.

Can machine data from PLCs be integrated with NetSuite?

Yes. Machine signals exposed through OPC-UA, MQTT or REST are collected by a middleware gateway that maps each machine to its work center and active work order, then writes data to NetSuite through RESTlets, SuiteTalk REST APIs or an integration platform such as Boomi or MuleSoft.

How is OEE calculated in NetSuite?

OEE equals availability multiplied by performance multiplied by quality. Availability is run time divided by planned production time, performance is ideal cycle time multiplied by total count divided by run time, and quality is good count divided by total count. The inputs come from Machine Data Log custom records and are aggregated in SuiteAnalytics workbooks or saved searches.

What does ongoing NetSuite support look like for a regulated manufacturer?

For this client it includes SuiteAnalytics reporting, SuiteFlow approval workflows, SuiteScript customizations such as batch expiry alerts and COA generation, and routine adjustments as products change. Learn how EPIQ structures these engagements on the NetSuite support services page.

Running regulated batch production on NetSuite?

Talk to EPIQ's certified consultants about formula-based BOMs, QC integration, machine data and the support model that keeps it all stable.

Santosh K

Santosh Krishnamoorthy is a Principal ERP Consultant at EPIQ Infotech, with extensive experience in NetSuite and enterprise systems. He works with finance and operations teams to improve reporting accuracy, streamline workflows, and build ERP environments that support sustainable growth. His writing focuses on practical insights drawn from real implementation and support experience.

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