Pharmaceutical Traceability & Compliance Software

Advanced Pharmaceutical Management Solutions for DSCSA Serialization, GMP Compliance, and Fast, Targeted Recalls

KnarrTek's pharmaceutical management solutions — BellHawk and MilramX — give manufacturers and distributors real-time lot and serial tracking, DSCSA-compliant serialization, and audit-ready traceability records built for FDA's CFR 21 Part 11, DSCSA, and GMP standards. Every scan feeds one record, so a recall stays as narrow as the problem that caused it, and consumer safety and brand reputation stay protected.

  • Real-Time Lot & Serial Tracking
  • DSCSA-Compliant Serialization
  • GS1 Label Automation
  • Barcode & RFID Capture
  • GMP Quality Documentation
  • ERP Integration
ReceiveRaw materials & lots logged
CompoundProduction steps tracked
PackageUnits serialized
LabelGS1 barcode applied
ReportTraceability record assembled
SyncERP updated
Built for One-Step Traceability, Not a Recall Scramble

What KnarrTek actually does for pharmaceutical operations

BellHawk and MilramX, KnarrTek's pharmaceutical management solutions, aren't paperwork you assemble after the fact when an auditor or a recall shows up. They're the system that captures lot, serial, and component data the moment it moves, so a compliant traceability record is already built by the time anyone asks for it.

01

Real-Time Lot & Serial Tracking

Barcode and RFID scans update material, lot, and unit status the moment they move, so what's in the system matches what's actually on the line.

02

DSCSA-Compliant Serialization

Unit-level serial numbers and GS1 barcodes are generated automatically from the same record that tracks the product, so labeling always matches the history behind it.

03

Audit-Ready Traceability Records

Every scan writes to the record automatically, so documentation for FDA and DSCSA audits is assembled as work happens instead of reconstructed under deadline.

04

Rapid, Targeted Recalls

One-step-forward and one-step-back traceability lets you identify exactly which units are affected, instead of pulling an entire lot to be safe.

What's Actually Putting Compliance at Risk Right Now

The traceability gaps pharmaceutical operations deal with today

These challenges show up across manufacturers, distributors, and multi-site operations alike — and they're the ones KnarrTek's platforms are built to close.

01

Recall Scope You Can't Control

Without lot- and serial-level traceability, a single defect can force a recall of an entire production run instead of the units actually affected.

02

Manual Serialization & Traceability Records

Assembling traceability records by hand from paper batch logs and separate spreadsheets eats staff time and leaves gaps that are hard to explain during an FDA inspection.

03

Fragmented Systems & Manual Records

When the ERP, quality system, and paper logs don't talk to each other, staff spend real time reconciling records instead of moving product through the line.

04

Rising Operational Costs

Manual data entry, rework from transcription errors, and duplicate systems all add hidden cost that's hard to see until it's added up over a year.

Wide view of a pharmaceutical production line with barcode scanning and labeling stations, illustrating the pharmaceutical management solutions KnarrTek builds for manufacturers and distributors.
Five Connected Capabilities

What BellHawk does for pharmaceutical operations

BellHawk is a robust Manufacturing Execution System (MES) and Warehouse Management System (WMS) designed for pharmaceutical manufacturers and distributors. It replaces paper forms and manual data entry with barcode scanning and mobile devices, supporting compliance with FDA's CFR 21 Part 11, DSCSA, and GMP standards. BellHawk's real-time tracking and traceability capabilities help organizations avoid costly recalls, protect brand reputation, and maintain consumer safety.

01

Materials Tracking

Monitor materials by lot and serial number, storage locations, expiration dates, quality control metrics, and hazardous material classifications.

02

Traceability Records

Capture data on ingredients used in products, enabling quick forward and backward traceability to pinpoint defect origins and reduce recall scope.

03

Quality Assurance

Document every production step, including quality assurance checks and test results, to comply with GMP and internal quality standards.

04

Label Automation

Generate GS1-compliant barcode labels tailored to products and customers, ensuring precision and regulatory adherence.

05

Live Data Insights

Offer a real-time overview of inventory, production progress, equipment usage, labor, quality checks, and order fulfillment.

KnarrTek pharmaceutical management architecture diagram: raw material receiving, compounding, and packaging activity connect via barcode and RFID scans to the BellHawk engine, which posts to the traceability record driving GS1 labeling, DSCSA serialization, and ERP sync through MilramX.
How the System Connects

From raw material receiving to a compliant traceability record, in real time

BellHawk supports a wide range of pharmaceutical operations, helping manufacturers and distributors improve traceability, inventory visibility, and production control across regulated environments. The platform provides real-time tracking for materials, inventory, assets, and production activity while supporting FDA compliance initiatives and lot-level traceability requirements. Whether managing inventory across multiple facilities, monitoring work-in-process, coordinating packaging and labeling operations, or improving recall readiness, BellHawk helps streamline workflows and reduce manual processes — integrating seamlessly with existing ERP and accounting platforms like QuickBooks or Oracle, without replacing current business systems.

  • Pharmaceutical manufacturing and packaging, ensuring traceability and quality control.
  • RFID asset management for multi-site operations, plus real-time product labeling and traceability.
  • Multi-site operations, integrating tracking across geographically distributed plants and distribution centers.
  • Integration with existing ERP or accounting systems like QuickBooks or Oracle, avoiding costly replacements.
Discuss your traceability requirements
Manufacturing and Distribution Efficiency

What happens to a lot as it moves through production

Each of these stages is a real sequence a BellHawk-enabled operation follows, and each one writes something to the record — so a traceability record builds itself, recalls stay narrow, and downstream systems stay current automatically instead of by hand.

Receive & Track

Raw materials are received and tracked with barcode scanning on arrival, ensuring accurate inventory and compliance from the first scan.

Produce & Verify

Production processes like mixing, compounding, and packaging are monitored in real time, with quality control checks and GS1 label printing automated along the way.

Distribute & Report

Picking, packing, and shipping run on real-time data integration, while detailed traceability records for FDA and DSCSA compliance stay ready for regulatory audits.

KnarrTek pharmaceutical workflow diagram: raw materials are received and tracked, production is monitored and verified in real time, and completed units are serialized and labeled with a traceability record generated and synced to ERP with a full audit trail.
Technician scanning a GS1 serialized barcode label on a finished pharmaceutical package, illustrating how KnarrTek's BellHawk platform assembles the DSCSA traceability record at the point of work.
The Record a Recall or Audit Actually Needs

Serialization and DSCSA traceability, built as work happens

A DSCSA traceability record is only useful if it's complete and it's fast to pull. BellHawk assembles it automatically as raw materials are received, compounded, packaged, and serialized — so the full chain of custody for a unit is one lookup away, not a week of digging through paper batch records.

KnarrTek DSCSA traceability diagram: raw materials and lots are logged, compounded, and packaged, a GS1 serialized label is generated, the DSCSA traceability record is assembled, and the record links forward to chain-of-custody documentation and backward to suspect-product investigation.
01

GS1 Serialization & Labeling

Unit-level serial numbers and GS1-compliant barcodes are generated directly from the production record, so the label on the package always matches the history behind it.

02

DSCSA Traceability Record Assembly

Every receipt, compounding step, packaging run, and quality check writes into the same record, assembling transaction history, information, and statement data automatically instead of by hand.

03

Suspect & Illegitimate Product Investigation

A suspect-product notice links directly back to the specific lot and materials involved, so investigations start with the record instead of a search.

Cloud, On-Premise, and Multi-Site

Deployment flexibility for pharmaceutical environments

KnarrTek's platforms adapt to how and where operations actually run, supporting minimal disruption during implementation and long-term scalability as your site count and production volume grow.

Browser-Based Access

Cloud-hosted tracking for inventory, lots, and production status, visible the moment they're scanned, with no local server to maintain.

Rugged Mobile & Offline Capture

Mobile devices capture barcode and RFID scans on the line even with limited connectivity, synchronizing automatically once a connection is restored.

Multi-Site Networks

Data capture stays local at each site while centralized dashboards give leadership real-time visibility across every plant and distribution center.

Real-Time Decision Support

Where MilramX extends BellHawk with automation

MilramX is a real-time, rules-based decision support platform that enhances supply chain coordination and data exchange. Built on the Microsoft stack (Visual Studio, IIS, SQL Server), MilramX provides intelligent, automated solutions for materials management, integrating seamlessly with BellHawk and other systems like ERP, QuickBooks, or Oracle — so managers receive actionable, real-time information to make informed decisions, reducing delays and improving efficiency.

01

Smart Automation

Employs an intelligent-agent framework to manage parallel tasks like data transfers and notifications, optimizing supply chain processes.

02

Data Integration

Collects and processes data from multiple systems, converting it into High Level Data Objects (HLDOs) for streamlined operations.

03

Operations Dashboard

Monitors purchase orders, work orders, move orders, and shipments in real time for enhanced oversight.

04

Error Management

Features automated error detection and correction for continuous operation, with alerts for IT support when needed.

05

Adaptable Integration

Connects with ERP, CRM, and other systems, supporting applications in pharmaceuticals and related industries like medical supply chains.

Read the KnarrTek white papers

What Changes on the Line and in Quality

Why pharmaceutical operations choose KnarrTek

KnarrTek's solutions address the challenges of modern pharmaceutical manufacturing, from serialization to regulatory compliance — eliminating manual paperwork while MilramX enhances decision-making with real-time data integration.

Rapid Traceability

Enables instant one-step-backward and one-step-forward tracking to support FDA and DSCSA compliance, minimizing recall scope.

Cost Savings

Operations commonly report meaningful savings within the first six months through labor reduction, fewer errors, and less waste and spoilage, with results varying by operation size.

Enhanced Safety

Tracks materials and personnel to help mitigate risk, supporting consumer safety and regulatory compliance.

Operational Efficiency

Provides real-time visibility and automation, reducing manual processes and improving inventory and production management.

Scalability

Tailored for small to mid-sized producers and multi-site operations, with customizable solutions to fit unique business needs.

Audit-Ready Documentation

Traceability and serialization records are assembled automatically, ready the moment an inspector or auditor asks for them.

Representative Application Patterns

Two ways pharmaceutical management solutions are deployed

BellHawk and MilramX support a range of deployment shapes. These are representative patterns rather than a specific operation's results, described so you can recognize which one resembles your own.

Pattern 1 · Single-Site Pharmaceutical Manufacturer

DSCSA-compliant serialization tied to a single production record

Every lot gets compounded, packaged, and serialized against the same record — no separate spreadsheet tracking which units are already labeled.

A single-site manufacturer deploys BellHawk to log raw materials at receiving, track compounding and packaging in real time, and generate GS1 labels and traceability records automatically. MilramX synchronizes results with the operation's ERP, so quality holds and releases stay consistent no matter who's reviewing them.

What this pattern is intended to improve

Faster traceability record assembly, narrower recall scope if one is ever needed, and less manual reconciliation between the line and quality.

Pattern 2 · Multi-Site Pharmaceutical Distributor

Consistent serialization and traceability across every facility

One dashboard shows quality leadership what's happening at every site, instead of waiting on a status call from each plant manager.

A multi-site manufacturer or distributor deploys BellHawk at each location to capture receiving, compounding, and shipping activity, with mobile devices supporting offline capture where connectivity is limited. MilramX consolidates lot status, inventory, and quality data across sites into dashboards for leadership, without requiring every site to run on the same network.

What this pattern is intended to improve

One consolidated view across sites, faster identification of which location needs support, and consistent serialization wherever product ships from.

These are representative application patterns, not guaranteed outcomes. Actual results depend on operation scope, production volume, network availability, process design, implementation scope, data quality, integrations, procedures, training, and user adoption.

Choose the Right KnarrTek Package

Three ways to run pharmaceutical management software

BellHawk and MilramX are the pharmaceutical management software underneath KnarrTek's product line, delivered as three packaged options. Which one fits depends on how much of your operation runs through the system, how you need to deploy it, and how much automation you want around exceptions.

Cloud

BellHawk Online

Browser-based real-time tracking for inventory, lots, barcode scans, and production activity, without replacing your ERP platform. Receipts, job status, and shipments are visible the moment they're scanned, with no local server to maintain.

Best fit: smaller manufacturers and distributors that want cloud inventory and lot tracking without on-premise infrastructure.
Explore BellHawk Online
On-Premise

WIPtracker

In-facility WMS control covering receiving, compounding, packaging, and secondary operations, plus barcode and RFID data capture — the deeper on-site foundation manufacturers use for full traceability control.

Best fit: manufacturers needing full receiving-to-shipping control, detailed traceability records, and on-premise or offline deployment.
Explore WIPtracker
Connected

SmartOps24x7

ERP integration and smart operations monitoring built around KnarrTek's MilramX agents, adding rules-based alerts, continuous system oversight, and automated data exchange across connected systems and sites.

Best fit: multi-site manufacturers and distributors that need automated exception handling and system-wide synchronization.
Explore SmartOps24x7
Explore KnarrTek's Core Capabilities

Pharmaceutical tracking is one part of a larger record

BellHawk's pharmaceutical management software works alongside the other ways KnarrTek collects data at the point of work. Most deployments combine two or three of these.

Real-Time WIP Tracking

Real-time visibility into your work-in-process operations, across all sites.

WIP tracking

Inventory & Asset Tracking

Accurately track inventory and assets across your facility with barcode and RFID scanning.

Inventory tracking

RFID Inventory System

Streamline and automate inventory tracking with RFID technology where scanning alone is impractical.

RFID tracking

Track & Trace Materials

Track and trace materials from receiving to shipping, the record every transaction posts into.

Materials traceability

Materials Flow & Job Tracking

Monitor material flow and job progress throughout production with real-time inventory tracking.

Job tracking
Not Quite What You're Looking For?

KnarrTek has solutions built around more specific requirements too

This page covers prescription pharmaceutical manufacturing and distribution specifically — DSCSA serialization, GS1 labeling, and drug-specific quality standards. If your operation fits one of these more specific descriptions, these pages go deeper on exactly that.

Medical Devices & Medical Supplies

UDI labeling, Device History Records, and device-focused quality standards built specifically for medical device and supply manufacturers.

Medical traceability solutions

Biotech & Biopharmaceutical Manufacturing

Lot and batch genealogy, sample and reagent tracking, and cGMP-aligned traceability built for biotech, CDMO, and CRO operations.

Biotech traceability solutions

General Laboratory Testing

Sample intake, cold-chain tracking, and chain-of-custody built for analytical, QC, clinical, and environmental testing labs.

Laboratory traceability solutions
Pharmaceutical Management FAQs

Common questions about running an operation on KnarrTek

Practical answers about KnarrTek's pharmaceutical management solutions — BellHawk, MilramX, and what actually changes on the line once an operation starts using them.

Does this cover medical devices or UDI labeling?
No — UDI labeling and Device History Records are medical device requirements, not drug requirements. This page is built around what actually applies to prescription pharmaceuticals: DSCSA serialization, CFR 21 Part 11, and GMP compliance. If you manufacture or distribute medical devices or medical supplies, KnarrTek's Medical Traceability Solutions page covers UDI and device-specific compliance directly.
Is this different from KnarrTek's Biotech Traceability Solutions page?
Yes. This page is built around prescription drug manufacturing and distribution specifically — DSCSA serialization and GS1 labeling for the finished, packaged product. The Biotech Traceability Solutions page goes deeper on upstream biotech and biopharmaceutical manufacturing, lot and batch genealogy, and CDMO/CRO research operations. Some organizations that handle both use both.
What if I only run a single site?
That's fine — everything on this page works for a single site on day one. BellHawk and MilramX deploy the same way whether you're running one facility or coordinating several.
How does DSCSA serialization actually work?
Unit-level serial numbers and GS1-compliant barcodes are generated directly from the same record that tracks the product through production, so the label printed always matches the lot, material, and history data behind it — no separate labeling system to keep in sync.
Does this support GMP compliance?
Yes. BellHawk's traceability and historical data capture support the documentation Good Manufacturing Practices call for. Worth being precise, though: the software supports and documents compliance — certification and enforcement come from FDA inspection and accredited bodies, not from any software.
Does BellHawk work on the line without a live connection?
Yes. Mobile devices support offline store-and-forward capture, so line staff can scan materials, update status, and record results with limited connectivity. Captured data synchronizes automatically once a connection is restored.
Can this integrate with our ERP or accounting system?
Yes. MilramX synchronizes BellHawk's inventory, production, and quality data with ERP, CRM, and other business systems like QuickBooks or Oracle, reducing duplicate data entry and avoiding the cost and disruption of a full system replacement.
What deployment options are available?
Three: browser-based cloud access for operations that want tracking without infrastructure, on-premise for facilities that need full IT control, and multi-site, where data capture stays local while centralized dashboards give leadership visibility across every location.
What's the difference between BellHawk and MilramX?
BellHawk is the layer that captures barcode and RFID scan data on materials, lots, and units at receiving, compounding, packaging, and shipping. MilramX sits on top of that data, adding rules-based automation, alerts, and integration with ERP and other systems. Most operations start with BellHawk for traceability control and add MilramX when they need automated cross-system coordination.
How does this help if a recall does happen?
One-step-forward and one-step-back traceability means you can identify exactly which lots, materials, and finished units are affected by a given issue, instead of pulling an entire production run to be safe. That's the difference between a narrow, targeted recall and a costly, broad one.
Do we have to choose between barcode and RFID?
No. BellHawk reads barcode and RFID data side by side, so an operation can use whichever capture method fits a given workflow — on the same line, without maintaining separate systems.
Can this scale from a single facility to multiple sites?
Yes. BellHawk and MilramX deploy the same way whether you're running one facility or coordinating multiple sites, with multi-site configurations giving leadership a consolidated view without a system overhaul as you grow.
Run a Tighter, More Defensible Traceability Record

Turn manual traceability records into a system that builds them for you

Start with the gap causing you the most exposure — serialization, traceability record assembly, or system integration. KnarrTek's pharmaceutical management solutions team can help map what to track first and how to deploy it, on-premise, in the cloud, or across multiple sites.