Drive Clarity
Increase Success

BatchTrak™ is a digital platform built on LEAN principles, giving pharmaceutical and biotech manufacturers real-time visibility into every batch. By replacing spreadsheets and manual trackers, BatchTrak™ eliminates guesswork, reduces waste, and drives continuous improvement through structured, role-based workflows.

What is BatchTrak™?

Think of it as a digital command center for your production floor

Every manufacturing batch goes through multiple steps—manufacturing, document review, deviation investigation, and testing. BatchTrak™ tracks each step in real-time, so you always know:

  • Which batches are running and which are delayed
  • What's causing bottlenecks in your process
  • When batches will be ready for release
  • Who's responsible for each step
BatchTrak™

The Bottom Line

BatchTrak™ replaces the chaos of spreadsheets, emails, and phone calls with one clear system that everyone can see and use. Your team spends less time hunting for information and more time moving the KPIs that matter:

Increasing success rate

Decreasing deviations

Adhering to schedule

On-time disposition

Why Most Batch Operations Break Down

Even the best teams struggle when their systems can't keep up with the complexity of scaling up batch manufacturing. Critical KPIs suffer—more lost batches, longer review cycles, and delayed dispositions—while business outcomes fall short.

Manual systems don't scale

Spreadsheets and paper trails break down as you grow

Visibility gaps delay decisions

You can't manage what you can't see in real-time

Deviations pile up, root causes vanish

Problems compound when tracking is reactive, not proactive

Everything You Need in One Platform

BatchTrak™ combines real-time visibility, intelligent automation, and ISPE/GAMP5 commissioned standards alignment to support biopharma manufacturers who require both operational efficiency and regulatory confidence.

Real-Time Batch Tracking

Monitor every batch across all sites with live status updates, automated alerts, and comprehensive audit trails.

Workflow Automation

Improve batch reliability with configurable workflows that keep teams aligned, accountable, and on track—without overhauling your existing systems.

Intelligent Analytics

Turn data into insights with AI-enabled analytics that identify trends, predict issues, and recommend actions.

GMPKit fixes this by combining LEAN principles with BatchTrak™ technology

BatchTrak™ combines real-time visibility, intelligent automation, and ISPE/GAMP5 commissioned standards alignment to support biopharma manufacturers who require both operational efficiency and regulatory confidence.

Real-Time Batch Tracking

Monitor every batch across all sites with live status updates, automated alerts, and comprehensive audit trails.

Workflow Automation

Improve batch reliability with configurable workflows that keep teams aligned, accountable, and on track—without overhauling your existing systems.

Intelligent Analytics

Turn data into insights with AI-enabled analytics that identify trends, predict issues, and recommend actions.

Everything You Need in One Platform

BatchTrak™ isn't just software—it's a complete operational system designed to eliminate waste, reduce risk, and accelerate results.

Operational Visibility & Control

Know exactly what's happening—in every batch, at every site, in real time.

Unified dashboard for multi-site batch tracking
Intelligent alerts for escalations and delays
Role-based views for QA, Ops, and Leadership
Catch issues before they become escalations

Connected, Configurable Workflows

Integrate with your systems and streamline batch execution.

Open APIs for ERP, MES, LIMS, and more
Workflows aligned to your SOPs and tech stack
Clear accountability across departments
Scales from single-site to enterprise rollout

Built-In Intelligence & Team Enablement

Go beyond tracking—equip your team to lead and improve.

AI-enabled analytics
LEAN + Theory of Constraints foundations
Deviation prevention and decision-support tools
Role-based onboarding and training

Designed to Move the Metrics That Matter

BatchTrak™ delivers real results—on the floor, across departments, and at the leadership level.

Batch Success Rate

Increase first-pass success rates and reduce batch failures through proactive monitoring and prevention.

Deviation Rate

Minimise deviations with early detection, structured workflows, and root-cause prevention.

Adherence to Production Schedule

Keep batches on track with real-time schedule visibility and proactive bottleneck management.

Adherence to Disposition Schedule

Accelerate lot release with streamlined disposition workflows and automated status tracking.

5S Housekeeping

Maintain operational discipline with built-in 5S tracking and continuous-improvement workflows.

Record Review Performance

Streamline batch, analytical, and execution record reviews with automated tracking and alerts.

Proven Results

GMPKit frameworks were developed by biopharma industry veterans with decades of experience in batch manufacturing and quality operations.

Our methodologies have been applied across both innovator and CDMO organizations, supporting everything from large-scale antibody production to fast-moving cell therapy startups.

Select Outcomes

93%
Increased Success Rate

Our reliability checklists improved batch success rates from 74-93% at a large scale antibody production facility

90%
Deviation Backlog Reduction

Our structured deviation investigation approach reduced backlog of batch deviations at a cell therapy facility

3x
Batch Throughput Increase

Our approach to scale and leadership development increased a cell therapy start up's batch throughput in 18 months

See BatchTrak in Action

Experience how BatchTrak™ can transform your batch operations with a personalized demonstration tailored to your use case.