Your Operational Backbone for Batch Manufacturing

GMPKit transforms biopharma operations with a software-anchored platform that drives quantifiable quality gains and predictable performance—without added complexity.

Begin seeing measurable results in 90 days

Batch Success

Increase Right-First-Time Manufacturing

Reduce Deviations

Apply Operational Readiness Modeling

Eliminate Backlogs

Clear Documentation & Deviation Backlogs

Minimize Rework

Prevent Material & Documentation Errors

What's at Risk?

Inefficient operations and poor quality puts your business at risk:

Manufacturing inefficiencies cost biopharma companies millions annually in lost batches, compliance issues, and delayed market entry. Without a systematic approach, these challenges compound over time, threatening both operational stability and bottom-line results.

Failed Batches

Each lost batch represents significant financial loss, disrupted supply, and reduced stakeholder trust

Quality Deviations

Recurring deviations increase regulatory risk and operational complexity

Documentation Backlogs

Mounting paperwork delays batch release and creates compliance risks

GMPKit combines LEAN principles with our BatchTrak™ technology to target Cost of Poor Quality (COPQ) metrics.

— Data driven failure prevention.

Your Guide to Operational Excellence

GMPKit combines deep industry expertise, proven methodologies, and purpose-built technology to guide your transformation journey. Our comprehensive approach ensures lasting improvements in quality and efficiency.

Industry Expertise

Deep understanding of biopharma manufacturing, regulatory requirements, and quality systems

ISPE/GAMP5 standards
GMP compliance
Quality systems

Proven Methodology

Systematic approach to quality improvement based on LEAN principles and industry best practices

Process optimization
Risk management
Change control

Implementation Excellence

Structured approach to ensure successful adoption and measurable improvements

90-day results
Role-based training
Ongoing support

Technology Foundation

Purpose-built software platform that drives and sustains operational excellence

Real-time visibility
Automated workflows
System integration

The BatchTrak™ Solution

Our purpose-built platform delivers measurable improvements in quality and efficiency for every role in your organization. See how BatchTrak™ transforms your manufacturing operations.

Site Head - Quality/Manufacturing

Executive Operations Leadership

Operations Manager

Cross-Functional Coordination

Quality Assurance User

Documentation & Compliance

Frontline Leader

Tactical Operations Supervision

Operations Planner

Strategic Planning & Scheduling

IT / Admin

System Integration & Management

Your 90-Day Transformation Plan

Our proven methodology delivers measurable improvements in just 90 days. We combine software, process optimization, and expert guidance to transform your operations with minimal disruption and maximum impact.

Assess your process baseline

We analyze your current batch workflows and identify improvement opportunities

Configure BatchTrak to your flow

Customize dashboards, alerts, and workflows to match how your team actually works

Train your team with our playbook

Role-based training ensures everyone knows how to use the system effectively

Track batch progress in real time

Monitor every batch across all sites with live updates and intelligent 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

Transform Your Operations

See how GMPKit and BatchTrak™ can deliver measurable improvements in your manufacturing process within 90 days.