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
Increase Right-First-Time Manufacturing
Apply Operational Readiness Modeling
Clear Documentation & Deviation Backlogs
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
Proven Methodology
Systematic approach to quality improvement based on LEAN principles and industry best practices
Implementation Excellence
Structured approach to ensure successful adoption and measurable improvements
Technology Foundation
Purpose-built software platform that drives and sustains operational excellence
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
Our reliability checklists improved batch success rates from 74-93% at a large scale antibody production facility
Our structured deviation investigation approach reduced backlog of batch deviations at a cell therapy facility
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.