Quality by Design Software

Lean QbD

QbD Software - for the Smart Scientists

QbD Risk Assessment | Design Space | Knowledge Management

Pharma 4.0 | KASA: Knowledge Assisted Structured Application

What is Lean QbD™ ?

Find out why the FDA, Merck, Medtronic, and many others are using LeanQbD

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Easy To Use & Streamlined

As the first step in QbD, risk assessment must be simple and painless for your team.
Using LeanQbD is intuitive because it was designed by and for the scientists.
Easily assign and track risk, connecting QTPP-CQA-CPP/CMA.
Visualize risk parameters with Smart Dashboard.

Save Time & Automate

1 day delayed = $1M lost
Save 3 months of development time.
Save time with QbD risk assessment templates from FDA case studies.
Automate time-consuming Documentation, Reports, and Charts.
Your colleagues will recognize your contribution for accelerating development time on QbD projects.
Focus only on necessary design space work - where it matters the most.

Collaborate &

Work Remotely

You and your team can collaborate real-time on QbD projects.
Easy to manage projects or clients working remotely.
Eliminates 70% of unnecessary meetings.
Cut 70% of your meetings and increase productivity and satisfaction!

What is LeanQbD?

A Smart QbD Risk Assessment Tool

Industry survey reveals that risk assessments take about 3 months.
3 MONTHS? As busy scientists, we can't afford 3 months of group meetings.

Meet Lean QbD - Risk Assessment in a fraction of the time
Powered by the intelligent algorithm and infused with best practices

Turn QbD skeptics into supporters. And with Lean QbD™ Templates, you can begin today.

Why LeanQbD?

Risk Assessment is the Most Important Step in QbD

QbD risk assessment is the backbone of a Quality-by-Design initiative

Lean QbD is the smartest QbD Risk Assessment tool that connects process parameters to your patients.

Using Correlation Matrix and FMECA to calculate the risk of Quality Target Product Profile, Critical Quality Attributes, Critical Process Parameters and Critical Material Attributes, the software works in the background so you can focus on what's important - connecting science to patients.

A Leader In Cloud QbD Software For over 7 Years

Our Background

"As a QbD facilitator, I could not sit through another long Risk Assessment meeting. Then I remembered, during my PhD research at Stanford University – I conducted more than 50 FMEA sessions for Fortune 500 companies and learned why it fails when used in the wrong context. I wrote an article and shared my learning on this.

Instantly, over a hundred scientists liked, commented, and shared my article. So I knew I wasn’t alone and many of us were suffering from a tool mismatch problem.

So I decided to do something about it for our QbD community..."

- Sun Kim (QbD Expert)

LeanQbD Templates

There's no need to Re-invent the wheel. Shortcut the learning curve. Our process development scientists crafted LeanQbD Templates based on industry and FDA case studies. If you'd like a custom template for your product, please contact us.

Simplicity

The best Practices of QbD Risk Assessment have been designed into the software. No Learning Curve.

"A QbD Scientist should not have to be a computer scientist to use Risk Assessment software!"

Don't work harder, work smarter.

Discover why leading companies perform

their Risk Assessment using LeanQbD

Proven with successful submissions
Secure Cloud Solution
Ready-To-Use Templates
Team Collaboration
Dynamic Charts
Comprehensive Reports
Create Customizable Report Templates

Upload Files and notes - all information in one place
Simple Input, Comprehensive Output
Automatic, Secure Cloud Backups
On-Premise Installation Available

Learn More...

About Us

Pharmaceutical QbD

QbDWorks is a community of scientists in the benches and trenches who share their real QbD struggles and best practices.

Lean QbD software is a result of our QbDWorks community sharing what works and what doesn't.

Lean QbD enables scientists to easily implement Quality by Design.

Need a hand? If you'd like customized help, we provide consulting services. Please contact us.If you have any further questions, please feel free to ask!

Your QbD Success is Our Mission

Proven For Over 7 Years

"I have completed utilizing your software as part of a project and it has been great! My experience has been very positive."

T. E - Merck

Trusted Worldwide

Who uses Lean QbD?

Companies like Merck, Lilly, Medtronic, Dr. Reddy's, Sun Pharma, and the FDA among many others are using LeanQbd. We are constantly improving Lean QbD based on feedback from the regulatory agencies and users.