Quality by Design Software
Lean QbD
QbD Software - for the Smart Scientists
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.
QbD Risk Assessment | Design Space | Knowledge Management
Pharma 4.0 | KASA: Knowledge Assisted Structured Application
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 QbD For 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.
Recommended
"A very well received risk software, a QbD instructive for beginners with showing how to link QbD terms as QTTP, CQA and CPP. I can wholeheartedly recommend it for anyone looking for a well coordinated guiding QbD software."
- M.S. - Drogsan Pharmaceuticals
Proven For Over 10 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