Quality by Design Software
Lean QbD

QbD RISK ASSESSMENT SOFTWARE
FOR THE SMART SCIENTISTS

Finish QbD Risk Assessment With Ease.
Visualize - "Which Process Parameters Affect Our Patients"

Find out why Merck, Medimmune, Medtronic are using Lean QbD™

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What is Lean QbD™ ?

SMART QbD RISK ASSESSMENT TOOL FOR THE DEVELOPMENT SCIENTISTS

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 3 Days 
Powered by our software and infused with proven best practices

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

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"LeanQbD approach ... Links QbD terms as QTPP, CQA and CPP. 
I wholeheartedly recommend it for anyone looking for a well-coordinated, guiding QbD Software."
Mehtap Saydam - Process Development Scientist, Sanovel

COMPANIES WHO TRUST US

Peek Inside

SIMPLE and EASY with BETTER RESULTS

Best Practices of QbD Risk Assessment has been designed into the software.
No Learning Curve.
New Video Coming Soon!

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Increase QbD Success Rate

How Lean QbD™ Works to Your QbD Success

Don't work harder. Work smarter. 

  • EASY  TO  USE

    START RIGHT

    As the first step in QbD, risk assessment must be simple and painless for your team. Easy-to-Use guide will cut the learning curve at the development stage. Get the "Wow" from your QbD team. 

  • CONNECT QTPP - CQA - CPP

    LINK QTPP-CQA-CPP-CMA

    Lean QbD™ is the only tool that enables you to quantitatively link your process parameters to what matters to the patient. Scientifically connect QTPP-CQA-CPP-CMA. No more guessing games that comes from a typical FMEA session. 

  • COLLABORATE

    ACTIVATE TEAM = EFFICIENT

    Eliminate painful group meetings (those where most folks have to sit through arguing over 3 vs 4). You can assign work to your team so everyone is involved. Then meet to discuss the control strategy. This will cut 70 % of meetings  - and increase everyone's productivy and happiness.

  • VISUAL CONTROL STRATEGY

    PRACTICAL & VISUAL 
    CONTROL STRATEGY

    Visualize risk parameters with HD Control Strategy™. Have practical discussions that lead to prioritizing the design space projects - where it matters at the development stage. Scientists will love you for this feature alone.

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Why 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 only QbD Risk Assessment tool that connects process parameters to your patients.

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

 

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Lean QbD™ Templates

Jump Start With LeanQbD Templates

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.

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I'm Glad You Asked!

Any Questions Before Using Lean QbD™?

If you are asking the questions below, you are on the right track.

  •  Does Lean QbD™ follow the ICH Q8 (R2)  and ICH Q9 Guidelines?
     
    Yes. Lean QbD™ is in full compliance with ICH Q8 (R2) and ICH Q9, Q10. In fact, it is the only tool designed with the ICH guidelines in mind.
  •  Who uses Lean QbD™?
     
    Companies like Merck, Medimmune, Lilly, Medtronic,  Dr. Reddy's and many others are using this software. We are constantly improving the product based on users' feedback and field testing. 
  •  How easy is it to use Lean QbD™?

    You can use it right away. We are constantly improving the usuability. It is already self-explanatory so it doesn’t need a manual. A Help document is provided when you download the product.

    Need a hand? If you'd like a customized template, we provide consulting service for a fee. Please contact us.

    If you have any further questions, please feel free to ask!

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Click the button below to try LeanQbD and see how Lean QbD™ will help your QbD projects succeed and turn skeptics into believers.

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