[intelligent QBD risk assessment tool] Shanghai daoning brings you leanqbd introduction, trial and tutorial

According to the market industry survey

The risk assessment requires approximately 3 Months time

For many busy researchers

3 Months of group meetings are too long

LeanQbd Is a

intelligence QbD Risk assessment tools

Supported by intelligent algorithms

Risk assessment can be carried out in a very short time

Through existing Lean QbD Templates

You can start a risk assessment at any time

Developer Introduction

QbDWorks It's a community of scientists , They are here to share their true QbD Problems and practices .LeanQbD Software is ours QbDWorks The crystallization of success and failure experience shared by the community . 

LeanQbD So that scientists can easily implement QbD ( Quality comes from design ).

Quality comes from design Is a systematic development method , It starts with a predetermined goal , Emphasize product and process understanding and process control , Based on sound scientific and quality risk management .

LeanQbD A lot Biotechnology 、 Pharmacy 、 Medical apparatus and instruments Excellent choice for related enterprises and organizations , So far ,Merck、Lilly、Medtronic、Dr. Reddy's、Sun Pharma and FDA And other famous companies are using LeanQbD To conduct a risk assessment .

Product function

1、 The product contains

• QbD Risk assessment software

• One QTPP-CQA-CPP Templates ： Tablet templates for immediate release

• One QTPP-CQA-CPP Templates ： Of biological agents aMab Templates （ Available for purchase ）

• More templates and product template customization

These templates are based on FDA And industry case studies , You can easily edit your project . These templates will help you save meeting time to collect candidates QTPP、CQA and CPP.

2、QbD Risk assessment function

• Simplify the overly complex risk assessment process

• Eliminate non value added meetings

• Get the support of scientists by saving their time and asking the right questions .

• Easy promotion QbD Meetings and reduced preparation time

• Visually share and communicate risk assessment results

• It is easy to update the risk index throughout the development lifecycle .

• Use the practical risk assessment template to save time .

• …… And lead your QbD The plan was successful ”

Product advantage

1、 Easy to use and simplify processes

• As QbD The first step , Risk assessment must be simple and easy for your team .

• Use LeanQbD intuitive , Because it was designed by scientists , It is also designed for scientists .

• Easily assign and track risks , Connect QTPP-CQA-CPP/CMA.

• Use smart dashboards to visualize risk parameters .

2、 Save time and automation

• Delay 1 God = Loss 100 Thousands of dollars

• save 3 Months of development time .

• Use FDA In the case study QbD Risk assessment templates save time .

• Automate the generation of time-consuming documents 、 Reports and charts .

• Your colleagues will recognize you for accelerating QbD The contribution of the development time of the project .

• Focus only on the necessary design space work - More important work .

3、 cooperation & Remote work

• You and your team can be in QbD Real time collaboration on projects .

• Easy to remotely manage projects or customers .

• eliminate 70% Unnecessary meetings .

• Reduce 70% And improve productivity and satisfaction ！

Product characteristics

01、QbD risk assessment

QbD Risk assessment yes Quality-by-Design Pillars of the plan .

LeanQbD It's intelligent QbD Risk assessment tools , You can relate process parameters to your patient .

Use correlation matrix and FMECA To calculate the quality target product profile 、 Key quality attributes 、 Risks of key process parameters and key material properties , The software runs in the background , So you can focus on the important things - Connecting science to patients .

02、LeanQbD working principle

step 1— Input parameters ：

Use Lean QbD Templates , You can start now , Skip most of the tedious initial setup you're used to . Customize according to your needs QTPP/CQA/CPP Input . We also provide import services , Help you from excel Or other data format migration .

step 2：— Allocate risk ：

Our dedicated risk assessment grid and wizards make it simple , Decoupling the time and function of scientists . In each step , Record And store relevant metadata and file attachments as needed .

step 3— The key parameters ：

Comprehensive charts and reports （ Include (C)PP And basic principles of user-defined input ） Make it easy to identify patient risks . Our detailed risk assessment documentation reports help you prepare faster than ever FDA Submit .