当前位置:网站首页>[intelligent QBD risk assessment tool] Shanghai daoning brings you leanqbd introduction, trial and tutorial
[intelligent QBD risk assessment tool] Shanghai daoning brings you leanqbd introduction, trial and tutorial
2022-07-01 22:20:00 【51component technical exchange】
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 .
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