BizzMine CAPA management helps you to continually improve the effectiveness of your quality management system.
Start and link CAPA’s from within any other BizzMine process
A CAPA can be initiated as an independent registration or can be launched directly from another process like a customer complaint, an internal audit, a deviation, a customer feedback, a Post Market Surveillance...
Links are maintained so users can overview the whole process and can see what triggered the CAPA.
With the BizzMine workflow module the CAPA and MoC processes have been made paperless and are compliant to the requirements of 21 CFR Part 11.
– Carbogen AMCIS
Define an impact analysis and a recurrence check.
Identify, analyze and track all possible root causes.
Execute detailed risk assessments and determine what actions need to be taken.
It is not enough to do your best; you must know WHAT to do and THEN do your best.
– W. Edwards Deming
Implement and document the result of the CAPA.
Register all relevant data in the customizable CAPA form, attach implementation reports or pictures.
Check & Act
Measure and validate the effectiveness of the CAPA.
If the effectiveness is below satisfaction, the loopback mechanism in the CAPA process will allow you to respond and take action.
Monitor your CAPA data through your dashboards
Since you can work with categories, you can easily generate statistics of the root causes.
The dashboards are easy and smooth to navigate throughout the information and can be customized to present the most valuable and useful data.
This allows each group of users to see the overview lists, Pareto graphs, and Trend analyses they need to get their job done and meet their goals.
BizzMine CAPA Management works on all devices, anytime, everywhere!
And is available in the Cloud or On-Premises.