Quality Risk Management

HOW TO COMPLY WITH ICH Q9 STANDARDS?

According to Eu GMP Part III (ICH Q9), Quality Risk Management is a systematic approach to evaluate, control, communicate and review risks linked to products’ safety and effectiveness.

In last year most competitive and innovative Companies are paying specific attention to QRM and methods and tools that help defining risks in a objective way and improving compliance with GMP.

That’s why PRAGMA® QRM package was born. Designed with the cooperation of the most relevant QRM experts, PRAGMA® QRM is perfectly compliant with ICH Q9 and FDA CFR 21 part 11 (Audit Trail, Electronic Records and Signatures).

 

Read more about PRAGMA® QRM

ABOUT PRAGMA®

0
COMPUTERISED WORKFLOWS
0
USERS
0
PLANTS WORLDWIDE

DEPARTMENTS ALREADY MANAGED WITH PRAGMA®



PRAGMA Workflow Manager

How will you improve your QRM workflows? Fill in the form to learn more.