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).