Service Description

Top management is responsible for the IMPLEMENTATION and OPERATION of an effective quality system that ensures

(1) compliance with established regulatory requirements,
(2) the implementation of the quality policy, the achievement of the set quality objectives, as well as the fact that
(3) Roles, responsibilities and powers are DEFINED, COMMUNICATED to staff and RESPECTED throughout the organization and/or its separate divisions (2.4 Parts 1 GMP; 2.1 (b) and 2.6 Parts 3 GMP).

This is achieved, among other things, by conducting an analysis by management, which is (should be) one of the main elements of the quality system.

The absence of an analysis is a CRITICAL discrepancy, since it violates the DIRECT and very IMPORTANT requirement that such an analysis should be carried out (1.6 of Part 1 of GMP; 1.7 of Part 3 of GMP).

This is the same story as the fact that parents are responsible for the upbringing of their child, as well as for the fact that the roles, responsibilities and powers of all those who interact with her are defined, brought to their attention and strictly observed. At the same time, parents, with the help of periodic analysis of the achieved results, ensure constant compliance and effectiveness of the chosen parenting model, orientation, amount of training and correction of the baby's behavior. It is the timeliness and depth of such an analysis that determines the success, career and mental balance of their child.