INEX carries out the whole range of works on qualification of design documentation (DQ - Design Qualification).

The cleanroom validation process begins with the qualification of the design documentation. The purpose of this validation phase is to prove that the design of the cleanroom is appropriate for its intended purpose. The design qualification is a confirmation that all the conditions set out in GOST R 56640-2015 Cleanrooms were met during the development of design documentation. Design and installation. General requirements "and applied in the construction of clean rooms. Obtaining the DQ protocol is a prerequisite for starting the procedure for obtaining the IQ protocol (Installation Quialification).

Project qualification (DQ) is carried out with the aim of:

- analysis of the concept and the main idea of the project;

- assessments for compliance with GMP requirements;

- determining the feasibility of the subsequent stages of qualification and validation;

- reducing the level of significance of risks for subsequent stages of project implementation (in accordance with the risk management system and risk analysis in the validation process).

To carry out these tasks on a case-by-case basis, INEX creates an expert team working with the customer from the moment the technical assignment is received. A design qualification (DQ) must be completed prior to the commencement of construction of a projected facility. The first condition for its effective implementation is the presence of a well-defined User Requirements Specification (URS). At this stage, the customer is also assisted by highly qualified specialists of INEX Company.

During the project qualification (DQ) process, a Qualification protocol is drawn up, which reflects all the results of the qualification. The protocols contain the entire program of checks and the procedure for formalizing the results obtained in this case. As a result of the analysis of the data obtained, a project qualification (DQ) report is drawn up, after which it is possible to proceed to the next stage - Installation Quialification, IQ.