Development of documentation for validation and qualification:
º Specification of user requirements (URS);
º Functional specification (FS);
º Hardware design specification (HDS);
º Project specification of software tools (SDS);
º Validation master plan (VMP), risk analysis, protocols and reports
Computerized systems (monitoring systems of production/laboratory environment parameters:
º BMS, EMS (climate monitoring systems, etc.);
º Transportation processes (cold chain);
º Methods of testing (analytical, microbiological, etc.));
º Cleaning process;
º Production process
º Full cycle of registration of medical devices (preparation of documents, necessary tests, dossier maintenance in Roszdravnadzor);
º Changes to The registration certificate and registration dossier;
º Certification and Declaration of products;
º Obtaining a license for the production of medical devices;
º Obtaining a document confirming the purpose of raw materials and components of medical products;
º Development of Technical and Operational documentation
º Periodic monitoring of critical parameters of clean rooms, local clean areas, warehouses, gas production, storage and distribution systems, equipment;
º An independent audit during the commissioning, FAT / SAT testing;
º The development of the advanced documentation for commissioning works for the pharmaceutical / medical manufacturing / laboratory enterprises
º Project documentation for production, laboratory and warehouse facilities;
º Heating, ventilation and air conditioning (HVAC) systems, clean rooms and operating rooms;
º Local clean areas (biological safety boxes, Insulators, Barrier systems of open and closed types: O / C-RABs, Active / passive transfer Windows, etc.);
º Warehouses and cold stores;
º Technological environments (systems for production, storage and distribution of gases, purified water, water for injection, pure steam);
º Production, laboratory, climatic equipment
º Modernization of production sites, processes and systems using basic methods (PHA, FMEA, FMECA, HAACP);
º Professional translation of documentation for pharmaceutical / medical manufacturing / laboratory enterprises from English / into English
