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1. THE COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEM MANUAL
2. THE COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEM SOFTWARE

THE COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEM SOFTWARE

(3.4) The information of the quality system and assessment of suppliers or developers of software and installed computerized systems shall be available for provision to persons conducting audits at their request. (3.3) Documents provided with commercial software products that are ready for use shall be studied by authorized employees of the manufacturer for their conformity with the manufacturer’s requirements.ġ0. The necessity to assess the supplier shall be based on the risk assessment.ĩ. (3.2) The expertise and reliability of suppliers shall be the key conditions for the selection of a supplier of a software product or services. It is recommended to indicate in these contracts that third parties shall duly fulfil their obligations.Ĩ. (3.1) If third parties (namely, suppliers, service providers) are employed to deliver, install, set up, configure, integrate, validate, provide maintenance services (including by remote access), modify or maintain computerized systems, provide services connected with them or to process data, the manufacturer and the said third parties shall sign contracts. All staff members shall have appropriate qualification, access level and definite powers in order to perform assigned duties. It is necessary to support close collaboration among all significant staff members engaged in this process, such as the owner of the process, the owner of the system, authorized persons and the technical staff. Within the framework of the risk management system decisions on the scope of validation tests and data consistency tests shall be based on well-grounded and documented risk assessment of the computerized system. Risk management shall be used during the life cycle of the computerized system to ensure the safety of patients, data consistency and product quality. GENERAL REQUIREMENTS Risk management (1)ĥ. Total risks of the process shall not increase.

THE COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEM MANUAL

If a computerized system replaces manual control, it shall not result in a decreased quality of products, process control or quality control. Use of a computerized system shall be validated, the IT infrastructure shall be subject to qualification.Ĥ. A computerized system is a combination of software and hardware components that together fulfil certain functions.ģ. This Attachment shall apply to all types of computerized systems used in activities governed by the requirements of these Rules.Ģ. 1.4.6 Change and configuration management (10)ġ.1.2.3 Suppliers and service providers (3).