Validation of computerized systems in the field of medical devices
Provide documented and justified evidence of compliance with general safety and operational requirements, as well as other legal requirements, those relating to quality and risk management.
Demands on computerized systems
Products incorporating computerized systems, including computerized systems, or computerized systems which are products in themselves, shall be designed to ensure repeatability, reliability, and operation in accordance with the intended use. Appropriate measures shall be taken to eliminate or reduce as far as possible any consequent risks or deterioration in performance.
Computerized systems shall be developed and manufactured on the basis of the state of the art, taking into account the principles of the development life cycle, risk management, including information security, validation, and verification.
Focus on processes for quality management
For an organization to function effectively, it has to identify and manage numerous interrelated processes. The application of a system of processes within an organization, along with the identification and interrelationships of these processes, as well as their management to produce the desired outcome, can be referred to as a “process approach“.
When used within a quality management system, such an approach highlights the importance of:
- Understanding and meeting the requirements.
- The consideration of the processes in terms of added value
- Obtaining results from the operation and efficiency of the processes.
- The improvement of the processes based on objective measurement.
Life cycle concept
The life cycle of the computerized system is the conceptual structure from the definition of its requirements to its dissemination for manufacturing, which:
- Identifies the process, activities and tasks involved in the development of a software product.
- Describes the sequence and independence between activities and tasks.
- Identifies the milestones at which the completion of specified deliverables are verified.
The main stages of the life cycle are the development process and its maintenance.
The manufacturer must establish, document and maintain a continuous process throughout the life cycle to identify the hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls.