ABSTRACT
Risk management is the starting point of every project and involves a systematic application of policies, procedures, and practices to the analysis, evaluation, and control of risks. It is a key component of quality management systems. Software development is one of the most risk prone management challenges. Risk factors are usually present that can negatively impact the development process and, if neglected, can lead to project failure. Strategies for mitigation or applying controls of the identified risks may include modifying the process or system design, modification of project approach or structure, modifying the validation and testing approach, adding new features, apply external procedures, and/or more detailed rigorous specification and verifications. Risk management should be applied throughout the lifecycle of the computerised system taking into account patient safety, data integrity and product quality.
