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Software used for the support of processes in quality management systems (QMS) must be validated to confirm that the software fulfills the intended purpose. Important to understand is, that the validation must be conducted on the basis of the application process and in the IT environment of the software operator.
Easy software validation
In the QMS standard ISO 13485 for medical device companies it is highlighted, that the specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software. This risk-based approach is different in the medical technology industry compared with other industries: Risks related to patient safety, loss or degradation of performance as well as risk for regulatory noncompliance must be evaluated.
- What are general requirements for software validation, which documents must be created?
- What is a risk-based approach, particularly for manufacturers in the medical technology industry?
- Different software types and software implementation projects: What is the impact on the validation documentation?
- What is the role of a software vendor? How can the validation be supported by external documentation and resources?
- How can the effort for re-validation be reduced?