Modern medical device regulations are putting more and more emphasis on the management of software tools. These tools are software packages that are not part of the medical devices themselves, but support the device during its development lifecycle and quality management.
Confluence Cloud is one such software tool that companies can use for their document management system that needs to be validated. But what exactly should you validate in your Confluence Cloud?
For more on which software tools need to be validated, requirements for validation and the best practices – please check out the white paper on validation.
The features to be validated in a software tool are determined through the analysis of company’s intended use of the tool and its risk assessment. But there are certain key items that must always be included.
These features are the ones that directly affect data integrity and security, and that are explicitly called out in the medical device regulations such as FDA 21 CFR 11.
For your Confluence Cloud, these functionalities are the following:
Other items to consider, according to the specific use in each Company:
To summarise the activities you should perform to validate your Confluence Cloud:
Marion Lepmets _SoftComply_
CEO
SoftComply
Munich, Dublin, Tallinn
3 accepted answers
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