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Hi everyone!
need your advice.
I represent a software outsourcing company and we are responsible for creation software medical device for our partner. We use an iterative approach to the development. That means that we identified the product features and take them one-by-one to define how they should be implemented. When we complete analysis of a feature (or a set of them), a review is conducted. This review involves representatives of all the involved functions, as well as an independent reviewers, and have all other attributes of a design review required by Quality System Regulations part 820. As a result we create a meeting minutes where participants and decisions made are documented, but we do not apply any digital signatures on them.
And my question is: will it be acceptable from the FDA stand point that we keep collecting the meeting minutes in the way we are doing it right now and then create a report that summarize all the reviews, will include all the meeting minutes as a attachment and this report only with the attachment will be approved electronically in the system compliant with Part 11?
How do you collect such records?
Thanks a lot in advance!
need your advice.
I represent a software outsourcing company and we are responsible for creation software medical device for our partner. We use an iterative approach to the development. That means that we identified the product features and take them one-by-one to define how they should be implemented. When we complete analysis of a feature (or a set of them), a review is conducted. This review involves representatives of all the involved functions, as well as an independent reviewers, and have all other attributes of a design review required by Quality System Regulations part 820. As a result we create a meeting minutes where participants and decisions made are documented, but we do not apply any digital signatures on them.
And my question is: will it be acceptable from the FDA stand point that we keep collecting the meeting minutes in the way we are doing it right now and then create a report that summarize all the reviews, will include all the meeting minutes as a attachment and this report only with the attachment will be approved electronically in the system compliant with Part 11?
How do you collect such records?
Thanks a lot in advance!