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What is an architecture design chart?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

This document is typically a flowchart or similar depiction of the relationships among the major functional units in the Software Device, including relationships to hardware and to data flows such as networking. It is usually not necessary to include every function call and module in this document; however, there should be sufficient information to allow for review of the organization of the software relative to the functionality and to the intended use of the Software Device. For Moderate and Major Level of Concern devices, detailed information such as state diagrams may be useful to clearly depict the relationships among the software functional units. If the Architecture Design Chart is included in another document such as the SRS then you should include in your submission a statement to that effect and a reference to the location of the Architecture Design Chart in the submission.  

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