Mandatory documents for SaMD to develop QMS
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You do not need any sterilization documents of course. Considering the installation, if it is done by the user without any record for that, then you also do not need installation procedure and documents.
In your case, the service procedure will cover solving bugs and similar problems.
All other documentation is necessary for you, but you need to adjust it to your process. For example, you need Production and service procedure because here you will describe how you will program your software, who is involved in it, what kind of test you will do, how you will solve bugs, and so on.
You also need Purchasing procedure because you need to define specifications for programs for software programming and licenses. Also, if you use cloud service or have a server at your place, then you need to order some specific elements for the server.
You need a warehouse procedure if you use some computers, motherboards, hardware, and so on. If you use a server room then it is necessary for the server to be in an appropriate environment (temperature and humidity). In that case, you need to monitor the temperature and humidity in that room.
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Sep 20, 2021