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pst8 replied to the topic "Minutes for meetings" – 5 years, 12 months ago
Like others have said, meeting minutes are extremely important. They are they to track the progress of the project and what occurred during the meeting. If someone forgot a topic discussed in a very long meeting, the meeting minutes are… Read more»
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pst8 replied to the topic "Making up tests for design verification and validation" – 5 years, 12 months ago
As others have stated, the FDA does not give mandatory tests that need to be done. However, they do enforce that design verification and validation very very strictly (as well as process/software etc.). Here, verification is done to show that… Read more»
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pst8 replied to the topic "Design Transfer" – 5 years, 12 months ago
Actually, lots of larger companies also outsource certain products (or parts of products). For example, say a larger company designs a product and one of the components is patented and owned by another company. Here, the large company cannot make… Read more»
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pst8 replied to the topic Minutes for meetings in the forum Introduction to Design Controls 8 years, 6 months ago
Like others have said, meeting minutes are extremely important. They are they to track the progress of the project and what occurred during the meeting. If someone forgot a topic discussed in a very long meeting, the meeting minutes are there as a reminder. If a higher up needs to see the project progress, the meeting minutes are there to show the…[Read more]
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pst8 replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls 8 years, 6 months ago
As others have stated, the FDA does not give mandatory tests that need to be done. However, they do enforce that design verification and validation very very strictly (as well as process/software etc.). Here, verification is done to show that the product meets its design specification (it is what its supposed to be) whereas validation is done to…[Read more]
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pst8 replied to the topic Design Transfer in the forum Introduction to Design Controls 8 years, 6 months ago
Actually, lots of larger companies also outsource certain products (or parts of products). For example, say a larger company designs a product and one of the components is patented and owned by another company. Here, the large company cannot make the component due to copyright laws and will not be able to complete the final product. So, they make…[Read more]