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  • hm243 replied to the topic How to write SOP ? Which SOPs are for cGMP ? in the forum Device Documentation 7 years, 10 months ago

    The SOP documents are important in the process of Design Transfer in ensuring the device will be able to be created following a routine. All parts of the SOP play a significant role in the document. I agree with you that the procedures are important because they ensure that the purpose is fulfilled. Also, the procedure includes the steps necessary for the work to be completed. I do feel that the responsibilities section is also very important. The responsibility distribution needs to be done to make sure that each part is completed to best of their ability. If the responsibilities are not assigned properly, then the work will not be completed properly.