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  • hm243 replied to the topic Simulation 1: Faulty Quality System in the forum Device Documentation 7 years, 10 months ago

    It does seem a bit tedious to repeatedly update the document when a new revision is made because then multiple documents will have to be updated as well. However, I do feel that it is very important and necessary that this process is done. If the revised document is not recorded, then the current documents will not be suitable for the revision. For example, when the SPEC document was revised, it is important that the work instructions are revised to reference the new revised document. If not, the work instructions will not be fitting for the new document and cannot be used properly. As you mentioned, if the documents are not updated, then they will become outdated, which puts the company at more risk for their product. As repetitive as it may seem, this plays a huge role in ensuring the correct protocols are met.