Insert Required Fields in the Product Defect Notice and eSign it in minutes

Aug 6th, 2022
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How to Insert Required Fields in the Product Defect Notice

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the Health Sciences authority or HSE as a post market surveillance program to monitor the quality safety and efficacy of their building products in Singapore one component of this program is the management of product defects as the product registrant manufacturer importer or supply of therapeutic product you are required to do the following to report product defects related to your therapeutic product to HSA or to notify us if you are recalling any product before initiating the recall process this video aims to provide you with information regarding the requirements and the processes for further defect reporting and product recalls further defects can arise during the manufacturing the storage and the handling of therapeutic products it is important that you report these defects arising from during these processes especially if they can affect a product safety quality and efficacy this can help identify issues that may affect the users and ensure measures are taken to protect public he

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A defect should be clearly defined, that is , the defects logged are easily comprehensible. A defect report should therefore contain the following fields - title, summary, system configuration, steps to reproduce the defect , expected results, and also brief notes having content about essentials.
A defect report contains the following fields at minimum: Project or system name; The name of the (test) project or of the system under test. Unique identification of the defect; A unique identity, usually in the form of a (serial) number of the defect report, for purposes of management and tracking progress.
Therefore, Requirement baselining is not a part of defect management process.
A good bug description is not only about the problem itself. It should also include information about actual results vs expected results. Writing down what are the intended actions will help to identify the source of the problem and decide on what exactly needs to be fixed.

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