Gamp category 411/4/2023 Through the principles and methodologies suggested here, this guide will help the organization to ensure that computer systems prove their fitness for intended use, meet the good practices of the industry in an efficient manner, provide practical guidance to facilitate the interpretation of regulatory requirements, with a language and terminology easy to understand and interpret, clarify the roles and responsibilities of each of those involved in the validation of computerized systems.įinally, this guide is designed for understanding the principles of validation of computerized systems by the most diverse personnel, both those who occupy this knowledge as part of their daily work and those who at some point will be involved in the effort to validate a system without any prior knowledge of Good Practices, validation or IT computer terminology, thus becomes a valuable tool for both and for anyone who wants to train others in basic and logical principles of work on Computer Systems Validation.Ĭurrently, the Health Industries such as pharmaceuticals (human and veterinary), pharmochemical, (APIs and excipients), biologics, biotechnology, blood products, and medical devices, are required to establish a validation program to demonstrate that any procedure, process, equipment, material, activity or system actually leads to the expected results.
0 Comments
Leave a Reply.AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |