It verifies the proper installation and configuration of a system. This may include ensuring that the necessary files have been uploaded, equipment has been installed, power supplies (whether air, power, software, internet, etc.) have been installed, necessary procedures have been approved, or appropriate personnel have been trained. The requirements to properly install the system were defined in the design specification. Installation qualification must be performed prior to completing the operational qualification or performance qualification.
Published in Chapter:
Validation of the Sealing Machine Process for Surgical Packs: A Methodological Approach
Karina Cecilia Arredondo-Soto (Universidad Autónoma de Baja California, Mexico), Maria Marcela Solís-Quinteros (Universidad Autónoma de Baja California, Mexico), Marco Augusto Miranda-Ackerman (Universidad Autónoma de Baja California, Mexico), and Julio Blanco-Fernàndez (Universidad de la Rioja, Spain)
Copyright: © 2022
|Pages: 31
DOI: 10.4018/978-1-7998-9613-5.ch010
Abstract
A manufacturing plant in Tijuana focused on providing medical device solutions to improve the quality of life of patients. The company has developed thanks to its innovative products in the market considerably. As a business strategy at the corporate level, opportunities were detected and involved the transfer of the manufacturing of products to different facilities in Mexico. In order to manufacture a product that complies with standards to ensure the sterile barrier standards to ensure sterilization barrier of the product, this project consists of validating the Max Tray Sealer machine of the kit kat two production lines. The validations process covers all the quality system requirements governed under the ISO-13485 standards, which define the validation stages. The stages of the validation include the installation qualification, the operational qualification, and the performance qualification.