ולידציה - Installation Qualification (IQ) Protocol - 2
Installation Qualification (IQ) Protocol - Test Procedures. This article describes the test procedures for the installation of purchased software (SW) and ap…
פורסם:
Installation Qualification (IQ) Protocol Preparation Overview - part 2 Installation Qualification (IQ) Protocol - Test Procedures This chapter contains all the test procedures or verifications required to verify the system under validation is properly installed and can be properly operated according to the supplier's requirements and user's specifications . Each test procedure or verification must include the same contents: Purpose or Objective Procedure or Method Acceptance Criteria Test Results The next sections provide overviews of the main test procedures and verifications, and their purposes. This IQ procedure is generic, and relevance of the test procedures and verifications provided below depends on the composition of the system under validation . Note: As mentioned in the previous chapter on IQ Protocol Contents, the final contents of the IQ protocol are tailored according to the type and size of the system under validation . Since this document is generic, it covers test procedures that may not be necessary in small or simple systems. Drawings Verification This procedure is intended to obtain signed, updated copy of the user's Piping and Instrumentation Drawing (P&ID), and verify that the drawing is accurate. Site Preparations This procedure is intended to verify that the system under validation is installed and operated under environmental conditions, in particular temperature conditions, which comply with the manufacturer’s requirements. Hardware Installation Test Procedures Voltage Supply This procedure is intended to verify that the voltage supplied to the system components complies with the design requirements. IO List This procedure is intended to verify that the system components are identified and installed in compliance with the IO List, the P&ID, and the system hardware requirements. Software Installation Test Procedures This section describes the test procedures for the installation of purchased software ( SW ) and application SW. These test procedures are relevant when the supplier installs these SW systems. Supplier Installed Software This procedure is intended to verify that purchased SW installed in the supervisory computer and control system (where relevant) by the supplier complies with the SW design requirements. Other Purchased Software This procedure is intended to verify that other purchased SW, such as a version of Windows, is correctly installed on the system. Application Software This procedure is intended to verify that the custom application SW is installed according to the design requirements. Closed System Verification (Where Relevant) This procedure is intended to verify that the system is closed, i.e., it cannot communicate with Internet networks. Glossary CFR Code of Federal Regulations FDA Food and Drug Administration FRS Functional Requirements Specification HW Hardware IQ Installation Qualification OQ Operational Qualification QA Quality Assurance SSO Schedule of System Operation SW Software URS User Requirements Specification