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 |