Computer software installation qualification

Installation qualification is documented verification that the computer system (including all required software) is installed satisfactorily and is compliant with appropriate engineering codes, manufacturer recommendations, and approved specifications, and that the instrumentation is calibrated and all services are available and of adequate quality. 

Due to the close relationship between the computer hardware and the system software, operating system installation verification may be performed during the hardware installation qualification activities. 

Installation Qualification (IQ) provides documented verification that instrumentation, computer hardware, operating system software, and application software have been purchased, received, and installed according to requirements and design. 

Assurance that equipment (including computer systems and software), which has been qualified (installation, operational, and performance qualification), is maintained in a qualified state. 

Correct functioning of software and computer systems should be verified after installation and before routine use. Operational qualification for software and computer systems is more difficult than for hardware, as 1) it is more difficult to define specifications, test procedures, and acceptance criteria and 2) there are hardly any guidelines available on OQ of software and computer systems. Because of these problems, there is even more uncertainty for software and computer systems than for equipment hardware. 

Proper functioning and performance of equipment play a major role in obtaining consistency, reliability and accuracy of analytical data. Therefore equipment should be properly selected, designed, installed, and operated, and the correct function and performance should be verified before and during operation. This holds for equipment hardware, computer hardware, hardware interfaces, and software and computer systems. Qualification of equipment hardware is well established and has been described by several authors [1-4], and typically users in analytical laboratories are quite familiar with testing equipment for hardware specifications. 

Abstract Installation and operational qualification are important steps in the overall validation and qualification process for software and computer systems. This article guides users of such systems step by step through the installation and operational qualification procedures. It provides guidelines on what should be tested and documented during installation prior to... 

Qualification and validation of software and computer systems in laboratories. Part 3 Installation and operational qualification 47... 

After the installation of hardware and software, an operational test should follow, a process which is referred to as operational qualification (OQ). For the qualification of computer systems, the term acceptance is also used, which can be identical to or be a reduced set of the OQ. The purpose of OQ is to demonstrate that the system s hardware and software operate as intended in the user s environment. 

Software and computer systems used in analytical laboratories that must comply with good laboratory practice (GLP) and good manufacturing practice (GMP) regulations require formal validation to confirm that they meet the criteria for intended use. Both new and existing systems, regardless of age, must be validated for their suitability for indented use. Whereas the first three articles in this series [1-3] focused on validation during development, vendor qualification, and installation and operational qualification of new systems, this article describes the procedures for systems that have been purchased, installed, and used prior to formal validation and that must be newly documented. 

As emphasized previously (Bansal 2004), software for instrument control, data acquisition and processing is nowadays usually all loaded on a computer connected to the instrument. Thus the functions of both hardware and software in providing analytical data are inextricably intertwined and the DQ should be performed by the manufacturer, who should also validate this software and provide users with a summary of the validation. However, in the installation phase, qualification of the entire instrument and software system is more efficient and indeed meaningful than modular vahdation of the software and hardware separately. Thus, the user qualifies the instrument control, data acquisition and processing software by testing the instrument according to the AIQ process described in Section 9.5.1a. 

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