Computer software qualification

Chapter 10 covers the subject of computer systems qualification, including sample qualification using the GAMP software categories. 

Key words Validation Qualification Computers Software Analytical Laboratories... 

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. 

Today most instruments are computer driven. The computer can control any or all of the following instrument operation, data acquisition, data storage/processing, and report generation. As a consequence, software validation is another important aspect of instrument qualification. However, software qualification is currently a much-debated area and is beyond the scope of this presentation. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

The computer system attached to the instrument provides instrument control, data acquisition, data processing, and reporting. According to the draft Analytical Instrument Qualification chapter of the United States Pharmacopoeia (USP) <1058> The manufacturer should perform design qualification, validate the software and provide users with a summary of the validation. At the user site, holistic qualification that involves the entire instrument and software system is more efficient than modular validation of the software alone. Therefore the user qualifies the instrument control, data acquisition and processing software by qualifying the instrument. ... 

It is also important that the extent of the FAT is maximized. This will reduce the risk of problems arising during the final acceptance tests carried out on site and during system qualification. At this stage any dynamic testing considered for real-time computer process control systems will need to be undertaken utilizing simulation software, which in itself may need to be validated. 

The computer system URS and FDS, the subsequent software and hardware design specifications, and instrument data sheets are the reference documents for qualification protocol development. The basis and acceptance criteria for each test should be derived from the system parameters, data, and function requirements that have been specified. It is advantageous to commence development of the test procedures at the same time as the respective specifications— this to best ensure that requirements and tests correspond, are traceable, and can be better understood. 

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. 

Operational Testing. The computer system should be operationally tested by the operators/users. Operational testing is the exercise of the verified applications software in the certified hardware/operations software system using test or simulated data. This can be accomplished in conjunction with the documentation of the operational qualification of the hardware/operating software and/or during the validation testing. 

Black box testing is also known as functional testing, benchmark testing and, in the pharmaceutical community, as an operational qualification (OQ). It tests the functionality and correctness of a computer system by running the integrated software, and is performed for one of two reasons defect detection, and/or reliability estimation. It should cover all functions of the application software that the end-user will use, and will verily the completeness and accuracy of system requirements used to define the test cases. 

The qualification of computer hardware, software and the verification of associated documentation are performed according to the applicable sections in Chapter 7. 

This chapter describes the general practices for the qualification of computer systems (system software, application software and hardware) that perform regulated operations. The following areas are discussed ... 

The system operational qualification performed on the computing technology provides documented evidence of a high degree of assurance that the hardware and software components perform as required by the system specification. This includes the verification that each unit or subsystem of the system operates as intended throughout all anticipated operating ranges. Appropriate personnel must conduct the system operational qualification. 

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. 

The purpose of performing a hardware/software supplier qualification is to assess the computing environments and technology products used to develop regulated applications. 

Computer Systems Validation (CSV) The formal assessment and reporting of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance, and retirement, such that the user has a high level of confidence in the integrity of both the processes executed within the controlling computer system(s), and in those processes controlled by and/or linked to the computer system(s), within the prescribed operating environments) (MCA). 

Qualification protocols are written documents prepared before conducting the qualification, describing the features of a particular application or item and how it should be tested. Qualification protocols identify the objectives, methods, and acceptance criteria for each test function contained in the applicable specification deliverable and identifies who is responsible for conducting the tests. In addition, the protocols should also specify how the data is to be collected, reported, and analyzed to determine if the acceptance criteria were met. The protocol should be reviewed by personnel with an appropriate understanding of computer systems and the functionality of the indicated system. Following the review, qualified personnel must approve each protocol in accordance with the company quality assurance procedures. In the software engineering world, qualification protocols are equivalent to test procedures. Traditionally the scope of the qualification protocols encompasses the following ... 

Operating Mannals need to be formally reviewed as fit for purpose by the supplier as they form the basis of User Procedures and User Qualification. Operating Manuals must be kept up to date with developments to the compnter systems to which they relate, and they mnst refer to specific hardware models and software versions making up the computer system being snpplied. Recommended ways of working defined by the snpplier should be verified as part of the development testing. 

Qualification of the infrastructure (computers, system software, and network)... 

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. 

Following IQ, Operational Qualification (OQ) provides documented verification that the process equipment, instrumentation, computer hardware, and software operate as expected. OQ testing may include the following verifications ... 

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

Validation of HPLC instrumentation, also called qualification, is the procedure that ensures that the instrument is qualified that is, that its performance complies with the method s predetermined requirements, providing reliable and valid results. Modern HPLC systems are computerized, generally consisting of analytical hardware, computer hardware, peripherals, and software. 

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. 

The type of testing required for the qualification of software and computer systems depends very much on the type and complexity of software, i.e., if the software and computer hardware are supphed by one vendor, or computer systems that are interconnected and/or interfaced to analytical systems, or if the software are developed in the user s laboratory in addition to a vendor-supplied package (e.g., a macro). 

The validation of analytical methods is a well-known problem in the analytical community [1], The international guidance for equipment qualification (EQ) of analytical instruments and their validation is in the development stage [2-4], At this time validation of computer systems for analytical instruments is less elaborated [5-7], The term computer system comprises computer hardware, peripherals, and software that includes application programs and operating environments (MS-DOS, MS-Windows and others) [5, 6], Since programs, software and the whole computer system are elements of the instrument used by the analyst according to the analytical method, successful validation of the method as a black box [8] means successful validation of the instrument, computer system, software and programs. On the other hand, the same instrument may also be calibrated and validated as a smaller (in-... 

Qualification and validation of software and computer systems in laboratories... 

This first article describes the validation and qualification of computer systems such as those for instrument control and data evaluation during development. Development validation of computer systems purchased from a vendor typically is done at the vendor s site, and even though most computer systems and software in analytical laboratories are purchased from vendors it was felt that such an article makes sense for users of such systems for two reasons ... 

Because there is still a misunderstanding of terms such as validation, qualification and verification, these will be explained right at the beginning. It is also important to understand the terms computer system and computerized systems and the different types of software loaded on a computer, but other publications should be consulted for this type of information. 

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