Computer software operation qualification

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 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. 

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 ... 

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. 

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. 

During operational qualification, the software and computer system is verified against the functional specifications. For integrated analytical computerized systems the tests mainly consist of running well-characterized test samples, and the communication to the equipment hardware should be checked as well. For testing the computer system only, laboratory-specific data sets and evaluation procedures can be used. 

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. 

For equipment or systems controlled or monitored by a computer-related system, the functional testing cycle approach to computer validation is included and performed as part of the Operational Qualification. Functional testing verifies that the integrated hardware and software program perform in accordance with the functional specifications developed during the requirements phase. 

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... 

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 ... 

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). 

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. 

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

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-... 

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 Existing software and computer systems in laboratories require retrospective evaluation and validation if their initial validation was not formally documented. The key steps in this process are similar to those for the validation of new software and systems user requirements and system specification, formal qualification, and procedures to ensure ongoing performance during routine operation. 

The assessment and qualification of software for computer based systems important to safety requires (as e g. in lEC 60880) a set of detailed documents according to the development steps of the software life cycle. For pre-developed software the amount of documentation available and its detail will not be sufficient in most cases. On the other hand, the pre-developed software may have been operating in many applications, and it should be possible to evaluate this operating experience to demonstrate dependability. 

All regulatory agencies adopt what amounts to a life cycle approach to developmental and operational control of computerized equipment, with emphasis on documentation of software development and quahty management especially in GLP environments. The life cycle for analytical instruments from the user s perspective includes the purchasing phase (including system/vendor qualification), the IQ, OQ and PQ phases of AIQ (Section 9.5.1a), the maintenance phase and, fmaEy, the retirement phase, which probably occurs more frequently with respect to computers and software than the analytical instruments... 

The qualification exercise included parts of computer and software validation as well as equipment qualification. To ensure a coherent qualification it was determined that portions of the computer and software validation would be subject to an interim approval. This would allow specified computerized systems validation tasks to be completed prior to making equipment operational, and subsequently performance qualification (6,7). 

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. 

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