Computer software performance qualification

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

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

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). 

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. ... 

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. 

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). 

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. 

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. 

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 Certification Plan for Reactor Analysis Computer Codes includes a user qualification section. This section contains a user qualification and function checklist that specifies the minimum requirements for each user level and the associated access (authorization or control) level (i.e., from apprentice to proprietor) necessary to perform required code alterations. DOE review of this Certification Plan for Reactor Analysis Computer Codes indicated that it is an acceptable plan for access control. At present, master copies for many of the codes listed in the Certification Plan are archived in the Software Configuration Management System (SCMS), which is controlled by the NRTSC Scientific Computations Section (SCS). 

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