Computer software user required specification

User requirement specifications (URS) for the computerized system are provided by the pharmaceutical firm to the computer systems vendor. The vendor generates functional and design specifications as a basis for designing and coding software for the computerized system. The system is then built, together with all the interfaces to the hardware, and tested by the vendor. After installation of the computerized system, IQ, OQ, and PQ are performed at the pharmaceutical facility to verify that the system is able to meet the URS and design and functional specifications. 

A computer system is composed of software and hardware, equipment, a processor, and a user, and it is used to execute a specific procedure. Regardless of whether the computer system is developed in-house or by a contractor or purchased off the shelf, establishing documented end-user requirements is extremely important for computer systems validation. Without first establishing end-user needs and intended use, it is virtually impossible to confirm that the system can consistently meet them. Once established, it should obtain evidence that the computer system implements those needs correctly and that they are traceable to system design requirements and specifications. It is important that the end-user requirements specifications take into account predicate rules [12]. 

An Outline Specification is usually required to sanction a project and authorize the allocation of a budget. It typically presents the business case for the computer system, defining key functionality and compliance requirements. This document may be used later on for developing the User Requirements Specification (URS) as discussed in Chapter 7. Where Commercial Off-The-Shelf (COTS) software and systems are being acquired, this document may be used as the URS. Outline Specifications must be reviewed and approved. 

The performance of the complete system should be validated against the User Requirements Specifications. The system combines the instrument hardware, computer hardware and software, and the analytical method. In chromatography, it also includes a column... 

Increases in processor speeds and storage capacity allowed these system to acquire and process data rapidly. Many fourth-generation systems became nodes in laboratory computer UMS networks. They communicate with host computers to receive instructions for analyses and for transferring results. Programs and values of parameters for specific analytical methods can be stored in memory and recalled by the analyst as needed. While the analyst found interaction with these systems easier, he or she became further removed from the system components and often more dependent on the vendor s software. Tailoring requirements to individual user requirements was often not viable with this approach. 

The main business reasons to validate computer systems are to demonstrate conformance with the system requirements specification, to increase acceptance of the systems by end-users, and to avoid high maintenance costs. Regarding maintenance costs, Figure 2-2 depicts the relative cost in 1976 of repairing software. At present, the proportions are similar. The longer a defect is uncovered, the more expensive it is to repair. 

The FAT provides evidence that the hardware and software are fully integrated, that they operate as indicated in the computer system specification deliverable, and meet the expectations of the user as defined in the requirements specification deliverable. This final formal integration test should be completed in an environment very similar to the operational environment. The system can be subjected to a real-world environment by using emulators and/or simulators which mimic system interfaces. The user s representative should evaluate the supporting documents, the operation, system functionality, and system reliability. 

Abstract Software and computer systems are tested during all development phases. The user requirements and functional specifications documents are reviewed by programmers and typical anticipated users. The design specifications are reviewed by peers in one to two day sessions and the source code is inspected by peers, if necessary. Finally, the function and performance of the system is tested by typ-... 

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. 

All software and computer systems used in accredited and GLP- and GMP-regulated analytical laboratories for the generation and analysis of critical data should be retrospectively evaluated and formally validated. As a first step, the user should list all systems in the laboratory, assess the need for validation for each system and develop an implementation plan. For validation of individual systems, the validation plan should describe user requirements and specific validation steps. It should also list the person or persons responsible for each step as well as the criteria that must be met to achieve validated status. 

Overall, most of the requirements for a process spectrometer/analyzer are straightforward to implement, but they do require attention at the design level. Another important area, which is FTIR specific, is the user interface and the need to provide for industry standard data communications. Standard software packages do exist for process instrumentation. For prototype development, and even for the front-end interface in a stand-alone mode of operation, software products, such as National Instraments Lab View and the Mathworks MatLab, are also important instrumentation development tools. Note that National Instruments also provides important computer-based electronics and hardware that meet most of the computer interfacing, and system control and communications needs for modem instrumentation. For practical installations, a product known... 

This article should help to get around the dilemma and to establish an efficient vendor qualification program for different software categories with minimum efforts. The computer systems will be classified as standard systems and software or systems that have been developed on a contract basis specifically for the user. Special attention is paid to the requirements of users in regulated pharmaceutical industries. 

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