Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

User tests, computer system

Overall control is provided by the PDP-11/44, running DEC S RSX-llM operating system. RSX-llM is a multi-user multi-task operating system, and a number of other analytical instruments are interfaced to this computer system and are running concurrently. The automated Instron software is menu-driven because our experience has shown that menu-driven software is particularly effective for applications of this type. To perform either test the user accesses a main menu from which separate menus for instrument calibration, tensile tests, and flexure tests can be reached. The tensile and flexure menus have equivalent options the choices pertaining to automated testing are as follows ... [Pg.49]

For computer systems that do not require formal validation, at a minimum, user acceptance testing should be performed. This User Acceptance Testing should be outlined in a facility SOP, where the system is tested and assured to perform in the desired function effectively. The User Acceptance should be documented, and the system should be released for specific uses. [Pg.1055]

Testing must be conducted in a typical end-user environment, or in a simulated end-user environment, identical with the environment where the software/computer system will be used. Documentation of testing can be recorded as raw data, such as in a logbook, and should include the parameters tested, and the results of testing. The data should be tabulated as a final report document that includes all details included in the test plan, their execution, the results, and conclusions. The final report document must be signed by appropriate personnel, reviewed as needed, and archived. Upon successful completion of testing, the software/computer system can be released for testing and use in an actual end-user environment. [Pg.1057]

Software producers must fulfill the requirements for development, testing, and documentation. When the user is confident that these requirements have been met, and the system functions adequately to fulfill his or her needs, the user must perform validation prior to placing the software in service. An analytical laboratory is an example of an end-user that conducts testing prior to software/computer system installation. [Pg.1058]

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. [Pg.304]

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. [Pg.71]

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. [Pg.57]

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. [Pg.224]

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. [Pg.110]

The Design Review provides a feedback mechanism into the Design and Development phase to refine the design of the computer system before construction begins in the System Build phase. The Design Review can also be nsed to carry forward issues to be tested during Development Testing and User Qualification. [Pg.110]

PQ has often been the least understood phase of User Qualification. This is probably because the character of PQ testing can vary considerably between different computer systems. [Pg.114]

User Procedures for operating and maintaining the computer systems must be specified, approved, and, where possible, tested before the systems are approved for use. Projects should aim to use and thereby test User Procedures within User Qualification activities. This approach offers the opportunity to use end-users to help conduct testing with the User Procedures. This can often be coordinated as a training exercise. User Procedures can be refined by end-users themselves in readiness for handover of the computer system. [Pg.115]

Any assembly problems should be resolved before the system is released for Development Testing. If necessary, assembly procedures should be revised with any necessary corrections. Packaged computer systems do not need to be disassembled during Development Testing or User Qualification so long as assembled hardware units are sealed. [Pg.225]

Evidence of effective Development Testing can reduce the amount of subsequent User Quali-hcation expected by GxP regulatory authorities. The pharmaceutical or healthcare company will often endeavor to include in its User Qualification as many tests as possible from Development Testing. It should also reduce the time needed to commission the computer system on the pharmaceutical or healthcare company s site, as qualification can focus on confirming an already established operational capability. [Pg.234]

Functional Testing is testing the system from a user s perspective — i.e., without knowledge of the internal architecture and structure of the system. Inventory checks are made by visual inspection, while functionality is verified by running the computer system. Test scenarios should include ... [Pg.243]

Operational Qualification (OQ) provides documented verification that a computer system operates according to written and preapproved specifications throughout all its specified operating ranges. OQ should only commence after the successful completion of the IQ. In short it comprises user acceptance testing, for it is necessary to demonstrate that the computer system operates in... [Pg.264]

Operations personnel must be able to use all operating procedures before the computer system is cleared for live use. User Standard Operating Procedures (SOPs) can be used to confirm system fimctionality. Any competencies required to conduct these tests, including training on user SOPs, should be given and recorded before testing begins. [Pg.266]

For a computer system in an analytical laboratory, OQ can mean, for example, verifying correct communication between the computer and other hardware. As part of the product documentation, vendors should provide operating procedures for the tests, limits for acceptance criteria, and recommendations in case these criteria cannot be met. The documentation should also include algorithms for critical calculations and procedures on how to verify the algorithms in a user s environment. If the user finds the tests recommended by the vendor inappropriate or insufficient, the user can design and perform other or additional tests. [Pg.458]

The correct functioning of software loaded on a computer system should be checked in the user s laboratory under typical operating conditions and under high load conditions. During the equipment hardware test, as described in the previous section, many software functions are also executed, such as instrument control, data acquisition, peak integration, quantitation, file storage and retrieval, and printing. Therefore, after successful completion of hardware tests, it can also be assumed that the software operates as intended. There are two situations where software verification independent of the equipment hardware may be necessary ... [Pg.459]

Preferably, tests and the documentation of results should be done automatically, always using the same set of test files. In this way, users are encouraged to perform the tests more frequently, and user specific errors are eliminated. In some cases, vendors provide test files and automated test routines for verification of a computer system s performance in the user s laboratory. Needless to say, the correct functioning of this software should also be verified. If such software is not available, the execution of the tests and the verification of actual results with prerecorded results can be done manually. Successful execution of such a procedure ensures that ... [Pg.460]

If computer systems are upgraded with new operating systems or when new hardware is added, the user should thoroughly document the upgrade and perform acceptance testing as for a new system. The use of existing test hies and automated procedures can make this process very efficient. [Pg.463]

A validation protocol is a documented, pre-agreed sequence of activities that are to be executed by a nominated team of people who are to review and test the computer system or part thereof. The objective of the protocol is to provide documented evidence that the system is installed correctly and will operate reliably and consistently to meet all user and regulatory requirements. [Pg.927]

These tests, along with all other validation activities, may be summarized in an overall computer system Validation Plan (VP) which is prepared early in the system development life cycle (often concurrent with the system-detailed user requirements definition). [Pg.928]

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). [Pg.1696]

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-... [Pg.24]

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. [Pg.24]

Even though the definitions look similar, there is a distinct difference. While verification is of general nature, validation refers to specific intended use . In this sense a computer system that is developed for multiple users with multiple applications is verified rather that validated at the vendor s site. When the system is installed at the user s site for a specific task and the system is tested to meet the previously specified requirements, this process is defined as validation. If the system is intended to be used for different applications and more generic tests are done in the sense of EN ISO 8402 1995, this process again is called verification. [Pg.25]

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... [Pg.46]

When the computer system arrives, the shipment should be checked by the user for completeness. It should be confirmed that the equipment ordered is what was in fact received. Besides the equipment hardware, other items should be checked, for example correct cables, other accessories and documentation. A visual inspection of the entire hardware should follow to detect any physical damage. For more complex instrumentation, for example, when multiple computers are connected to a network, wiring diagrams should be produced, if not supplied by the vendor. Distance between the computers and peripherals such as printers and analytical equipment must be within manufacturer s specifications. For example, long low-voltage electrical lines from analytical equipment to computers are vulnerable to electromagnetic interference. This may result in inaccurate input data to the computer. In addition, electrical lines should be shielded if motors or fluorescent light sources are nearby. At the end of the installation of the hardware an electrical test of all computer modules and systems should follow. [Pg.47]


See other pages where User tests, computer system is mentioned: [Pg.1043]    [Pg.120]    [Pg.110]    [Pg.250]    [Pg.230]    [Pg.36]    [Pg.233]    [Pg.595]    [Pg.102]    [Pg.203]    [Pg.233]    [Pg.250]    [Pg.304]    [Pg.422]    [Pg.555]    [Pg.762]    [Pg.2296]    [Pg.1693]    [Pg.46]    [Pg.46]   


SEARCH



Computer systems

System testing

Test systems

User systems

User test

© 2024 chempedia.info