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Computerized Systems Validation
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
While the Quality System regulation states that design input requirements must be documented and that specified requirements must be verified, the regulation does not further clarify the distinction between the terms “requirement” and “specification.” A requirement can be any need or expectation for a system or for its software. Requirements reflect the stated or implied needs of the customer and may be market-based, contractual, or statutory, as well as an organization’s internal requirements. There can be many different kinds of requirements (e.g., design, functional, implementation, interface, performance, or physical requirements). Software requirements are typically derived from the system requirements for those aspects of system functionality that have been allocated to software. Software requirements are typically stated in functional terms and are defined, refined, and updated as a development project progresses. Success in accurately and completely documenting software requirements is a crucial factor in successful validation of the resulting software.
Product Development
Published in Paul H. King, Richard C. Fries, Arthur T. Johnson, Design of Biomedical Devices and Systems, 2018
Paul H. King, Richard C. Fries, Arthur T. Johnson
The system requirements specification includes the following types of requirements: Functional requirements: these requirements specify what the device does, focusing on the operational capabilities of the device and processing of inputs and the resultant outputs.Physical and performance requirements: these requirements specify how much or how well the design must perform, addressing such issues as speed, strength, size, weight, response times, accuracy, precision, limits of operation, device safety, and reliability.Interface requirements: these requirements specify characteristics that are critical to compatibility with external systems (including user and/or patient interface).System architecture: these requirements specify relationships among logical functions, physical systems/subsystems, and interfaces.Software requirements (if applicable): these requirements specify product functionality to be implemented through software and the functional, performance, interface, and safety requirements for the software subsystem(s).
ISO Standards
Published in Boris Mutafelija, Harvey Stromberg, ® v1.2 and ISO Standards, 2008
Boris Mutafelija, Harvey Stromberg
In the Software Requirements Analysis process, the system requirements allocated to each software item are analyzed to develop the software requirements. Software requirements must be traceable to, and consistent with, the system requirements and system architecture. Software requirements include specification of functional requirements; performance requirements; interfaces; safety and security requirements; qualification and acceptance requirements; and user documentation, operations, and maintenance requirements.
Using intelligent ontology technology to extract knowledge from successful project in IoT enterprise systems
Published in Enterprise Information Systems, 2022
Jinfeng Ding, TianRan Tang, Yaqin Zhang, Wi Chi
What knowledge exists in software development process. Software requirements engineering is a process of discovery, refinement, modelling, and specification. Models of the required data, informtion and control flow, business process, and operational behaviour are created. We are pushed to design some classes to support the same type of application, transaction processing type system, from banking software. One of important reasons and benefit is reuse. Team B uses a robust class library and fins. In other words, the ideas to design a common class library that is from the knowledge base of user requirement and business domain (Chen et al. 2021, 2020).
Selection of software requirements using TOPSIS under fuzzy environment
Published in International Journal of Computers and Applications, 2022
Mohd. Sadiq, Shadab Khan, Chaudhary Wali Mohammad
Software requirements (SRs) are the need of the stakeholders which are divided into ‘functional requirements’ (FRs) and ‘non-functional requirements’ (NFRs). These requirements are identified from the goal of the stakeholders after applying the group of requirements elicitation techniques [3–5,37]. It has been observed that the lack of the SRs is one of the reasons for the software failure [2]. So, it is essential to identify the FR and NFRs before the implementation of software [3]. In our method, we apply the traditional techniques [38,39] and ‘goal oriented requirements elicitation technique’ (GORET) [40] for the identification of the SRs.