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Computerized System Validation
Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records. This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules. System requirement Documented system requirements are required for CSV as they clearly stipulate the intended use of a computer system application. System requirements are gathered and documented in the system definition phase. System definition artifacts that reflect these requirements can include, but are not ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
System Requirements
To be used efficiently, all computer software needs certain hardware components or other software resources to be present on a computer. These prerequisites are known as (computer) system requirements and are often used as a guideline as opposed to an absolute rule. Most software defines two sets of system requirements: minimum and recommended. With increasing demand for higher processing power and resources in newer versions of software, system requirements tend to increase over time. Industry analysts suggest that this trend plays a bigger part in driving upgrades to existing computer systems than technological advancements. A second meaning of the term of system requirements, is a generalisation of this first definition, giving the requirements to be met in the design of a system or sub-system. Recommended system requirements Often manufacturers of games will provide the consumer with a set of requirements that are different from those that are needed to run a software. The ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
User Requirements Specification
The user requirement(s) document (URD) or user requirement(s) specification (URS) is a document usually used in software engineering that specifies what the user expects the software to be able to do. Once the required information is completely gathered it is documented in a URD, which is meant to spell out exactly what the software must do and becomes part of the contractual agreement. A customer cannot demand features not in the URD, while the developer cannot claim the product is ready if it does not meet an item of the URD. The URD can be used as a guide for planning cost, timetables, milestones, testing, etc. The explicit nature of the URD allows customers to show it to various stakeholders to make sure all necessary features are described. Formulating a URD requires negotiation to determine what is technically and economically feasible. Preparing a URD is one of those skills that lies between a science and an art, requiring both software technical skills and interperson ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Software Testing
Software testing is the act of examining the artifacts and the behavior of the software under test by validation and verification. Software testing can also provide an objective, independent view of the software to allow the business to appreciate and understand the risks of software implementation. Test techniques include, but not necessarily limited to: * analyzing the product requirements for completeness and correctness in various contexts like industry perspective, business perspective, feasibility and viability of implementation, usability, performance, security, infrastructure considerations, etc. * reviewing the product architecture and the overall design of the product * working with product developers on improvement in coding techniques, design patterns, tests that can be written as part of code based on various techniques like boundary conditions, etc. * executing a program or application with the intent of examining behavior * reviewing the deployment infrastructure a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Software Engineering
Software engineering is a systematic engineering approach to software development. A software engineer is a person who applies the principles of software engineering to design, develop, maintain, test, and evaluate computer software. The term '' programmer'' is sometimes used as a synonym, but may also lack connotations of engineering education or skills. Engineering techniques are used to inform the software development process which involves the definition, implementation, assessment, measurement, management, change, and improvement of the software life cycle process itself. It heavily uses software configuration management which is about systematically controlling changes to the configuration, and maintaining the integrity and traceability of the configuration and code throughout the system life cycle. Modern processes use software versioning. History Beginning in the 1960s, software engineering was seen as its own type of engineering. Additionally, the development of s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
List Of Software Engineering Topics
The following outline is provided as an overview of and topical guide to software engineering: Software engineering – application of a systematic, disciplined, quantifiable approach to the development, operation, and maintenance of software; that is the application of engineering to software. The ACM Computing Classification system is a poly-hierarchical ontology that organizes the topics of the field and can be used in semantic web applications and as a defacto standard classification system for the field. The major section "Software and its Engineering" provides an outline and ontology for software engineering. Software applications Software engineers build software (applications, operating systems, system software) that people use. Applications influence software engineering by pressuring developers to solve problems in new ways. For example, consumer software emphasizes low cost, medical software emphasizes high quality, and Internet commerce software emphasizes ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Assurance
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to ensure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a ''shift left'' since it focuses on quality eff ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Control
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): # Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records # Competence, such as knowledge, skills, experience, and qualifications # Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. History and introductio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
