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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 are not necessarily limited to:
Medical software is any software item or system used within a medical context, such as:reducing the paperwork, tracking patient activity
In product development and process optimization, a requirement is a singular documented physical or functional need that a particular design, product or process aims to satisfy. It is commonly used in a formal sense in engineering design, including for example in systems engineering, software engineering, or enterprise engineering. It is a broad concept that could speak to any necessary function, attribute, capability, characteristic, or quality of a system for it to have value and utility to a customer, organization, internal user, or other stakeholder. Requirements can come with different levels of specificity; for example, a requirement specification or requirement "spec" refers to an explicit, highly objective/clear requirement to be satisfied by a material, design, product, or service.
Structured Systems Analysis and Design Method (SSADM) is a systems approach to the analysis and design of information systems. SSADM was produced for the Central Computer and Telecommunications Agency, a UK government office concerned with the use of technology in government, from 1980 onwards.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
In software project management, software testing, and software engineering, verification and validation (V&V) is the process of checking that a software system meets specifications and requirements so that it fulfills its intended purpose. It may also be referred to as software quality control. It is normally the responsibility of software testers as part of the software development lifecycle. In simple terms, software verification is: "Assuming we should build X, does our software achieve its goals without any bugs or gaps?" On the other hand, software validation is: "Was X what we should have built? Does X meet the high-level requirements?"
The Federal Information Processing Standard Publication 140-2,, is a U.S. government computer security standard used to approve cryptographic modules. The title is Security Requirements for Cryptographic Modules. Initial publication was on May 25, 2001, and was last updated December 3, 2002.
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
The V-model is a graphical representation of a systems development lifecycle. It is used to produce rigorous development lifecycle models and project management models. The V-model falls into three broad categories, the German V-Modell, a general testing model and the US government standard.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
The 140 series of Federal Information Processing Standards (FIPS) are U.S. government computer security standards that specify requirements for cryptography modules.
A test plan is a document detailing the objectives, resources, and processes for a specific test for a software or hardware product. The plan typically contains a detailed understanding of the eventual workflow.
Reliability engineering is a sub-discipline of systems engineering that emphasizes the ability of equipment to function without failure. Reliability describes the ability of a system or component to function under stated conditions for a specified period of time. Reliability is closely related to availability, which is typically described as the ability of a component or system to function at a specified moment or interval of time.
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard.
Good documentation practice is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various competent authorities, others are not but are considered cGMP. Some competent authorities release or adopt guidelines, and they may include non-codified GDP / GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
ISO 26262, titled "Road vehicles – Functional safety", is an international standard for functional safety of electrical and/or electronic systems that are installed in serial production road vehicles, defined by the International Organization for Standardization (ISO) in 2011, and revised in 2018.
Specification by example (SBE) is a collaborative approach to defining requirements and business-oriented functional tests for software products based on capturing and illustrating requirements using realistic examples instead of abstract statements. It is applied in the context of agile software development methods, in particular behavior-driven development. This approach is particularly successful for managing requirements and functional tests on large-scale projects of significant domain and organisational complexity.
References
- ↑ Commissioner, Office of the (2020-06-11). "Part 11, Electronic Records; Electronic Signatures - Scope and Application". U.S. Food and Drug Administration. Retrieved 2021-09-10.
- ↑ EUROPEAN COMMISSION (2011-06-30). "EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 11: Computerised Systems" (PDF). European Commission. Retrieved 2023-03-11.