Software Of Unknown Pedigree
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Software Of Unknown Pedigree
SOUP stands for software of unknown (or uncertain) pedigree (or provenance), and is a term often used in the context of safety-critical and safety-involved systems such as medical software. SOUP is software that has not been developed with a known software development process or methodology, or which has unknown or no safety-related properties. Often, engineering projects are faced with economic or other pressure to embody SOUP into their high integrity systems. The problem with SOUP is that it cannot be relied upon to perform safety-related functions, and it may prevent other software, hardware or firmware from performing their safety-related functions. The SOUP problem is therefore one of insulating the safety-involved parts of a system from the SOUP and its undesirable effects. SOUP is now a defined term ("Software Of Unknown Provenance") in some medical device regulations through the standard IEC 62304:2006 "medical device software – software life cycle processes". It is ...
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Software
Software is a set of computer programs and associated documentation and data. This is in contrast to hardware, from which the system is built and which actually performs the work. At the lowest programming level, executable code consists of machine language instructions supported by an individual processor—typically a central processing unit (CPU) or a graphics processing unit (GPU). Machine language consists of groups of binary values signifying processor instructions that change the state of the computer from its preceding state. For example, an instruction may change the value stored in a particular storage location in the computer—an effect that is not directly observable to the user. An instruction may also invoke one of many input or output operations, for example displaying some text on a computer screen; causing state changes which should be visible to the user. The processor executes the instructions in the order they are provided, unless it is instructed ...
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Safety-critical
A safety-critical system (SCS) or life-critical system is a system whose failure or malfunction may result in one (or more) of the following outcomes: * death or serious injury to people * loss or severe damage to equipment/property * environmental harm A safety-related system (or sometimes safety-involved system) comprises everything (hardware, software, and human aspects) needed to perform one or more safety functions, in which failure would cause a significant increase in the safety risk for the people or environment involved. Safety-related systems are those that do not have full responsibility for controlling hazards such as loss of life, severe injury or severe environmental degradation, environmental damage. The malfunction of a safety-involved system would only be that hazardous in conjunction with the failure of other systems or human error. Some safety organizations provide guidance on safety-related systems, for example the Health and Safety Executive (HSE) in the Un ...
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Safety-involved
A safety-critical system (SCS) or life-critical system is a system whose failure or malfunction may result in one (or more) of the following outcomes: * death or serious injury to people * loss or severe damage to equipment/property * environmental harm A safety-related system (or sometimes safety-involved system) comprises everything (hardware, software, and human aspects) needed to perform one or more safety functions, in which failure would cause a significant increase in the safety risk for the people or environment involved. Safety-related systems are those that do not have full responsibility for controlling hazards such as loss of life, severe injury or severe environmental damage. The malfunction of a safety-involved system would only be that hazardous in conjunction with the failure of other systems or human error. Some safety organizations provide guidance on safety-related systems, for example the Health and Safety Executive (HSE) in the United Kingdom. Risks of thi ...
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Medical Software
Medical software is any software item or system used within a medical context, such as:reducing the paperwork, tracking patient activity * standalone software used for diagnostic or therapeutic purposes; * software embedded in a medical device (often referred to as "medical device software"); * software that drives a medical device or determines how it is used; * software that acts as an accessory to a medical device; * software used in the design, production, and testing of a medical device; or * software that provides quality control management of a medical device. History Medical software has been in use since at least since the 1960s, a time when the first computerized information-handling system in the hospital sphere was being considered by Lockheed. As computing became more widespread and useful in the late 1970s and into the 1980s, the concept of "medical software" as a data and operations management tool in the medical industry — including in the physician's office — ...
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Software Development Process
In software engineering, a software development process is a process of dividing software development work into smaller, parallel, or sequential steps or sub-processes to improve design, product management. It is also known as a software development life cycle (SDLC). The methodology may include the pre-definition of specific deliverables and artifacts that are created and completed by a project team to develop or maintain an application. Most modern development processes can be vaguely described as agile. Other methodologies include waterfall, prototyping, iterative and incremental development, spiral development, rapid application development, and extreme programming. A life-cycle "model" is sometimes considered a more general term for a category of methodologies and a software development "process" a more specific term to refer to a specific process chosen by a specific organization. For example, there are many specific software development processes that fit the spiral ...
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Software Development Methodology
In software engineering, a software development process is a process of dividing software development work into smaller, parallel, or sequential steps or sub-processes to improve design, product management. It is also known as a software development life cycle (SDLC). The methodology may include the pre-definition of specific deliverables and artifacts that are created and completed by a project team to develop or maintain an application. Most modern development processes can be vaguely described as agile. Other methodologies include waterfall, prototyping, iterative and incremental development, spiral development, rapid application development, and extreme programming. A life-cycle "model" is sometimes considered a more general term for a category of methodologies and a software development "process" a more specific term to refer to a specific process chosen by a specific organization. For example, there are many specific software development processes that fit the spiral ...
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High Integrity Software
High-integrity software is software whose failure may cause serious damage with possible "life-threatening consequences." “Integrity is important as it demonstrates the safety, security, and maintainability of… code.” Examples of high-integrity software are nuclear reactor control, avionics software, and process control software. A number of standards are applicable to high-integrity software, including: * DO-178C, Software Considerations in Airborne Systems and Equipment Certification * CENELEC EN 50128, Railway applications - Communication, signalling and processing systems - Software for railway control and protection systems * IEC 61508, Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems (E/E/PE, or E/E/PES) See also * Safety-critical system * High availability software * Formal methods * Software of unknown pedigree SOUP stands for software of unknown (or uncertain) pedigree (or provenance), and is a term often used in the context ...
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2006 "medical Device Software – Software Life Cycle Processes"
6 (six) is the natural number following 5 and preceding 7. It is a composite number and the smallest perfect number. In mathematics Six is the smallest positive integer which is neither a square number nor a prime number; it is the second smallest composite number, behind 4; its proper divisors are , and . Since 6 equals the sum of its proper divisors, it is a perfect number; 6 is the smallest of the perfect numbers. It is also the smallest Granville number, or \mathcal-perfect number. As a perfect number: *6 is related to the Mersenne prime 3, since . (The next perfect number is 28.) *6 is the only even perfect number that is not the sum of successive odd cubes. *6 is the root of the 6-aliquot tree, and is itself the aliquot sum of only one other number; the square number, . Six is the only number that is both the sum and the product of three consecutive positive numbers. Unrelated to 6's being a perfect number, a Golomb ruler of length 6 is a "perfect ruler". Six is a con ...
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Medical Device
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. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (F ...
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Static Program Analysis
In computer science, static program analysis (or static analysis) is the analysis of computer programs performed without executing them, in contrast with dynamic program analysis, which is performed on programs during their execution. The term is usually applied to analysis performed by an automated tool, with human analysis typically being called "program understanding", program comprehension, or code review. In the last of these, software inspection and software walkthroughs are also used. In most cases the analysis is performed on some version of a program's source code, and, in other cases, on some form of its object code. Rationale The sophistication of the analysis performed by tools varies from those that only consider the behaviour of individual statements and declarations, to those that include the complete source code of a program in their analysis. The uses of the information obtained from the analysis vary from highlighting possible coding errors (e.g., the lint t ...
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