Independent reviewer

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An independent reviewer is an individual who does not have direct professional responsibility for the design stage under review, assuring an independent and objective review. Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the design may overlook design errors. Thus, reviewers should not have been significantly involved in the activities under review.

Professional responsibility is the area of legal practice that encompasses the duties of attorneys to act in a professional manner, obey the law, avoid conflicts of interest, and put the interests of clients ahead of their own interests.

A review is an evaluation of a publication, service, or company such as a movie, video game, musical composition, book ; a piece of hardware like a car, home appliance, or computer; or an event or performance, such as a live music concert, play, musical theater show, dance show, or art exhibition. In addition to a critical evaluation, the review's author may assign the work a rating to indicate its relative merit. More loosely, an author may review current events, trends, or items in the news. A compilation of reviews may itself be called a review. The New York Review of Books, for instance, is a collection of essays on literature, culture, and current affairs. National Review, founded by William F. Buckley, Jr., is an influential conservative magazine, and Monthly Review is a long-running socialist periodical.

A design is a plan or specification for the construction of an object or system or for the implementation of an activity or process, or the result of that plan or specification in the form of a prototype, product or process. The verb to design expresses the process of developing a design. In some cases, the direct construction of an object without an explicit prior plan may also be considered to be a design activity. A design usually has to satisfy certain goals and constraints, may take into account aesthetic, functional, economic, or socio-political considerations, and is expected to interact with a certain environment. Major examples of designs include architectural blueprints, engineering drawings, business processes, circuit diagrams, and sewing patterns.

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US Food and Drug Administration

The US Food and Drug Administration requires that developers of medical device follow a system of design controls. A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems."

Food and Drug Administration agency of the United States Department of Health and Human Services

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

Medical device Equipment designed to aid in the diagnosis, monitoring or treatment of medical conditions

A medical device is any device intended to be used for medical purposes. Thus what differentiates a medical device from an everyday device is its intended use. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. 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.

Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory to implement such practice when designing and developing products within regulated industries.

In 21CFR820.30 section (e), it is stated that an independent reviewer is required for any design review. An independent reviewer is an individual who does not have direct professional responsibility for the design stage under review, assuring an independent and objective review. Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the design may overlook design errors. Thus, reviewers should not have been significantly involved in the activities under review.

UK Anti-terrorism law

The purpose of an independant reviewer in anti-terrorism legislation is much the same as in any design process; to ensure that those working on the project have not blinded themselves to it's faults, however, the independent reviewer also ensures that the legislation does not fall foul of anti-discrimination legislation and cause conflict in the law. [1]

Anti-terrorism legislation are laws with the purpose of fighting terrorism. They usually, if not always, follow specific bombings or assassinations. Anti-terrorism legislation usually includes specific amendments allowing the state to bypass its own legislation when fighting terrorism-related crimes, under the grounds of necessity.

Related Research Articles

A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality is increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both, and deals with quality and sustainability and their integration.

Usability the ease of use and learnability of a human-made object such as a tool or device; the degree to which a software can be used by consumers to achieve quantified objectives with effectiveness, efficiency, and satisfaction in a quantified context of use

Usability is the ease of use and learnability of a human-made object such as a tool or device. In software engineering, usability is the degree to which a software can be used by specified consumers to achieve quantified objectives with effectiveness, efficiency, and satisfaction in a quantified context of use.

An electronic lab notebook is a computer program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory. A lab notebook is often maintained to be a legal document and may be used in a court of law as evidence. Similar to an inventor's notebook, the lab notebook is also often referred to in patent prosecution and intellectual property litigation.

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes.

In business and accounting, information technology controls are specific activities performed by persons or systems designed to ensure that business objectives are met. They are a subset of an enterprise's internal control. IT control objectives relate to the confidentiality, integrity, and availability of data and the overall management of the IT function of the business enterprise. IT controls are often described in two categories: IT general controls (ITGC) and IT application controls. ITGC include controls over the Information Technology (IT) environment, computer operations, access to programs and data, program development and program changes. IT application controls refer to transaction processing controls, sometimes called "input-processing-output" controls. Information technology controls have been given increased prominence in corporations listed in the United States by the Sarbanes-Oxley Act. The COBIT Framework is a widely used framework promulgated by the IT Governance Institute, which defines a variety of ITGC and application control objectives and recommended evaluation approaches. IT departments in organizations are often led by a Chief Information Officer (CIO), who is responsible for ensuring effective information technology controls are utilized.

Business analysis is a research discipline of identifying business needs and determining solutions to business problems. Solutions often include a software-systems development component, but may also consist of process improvement, organizational change or strategic planning and policy development. The person who carries out this task is called a business analyst or BA.

Systems architect profession in information and communications technology

The systems architect is a professional figure in information and communications technology. Systems architects define the architecture of a computerized system in order to fulfill certain requirements. Such definitions include: a breakdown of the system into components, the component interactions and interfaces, and the technologies and resources to be used in the design.

Organizational architecture

Organizational architecture has two very different meanings. In one sense it literally refers to the organization's built environment and in another sense it refers to architecture metaphorically, as a structure which fleshes out the organizations. The various features of a business's organizational architecture has to be internally consistent in strategy, architecture and competitive environment.

A non-executive director, independent director or external director is a member of the board of directors of a company or organisation, but not a member of the executive management team. They are not employees of the company or affiliated with it in any other way and are differentiated from executive directors, who are members of the board who also serve, or previously served, as executive managers of the company. However they do have the same legal duties, responsibilities and potential liabilities as their executive counterparts.

Interim management is the temporary provision of management resources and skills. Interim management can be seen as the short-term assignment of a proven heavyweight interim executive manager to manage a period of transition, crisis or change within an organization. In this situation, a permanent role may be unnecessary or impossible to find on short notice. Additionally, there may be nobody internally who is suitable for, or available to take up, the position in question.

A software review is "A process or meeting during which a software product is examined by a project personnel, managers, users, customers, user representatives, or other interested parties for comment or approval".

The Joint Capabilities Integration and Development System (JCIDS), is the formal United States Department of Defense (DoD) process which defines acquisition requirements and evaluation criteria for future defense programs. JCIDS was created to replace the previous service-specific requirements generation system that allowed redundancies in capabilities and failed to meet the combined needs of all US military services. In order to correct these problems, JCIDS is intended to guide the development of requirements for future acquisition systems to reflect the needs of all four services by focusing the requirements generation process on needed capabilities as requested or defined by one of the US combatant commanders. In an ideal implementation of the JCIDS process, regional and functional combatant commanders give early and continuous feedback into the acquisition and sustainment processes to ensure their current and evolving requirements are known and met.

Project governance is the management framework within which project decisions are made. Project governance is a critical element of any project, since the accountabilities and responsibilities associated with an organization’s business as usual activities are laid down in their organizational governance arrangements; seldom does an equivalent framework exist to govern the development of its capital investments (projects). For instance, the organization chart provides a good indication of who in the organization is responsible for any particular operational activity the organization conducts. But unless an organization has specifically developed a project governance policy, no such chart is likely to exist for project development activity.

Software security assurance is a process that helps design and implement software that protects the data and resources contained in and controlled by that software. Software is itself a resource and thus must be afforded appropriate security.

Strategic communication can mean either communicating a concept, a process, or data that satisfies a long term strategic goal of an organization by allowing facilitation of advanced planning, or communicating over long distances usually using international telecommunications or dedicated global network assets to coordinate actions and activities of operationally significant commercial, non-commercial and military business or combat and logistic subunits. It can also mean the related function within an organization, which handles internal and external communication processes. Strategic communication can also be used for political warfare.

The engineering design process is a methodical series of steps that engineers use in creating functional products and processes. The process is highly iterative - parts of the process often need to be repeated many times before another can be entered - though the part(s) that get iterated and the number of such cycles in any given project may vary.

…It is a decision making process in which the basic sciences, mathematics, and engineering sciences are applied to convert resources optimally to meet a stated objective. Among the fundamental elements of the design process are the establishment of objectives and criteria, synthesis, analysis, construction, testing and evaluation.

In the United States military integrated acquisition lifecycle the Technical section has multiple acquisition "Technical Reviews". Technical reviews and audits assist the acquisition and the number and types are tailored to the acquisition. Overall guidance flows from the Defense Acquisition Guidebook chapter 4, with local details further defined by the review organizations. Typical topics examined include adequacy of program/contract metrics, proper staffing, risks, budget, and schedule.

Business requirements, also known as stakeholder requirements specifications (StRS), describe the characteristics of a proposed system from the viewpoint of the system's end user like a CONOPS. Products, systems, software, and processes are ways of how to deliver, satisfy, or meet business requirements. Consequently, business requirements are often discussed in the context of developing or procuring software or other systems.

Doron Menashe

Prof. Doron Menashe, J.S.D is an associate professor of law, in the Faculty of Law at the University of Haifa, Editor-in-Chief of Haifa Law Review, one of the leading law reviews in Israel, Mediator and Arbitrator in the Institute of Commercial Arbitration and head of the master's program in adjudication and criminal procedure. He is also a member of the International Society for Therapeutic Jurisprudence.

References

  1. https://terrorismlegislationreviewer.independent.gov.uk/