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 .
84-448: There are different types of technical or engineering specifications (specs), and the term is used differently in different technical contexts. They often refer to particular documents, and/or particular information within them. The word specification is broadly defined as "to state explicitly or in detail" or "to be specific". A requirement specification is a documented requirement , or set of documented requirements, to be satisfied by
168-589: A bill of materials . This type of specification is a collaborative effort between a specification writer and a quantity surveyor . This approach is unusual in North America, where each bidder performs a quantity survey on the basis of both drawings and specifications. In many countries on the European continent, content that might be described as "specifications" in the United States are covered under
252-412: A functional specification (also, functional spec or specs or functional specifications document (FSD) ) is the set of documentation that describes the behavior of a computer program or larger software system . The documentation typically describes various inputs that can be provided to the software system and how the system responds to those inputs. Web services specifications are often under
336-593: A requirement is a condition that must be satisfied for the output of a work effort to be acceptable. It is an explicit, objective, clear and often quantitative description of a condition to be satisfied by a material, design, product, or service. A specification or spec is a set of requirements that is typically used by developers in the design stage of product development and by testers in their verification process. With iterative and incremental development such as agile software development , requirements are developed in parallel with design and implementation. With
420-675: A "Structured Product Label" which drug manufacturers must by mandate use to submit electronically the information on a drug label. Recently, the ISO has made some progress in the area of food and drug standards and formal specifications for data about regulated substances through the publication of ISO 11238. In many contexts, particularly software, specifications are needed to avoid errors due to lack of compatibility, for instance, in interoperability issues. For instance, when two applications share Unicode data, but use different normal forms or use them incorrectly, in an incompatible way or without sharing
504-498: A case could be the loss or absence of vendor's documentation for legacy equipment or do-it-yourself (DIY) assemblies (e.g., cars, computers, etc.) and, therefore, users should endeavour to acquire DQ document beforehand. Each template of DQ, IQ, OQ and PQ usually can be found on the internet respectively, whereas the DIY qualifications of machinery/equipment can be assisted either by the vendor's training course materials and tutorials, or by
588-528: A given material, design, product, service, etc. It is a common early part of engineering design and product development processes in many fields. A functional specification is a kind of requirement specification, and may show functional block diagrams. A design or product specification describes the features of the solutions for the Requirement Specification, referring to either a designed solution or final produced solution. It
672-410: A government or business contract. In engineering , manufacturing , and business , it is vital for suppliers , purchasers , and users of materials, products, or services to understand and agree upon all requirements. A specification may refer to a standard which is often referenced by a contract or procurement document, or an otherwise agreed upon set of requirements (though still often used in
756-411: A high-level, and elaborating detail on a just-in-time or last responsible moment basis. Requirements are usually written as a means for communication between the different stakeholders. This means that the requirements should be easy to understand both for normal users and for developers. One common way to document a requirement is stating what the system must do. Example: 'The contractor must deliver
840-402: A major investment has been made in actually implementing the design. An alternative approach is to use provably correct refinement steps to transform a specification into a design, and ultimately into an actual implementation, that is correct by construction. In (hardware, software, or enterprise) systems development, an architectural specification is the set of documentation that describes
924-637: A minimum set of interoperability specification, errors and data loss can result. For example, Mac OS X has many components that prefer or require only decomposed characters (thus decomposed-only Unicode encoded with UTF-8 is also known as "UTF8-MAC"). In one specific instance, the combination of OS X errors handling composed characters, and the samba file- and printer-sharing software (which replaces decomposed letters with composed ones when copying file names), has led to confusing and data-destroying interoperability problems. Applications may avoid such errors by preserving input code points, and normalizing them to only
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#17327732337511008-493: A move to "greater use of performance and commercial specifications and standards" was to be introduced, which Perry saw as "one of the most important actions that [the Department of Defense] should take" at that time. The following British standards apply to specifications: A design/product specification does not necessarily prove a product to be correct or useful in every context. An item might be verified to comply with
1092-437: A national government (including its different public entities, regulatory agencies , and national laboratories and institutes), a professional association (society), a purpose-made standards organization such as ISO , or vendor-neutral developed generic requirements. It is common for one organization to refer to ( reference , call out , cite ) the standards of another. Voluntary standards may become mandatory if adopted by
1176-404: A new application software and restructuring of the computer which affects especially the pre-settings, such as on BIOS , registry , disk drive partition table , dynamically-linked (shared) libraries, or an ini file etc., have been necessary. In such a situation, the specifications of the parts/devices/software and restructuring proposals should be appended to the qualification document whether
1260-399: A product requirement could be said to specify the automation required to support a process requirement while a process requirement could be said to specify the activities required to support a product requirement. For example, a maximum development cost requirement (a process requirement) may be imposed to help achieve a maximum sales price requirement (a product requirement); a requirement that
1344-504: A product, service, or system (or portion thereof, or set thereof). A set of validation requirements (as defined by the user), specifications, and regulations may then be used as a basis for qualifying a development flow or verification flow for a product, service, or system (or portion thereof, or set thereof). Additional validation procedures also include those that are designed specifically to ensure that modifications made to an existing qualified development flow or verification flow will have
1428-505: 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 ". In reality, as quality management terms,
1512-419: A series of automated acceptance tests . Scope creep may occur from requirements moving over time. In Requirements management the alteration of requirements is allowed but if not adequately tracked or preceding steps (business goals then user requirements) are not throttled by additional oversight or handled as a cost and potential program failure, then requirements changes are easy and likely to happen. It
1596-551: A specific list of products, or "open" allowing for substitutions made by the constructor. Most construction specifications are a combination of performance-based and proprietary types, naming acceptable manufacturers and products while also specifying certain standards and design criteria that must be met. While North American specifications are usually restricted to broad descriptions of the work, European ones and Civil work can include actual work quantities, including such things as area of drywall to be built in square meters, like
1680-494: A specific material type (concrete) or a work product (steel door) of the construction work. A specific material may be covered in several locations, depending on the work result: stainless steel (for example) can be covered as a sheet material used in flashing and sheet Metal in division 07; it can be part of a finished product, such as a handrail, covered in division 05; or it can be a component of building hardware, covered in division 08. The original listing of specification divisions
1764-402: A specification or stamped with a specification number: this does not, by itself, indicate that the item is fit for other, non-validated uses. The people who use the item ( engineers , trade unions , etc.) or specify the item ( building codes , government, industry, etc.) have the responsibility to consider the choice of available specifications, specify the correct one, enforce compliance, and use
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#17327732337511848-667: A system for it to have value and utility to a customer, organization, user, or other stakeholder. The term requirement has been in use in the software engineering community since at least the 1960s. According to the Guide to the Business Analysis Body of Knowledge® version 2 from IIBA (BABOK), a requirement is: This definition is based on IEEE 610.12-1990: IEEE Standard Glossary of Software Engineering Terminology. Requirements can be said to relate to two fields: Product and process requirements are closely linked;
1932-417: A vendor or by the user, by confirming through review and testing that the equipment meets the written acquisition specification. If the relevant document or manuals of machinery/equipment are provided by vendors, the later 3Q needs to be thoroughly performed by the users who work in an industrial regulatory environment. Otherwise, the process of IQ, OQ and PQ is the task of validation. The typical example of such
2016-460: Is a mathematical description of software or hardware that may be used to develop an implementation . It describes what the system should do, not (necessarily) how the system should do it. Given such a specification, it is possible to use formal verification techniques to demonstrate that a candidate system design is correct with respect to that specification. This has the advantage that incorrect candidate system designs can be revised before
2100-552: Is a process for dealing with observations that are out-of-specification. The United States Food and Drug Administration has published a non-binding recommendation that addresses just this point. At the present time, much of the information and regulations concerning food and food products remain in a form which makes it difficult to apply automated information processing, storage and transmission methods and techniques. Data systems that can process, store and transfer information about food and food products need formal specifications for
2184-566: Is by test. If this is not the case, another verification method should be used instead (e.g. analysis, demonstration, inspection, or review of design). Certain requirements, by their very structure, are not verifiable. These include requirements that say the system must never or always exhibit a particular property. Proper testing of these requirements would require an infinite testing cycle. Such requirements must be rewritten to be verifiable. As stated above all requirements must be verifiable. Non-functional requirements, which are unverifiable at
2268-556: Is currently less fruitful and not yet put forward as an urgent agenda due to the tight restrictions of regional or national constitution. Specifications and other standards can be externally imposed as discussed above, but also internal manufacturing and quality specifications. These exist not only for the food or pharmaceutical product but also for the processing machinery , quality processes, packaging , logistics ( cold chain ), etc. and are exemplified by ISO 14134 and ISO 15609. The converse of explicit statement of specifications
2352-476: Is easy for requirement changes to occur faster than developers are able to produce work, and the effort to go backwards as a result. There are multiple taxonomies for requirements depending on which framework one is operating under. (For example, the stated standards of IEEE, vice IIBA or U.S. DoD approaches). Differing language and processes in different venues or casual speech can cause confusion and deviation from desired process. A process being run by humans
2436-437: Is entirely possible that a product passes when verified but fails when validated. This can happen when, say, a product is built as per the specifications but the specifications themselves fail to address the user's needs. Verification of machinery and equipment usually consists of design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). DQ may be performed by
2520-582: Is limited; the scheme requires a fair amount of efforts to get popularized. Validation work can generally be categorized by the following functions: The most tested attributes in validation tasks may include, but are not limited to For example, in an HPLC purity analysis of a drug substance, a standard material of the highest purity would be run before the test samples. The parameters analyzed might be (for example) % RSD of area counts for triplicate injections or chromatographic parameters checked such as retention time. The HPLC run would be considered valid if
2604-413: Is not covered by the above standards , it can be evaluated by the additional source of pharmacopoeias from other nations, from industrial specifications, or from a standardized formulary such as A similar approach is adopted by the food manufacturing, of which Codex Alimentarius ranks the highest standards, followed by regional and national standards. The coverage of food and drug standards by ISO
Specification (technical standard) - Misplaced Pages Continue
2688-492: Is often an external process. It is sometimes said that validation can be expressed by the query "Are you building the right thing?" and verification by "Are you building it right?". "Building the right thing" refers back to the user's needs, while "building it right" checks that the specifications are correctly implemented by the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance. It
2772-480: Is often used to guide fabrication/production. Sometimes the term specification is here used in connection with a data sheet (or spec sheet ), which may be confusing. A data sheet describes the technical characteristics of an item or product, often published by a manufacturer to help people choose or use the products. A data sheet is not a technical specification in the sense of informing how to produce. An " in-service " or " maintained as " specification , specifies
2856-486: Is often verified by analysis at the system level. Avionics software with its complicated safety requirements must follow the DO-178B development process. Activities that lead to the derivation of the system or software requirements. Requirements engineering may involve a feasibility study or a conceptual analysis phase of the project and requirements elicitation (gathering, understanding, reviewing, and articulating
2940-535: Is owned by the Royal Institute of British Architects (RIBA) through their commercial group RIBA Enterprises (RIBAe). NBS master specifications provide content that is broad and comprehensive, and delivered using software functionality that enables specifiers to customize the content to suit the needs of the project and to keep up to date. UK project specification types fall into two main categories prescriptive and performance. Prescriptive specifications define
3024-564: Is required). To the above some add Externally Observable, that is, the requirement specifies a characteristic of the product that is externally observable or experienced by the user. Such advocates argue that requirements that specify internal architecture, design, implementation, or testing decisions are probably constraints, and should be clearly articulated in the Constraints section of the Requirements document. The contrasting view
3108-507: Is subject to human flaws in governance, where convenience or desires or politics may lead to exceptions or outright subversion of the process and deviations from the textbook way the process is supposed to proceed. Examples include: Within the U.S. Department of Defense process, some historical examples of requirements issues are Verification and validation Verification and validation (also abbreviated as V&V ) are independent procedures that are used together for checking that
3192-401: Is that this perspective fails on two points. First, the perspective does not recognize that the user experience may be supported by requirements not perceivable by the user. For example, a requirement to present geocoded information to the user may be supported by a requirement for an interface with an external third party business partner. The interface will be imperceptible to the user, though
3276-561: Is venue dependent, in particular items that are shock sensitive and require balancing or calibration , and re-qualification needs to be conducted once the objects are relocated. The full scales of some equipment qualifications are even time dependent as consumables are used up (i.e. filters) or springs stretch out, requiring recalibration , and hence re-certification is necessary when a specified due time lapse. Re-qualification of machinery/equipment should also be conducted when replacement of parts, or coupling with another device, or installing
3360-516: The federal government and its agencies stipulates that a copy of the drawings and specifications must be kept available on a construction site. Specifications in Egypt form part of contract documents. The Housing and Building National Research Center ( HBRC ) is responsible for developing construction specifications and codes. The HBRC has published more than 15 books which cover building activities like earthworks , plastering, etc. Specifications in
3444-720: The structure , behavior , and more views of that system . A program specification is the definition of what a computer program is expected to do. It can be informal , in which case it can be considered as a user manual from a developer point of view, or formal , in which case it has a definite meaning defined in mathematical or programmatic terms. In practice, many successful specifications are written to understand and fine-tune applications that were already well-developed, although safety-critical software systems are often carefully specified prior to application development. Specifications are most important for external interfaces that must remain stable. In software development ,
Specification (technical standard) - Misplaced Pages Continue
3528-443: The waterfall model , requirements are completed before design or implementation start. Requirements are used in many engineering fields including engineering design , system engineering , software engineering , enterprise engineering , product development , and process optimization. Requirement is a relatively broad concept that can describe any necessary or desired function, attribute, capability, characteristic, or quality of
3612-416: The 50 division format, which was adopted in both the United States and Canada starting in 2004. The 16 division format is no longer considered standard, and is not supported by either CSI or CSC, or any of the subscription master specification services, data repositories, product lead systems, and the bulk of governmental agencies. The United States' Federal Acquisition Regulation governing procurement for
3696-684: The Construction Specifications Institute and the Registered Specification Writer (RSW) through Construction Specifications Canada. Specification writers may be separate entities such as sub-contractors or they may be employees of architects, engineers, or construction management companies. Specification writers frequently meet with manufacturers of building materials who seek to have their products specified on upcoming construction projects so that contractors can include their products in
3780-604: The UK are part of the contract documents that accompany and govern the construction of a building. They are prepared by construction professionals such as architects , architectural technologists , structural engineers , landscape architects and building services engineers . They are created from previous project specifications, in-house documents or master specifications such as the National Building Specification (NBS). The National Building Specification
3864-523: The United States and are usually subscription based. Specifications can be either "performance-based", whereby the specifier restricts the text to stating the performance that must be achieved by the completed work, "prescriptive" where the specifier states the specific criteria such as fabrication standards applicable to the item, or "proprietary", whereby the specifier indicates specific products, vendors and even contractors that are acceptable for each workscope. In addition, specifications can be "closed" with
3948-527: The United States and updated every two years. While there is a tendency to believe that "specifications overrule drawings" in the event of discrepancies between the text document and the drawings, the actual intent must be made explicit in the contract between the Owner and the Contractor. The standard AIA (American Institute of Architects) and EJCDC (Engineering Joint Contract Documents Committee) states that
4032-478: The application's preferred normal form for internal use. Such errors may also be avoided with algorithms normalizing both strings before any binary comparison. However errors due to file name encoding incompatibilities have always existed, due to a lack of minimum set of common specification between software hoped to be inter-operable between various file system drivers, operating systems, network protocols, and thousands of software packages. A formal specification
4116-524: The building code or municipal code. Civil and infrastructure work in the United States often includes a quantity breakdown of the work to be performed as well. Although specifications are usually issued by the architect 's office, specification writing itself is undertaken by the architect and the various engineers or by specialist specification writers. Specification writing is often a distinct professional trade, with professional certifications such as "Certified Construction Specifier" (CCS) available through
4200-452: The concept that the equipment, electronics, analytical operations and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability test parameters to be established for a particular procedure depend on the type of procedure being validated". In some cases of analytical chemistry , a system suitability test could be rather a method specific than universal. Such examples are chromatographic analysis, which
4284-455: The conditions of a system or object after years of operation, including the effects of wear and maintenance (configuration changes). Specifications are a type of technical standard that may be developed by any of various kinds of organizations, in both the public and private sectors. Example organization types include a corporation , a consortium (a small group of corporations), a trade association (an industry-wide group of corporations),
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#17327732337514368-560: The definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably. However, the PMBOK guide , a standard adopted by the Institute of Electrical and Electronics Engineers (IEEE), defines them as follows in its 4th edition: Similarly, for a Medical device , the FDA ( 21 CFR ) defines Validation and Verification as procedures that ensures that
4452-414: The device fulfil their intended purpose. ISO 9001:2015 considers Verification is intended to check that a product, service, or system meets a set of design specifications . In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results. In
4536-661: The drawings and specifications are complementary, together providing the information required for a complete facility. Many public agencies, such as the Naval Facilities Command (NAVFAC) state that the specifications overrule the drawings. This is based on the idea that words are easier for a jury (or mediator) to interpret than drawings in case of a dispute. The standard listing of construction specifications falls into 50 Divisions , or broad categories of work types and work results involved in construction. The divisions are subdivided into sections, each one addressing
4620-482: The effect of producing a product, service, or system (or portion thereof, or set thereof) that meets the initial design requirements, specifications, and regulations; these validations help to keep the flow qualified. It is a process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders. This
4704-463: The estimates leading to their proposals. In February 2015, ArCHspec went live, from ArCH (Architects Creating Homes), a nationwide American professional society of architects whose purpose is to improve residential architecture. ArCHspec was created specifically for use by licensed architects while designing SFR (Single Family Residential) architectural projects. Unlike the more commercial CSI/CSC (50+ division commercial specifications), ArCHspec utilizes
4788-406: The following characteristics are generally acknowledged. There are many more attributes to consider that contribute to the quality of requirements. If requirements are subject to rules of data integrity (for example) then accuracy/correctness and validity/authorization are also worthy attributes. Traceability confirms that the requirement set satisfies the need (no more - and no less than what
4872-505: The following scheme was devised by the International Institute of Business Analysis in their Business Analysis Body of Knowledge (see also FURPS and Types of requirements ). The characteristics of good requirements are variously stated by different writers, with each writer generally emphasizing the characteristics most appropriate to their general discussion or the specific technology domain being addressed. However,
4956-806: The industry are the IEEE and the IIBA. Both of these groups have different but similar definitions of what a requirement is. Many projects have succeeded with little or no agreement on requirements. Some evidence furthermore indicates that specifying requirements can decrease creativity and design performance Requirements hinder creativity and design because designers become overly preoccupied with provided information. More generally, some research suggests that software requirements are an illusion created by misrepresenting design decisions as requirements in situations where no real requirements are evident. Meanwhile, most agile software development methodologies question
5040-474: The item correctly. Validation of suitability is necessary. Public sector procurement rules in the European Union and United Kingdom require non-discriminatory technical specifications to be used to identify the purchasing organisation's requirements. The rules relating to public works contracts initially prohibited "technical specifications having a discriminatory effect" from 1971; this principle
5124-458: The more concise 16 traditional Divisions, plus a Division 0 (Scope & Bid Forms) and Division 17 (low voltage). Many architects, up to this point, did not provide specifications for residential designs, which is one of the reasons ArCHspec was created: to fill a void in the industry with more compact specifications for residential projects. Shorter form specifications documents suitable for residential use are also available through Arcom, and follow
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#17327732337515208-436: The need for rigorously describing software requirements upfront, which they consider a moving target. Instead, extreme programming for example describes requirements informally using user stories (short summaries fitting on an index card explaining one aspect of what the system should do), and considers it the developer's duty to directly ask the customer for clarification. Agile methodologies attempt to capture requirements in
5292-482: The needs of the stakeholders ) and requirements analysis , analysis (checking for consistency and completeness), specification (documenting the requirements) and validation (making sure the specified requirements are correct). Requirements are prone to issues of ambiguity, incompleteness, and inconsistency. Techniques such as rigorous inspection have been shown to help deal with these issues. Ambiguities, incompleteness, and inconsistencies that can be resolved in
5376-401: The non-genuine assemblies. Instead, the asset has to be recycled for non-regulatory purposes. When machinery/equipment qualification is conducted by a standard endorsed third party such as by an ISO standard accredited company for a particular division, the process is called certification. Currently, the coverage of ISO/IEC 15408 certification by an ISO/IEC 27001 accredited organization
5460-401: The organisation's current corporate objectives or priorities. Sometimes a guide or a standard operating procedure is available to help write and format a good specification. A specification might include: Specifications in North America form part of the contract documents that accompany and govern the drawings for construction of building and infrastructure projects. Specifications describe
5544-410: The parts/devices/software are genuine or not. Torres and Hyman have discussed the suitability of non-genuine parts for clinical use and provided guidelines for equipment users to select appropriate substitutes which are capable of avoiding adverse effects. In the case when genuine parts/devices/software are demanded by some of regulatory requirements, then re-qualification does not need to be conducted on
5628-407: The post-development phase, verification procedures involve regularly repeating tests devised specifically to ensure that the product, service, or system continues to meet the initial design requirements, specifications, and regulations as time progresses. It is a process that is used to evaluate whether a product, service, or system complies with regulations, specifications , or conditions imposed at
5712-443: The presentation of information obtained through the interface certainly would not. Second, a constraint limits design alternatives, whereas a requirement specifies design characteristics. To continue the example, a requirement selecting a web service interface is different from a constraint limiting design alternatives to methods compatible with a Single Sign-On architecture. All requirements should be verifiable. The most common method
5796-428: The product be maintainable (a product requirement) often is addressed by imposing requirements to follow particular development styles (e.g., object-oriented programming ), style-guides, or a review/inspection process (process requirements). Requirements are typically classified into types produced at different stages in a development progression, with the taxonomy depending on the overall model being used. For example,
5880-633: The product no later than xyz date.' Other methods include use cases and user stories . Requirements generally change with time. Once defined and approved, requirements should fall under change control . For many projects, requirements are altered before the system is complete. This is partly due to the complexity of computer software and the fact that users don't know what they want before they see it. This characteristic of requirements has led to requirements management studies and practices. There are several competing views of what requirements are and how they should be managed and used. Two leading bodies in
5964-541: The published guidance books, such as step-by-step series if the acquisition of machinery/equipment is not bundled with on- site qualification services. This kind of the DIY approach is also applicable to the qualifications of software, computer operating systems and a manufacturing process. The most important and critical task as the last step of the activity is to generating and archiving machinery/equipment qualification reports for auditing purposes, if regulatory compliances are mandatory. Qualification of machinery/equipment
6048-473: The quality and performance of building materials, using code citations and published standards, whereas the drawings or building information model (BIM) illustrates quantity and location of materials. The guiding master document of names and numbers is the latest edition of MasterFormat . This is a consensus document that is jointly sponsored by two professional organizations: Construction Specifications Canada and Construction Specifications Institute based in
6132-414: The rather voluminous commercial style of specifications too lengthy for most residential projects and therefore either produce more abbreviated specifications of their own or use ArCHspec (which was specifically created for residential projects). Master specification systems are available from multiple vendors such as Arcom, Visispec, BSD, and Spectext. These systems were created to standardize language across
6216-503: The representations of data about food and food products in order to operate effectively and efficiently. Development of formal specifications for food and drug data with the necessary and sufficient clarity and precision for use specifically by digital computing systems have begun to emerge from some government agencies and standards organizations: the United States Food and Drug Administration has published specifications for
6300-437: The requirements phase typically cost orders of magnitude less to correct than when these same issues are found in later stages of product development. Requirements analysis strives to address these issues. There is an engineering trade off to consider between requirements which are too vague, and those which are so detailed that they Agile approaches evolved as a way of overcoming these problems, by baselining requirements at
6384-476: The requirements using generic or proprietary descriptions of what is required, whereas performance specifications focus on the outcomes rather than the characteristics of the components. Specifications are an integral part of Building Information Modeling and cover the non-geometric requirements. Pharmaceutical products can usually be tested and qualified by various pharmacopoeias . Current existing pharmaceutical standards include: If any pharmaceutical product
6468-457: The run, and not just at the beginning. All system suitability standards must be passed to accept the run. In a broad way, it usually includes a test of ruggedness among inter-collaborators, or a test of robustness within an organization However, the U.S. Food and Drug Administration (FDA) has specifically defined it for its administration, as "System suitability testing is an integral part of many analytical procedures. The tests are based on
6552-421: The singular). In any case, it provides the necessary details about the specific requirements. Standards for specifications may be provided by government agencies, standards organizations ( SAE , AWS , NIST , ASTM , ISO / IEC , CEN / CENELEC , DoD , etc.), trade associations , corporations , and others. A memorandum published by William J. Perry , U.S. Defense Secretary , on 29 June 1994 announced that
6636-480: The software level, must still be kept as a documentation of customer intent. However, they may be traced to process requirements that are determined to be a practical way of meeting them. For example, a non-functional requirement to be free from backdoors may be satisfied by replacing it with a process requirement to use pair programming . Other non-functional requirements will trace to other system components and be verified at that level. For example, system reliability
6720-582: The start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process. Validation is intended to ensure a product, service, or system (or portion thereof, or set thereof) results in a product, service, or system (or portion thereof, or set thereof) that meets the operational needs of the user. For a new development flow or verification flow, validation procedures may involve modeling either flow and using simulations to predict faults or gaps that might lead to invalid or incomplete verification or development of
6804-475: The system suitability test passes and ensures the subsequent data collected for the unknown analytes are valid. For a longer HPLC run of over 20 samples, an additional system suitability standard (called a "check standard") might be run at the end or interspersed in the HPLC run and would be included in the statistical analysis. If all system suit standards pass, this ensures all samples yield acceptable data throughout
6888-425: The umbrella of a quality management system . These types of documents define how a specific document should be written, which may include, but is not limited to, the systems of a document naming, version, layout, referencing, structuring, appearance, language, copyright, hierarchy or format, etc. Very often, this kind of specifications is complemented by a designated template. Requirement In engineering ,
6972-459: Was based on the time sequence of construction, working from exterior to interior, and this logic is still somewhat followed as new materials and systems make their way into the construction process. Each section is subdivided into three distinct parts: "general", "products" and "execution". The MasterFormat and SectionFormat systems can be successfully applied to residential, commercial, civil, and industrial construction. Although many architects find
7056-432: Was extended to public supply contracts by the then European Communities' Directive 77/62/EEC coordinating procedures for the award of public supply contracts, adopted in 1976. Some organisations provide guidance on specification-writing for their staff and partners. In addition to identifying the specific attributes required of the goods or services being purchased, specifications in the public sector may also make reference to
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