170:
involve modeling either flow and using simulations to predict faults or gaps that might lead to invalid or incomplete verification or development of 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 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 is often an external process.
447:
The HPLC run would be considered valid if 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 the run, and not just at the beginning. All system suitability standards must be passed to accept the run.
458:(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 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
462:, a system suitability test could be rather a method specific than universal. Such examples are chromatographic analysis, which is usually media (column, paper or mobile solvent) sensitive However to the date of this writing, this kind of approaches are limited to some of pharmaceutical compendial methods, by which the detecting of impurities, or the quality of the intest analyzed are critical (i.e., life and death). This is probably largely due to:
187:
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 a case could be the loss or absence of vendor's documentation for legacy equipment or
232:
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 the non-genuine assemblies. Instead, the asset has to be recycled for non-regulatory purposes.
191:(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 the published guidance books, such as
446:
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.
441:
System suitability – A test run each time an analysis is performed to ensure the test method is acceptable and is performing as written. This type of check is often run in a QC Lab. Usually, system suitability is performed by analyzing a standard material (House standard or reference standard) before
231:
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 the parts/devices/software are genuine or not. Torres and Hyman have discussed the suitability of non-genuine parts for
133:
Verification: Design verification is confirmation by examination and provision of objective evidence that the specified input requirements have been fulfilled. Verification activities such as modelling, simulations, alternative calculations, comparison with other proven designs, experiments, tests,
836:
There are some authors who apparently regard these two terms as synonymous, others who seem to be only vaguely aware of the differences. Some even appear to believe that V&V is one word! ... There is such a fundamental difference between these models that the term validation has many years ago
195:
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
173:
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
169:
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
186:
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 a vendor or by the user, by confirming through review and testing that the equipment
259:
Prospective validation – the missions conducted before new items are released to make sure the characteristics of the interests which are functioning properly and which meet safety standards. Some examples could be legislative rules, guidelines or proposals, methods, theories/hypothesis/models,
263:
Retrospective validation – a process for items that are already in use and distribution or production. The validation is performed against the written specifications or predetermined expectations, based upon their historical data/evidences that are documented/recorded. If any critical data is
156:
or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results. In the post-development phase, verification procedures involve regularly repeating tests devised specifically to ensure that the product, service, or system
129:
Validation: To ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Design validation is similar to verification, except this time you should check the designed product under conditions of actual
308:
Re-validation/locational or periodical validation – carried out, for the item of interest that is dismissed, repaired, integrated/coupled, relocated, or after a specified time lapse. Examples of this category could be relicensing/renewing driver's license, recertifying an
2459:
Li, Yong-guo; Chen, M; Chou, GX; Wang, ZT; Hu, ZB; et al. (2004). "Ruggedness/robustness evaluation and system suitability test on United States
Pharmacopoeia XXVI assay ginsenosides in Asian and American ginseng by high-performance liquid chromatography".
299:
Partial validation – often used for research and pilot studies if time is constrained. The most important and significant effects are tested. From an analytical chemistry perspective, those effects are selectivity, accuracy, repeatability, linearity and its
65:. 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 "
3242:
1351:
Sangiovanni, A.; Manini, M; Iavarone, M; Fraquelli, M; Forzenigo, L; Romeo, R; Ronchi, G; Colombo, M; et al. (2007). "Prospective validation of AASLD guidelines for the early diagnosis of epatocellular carcinoma in cirrhotic patients".
532:
management. The aspects of validation and verification are even more intense and emphasized if an OOS occurs. Very often under this circumstance, a multiplicated sample analysis is required for conducting the OOS investigation in a testing
1024:
std 24765:2010(E), 2010. | verification 6. ...comply with requirements (e.g., for correctness, completeness, consistency, and accuracy) for all life cycle activities during each life cycle process (acquisition, supply, development,
2634:"Current challenges for FDA-regulated bioanalytical laboratories for human (BA/BE) studies. Part I: defining the appropriate compliance standards – application of the principles of FDA GLP and FDA GMP to bioanalytical laboratories"
518:
The design, production, and distribution of drugs are highly regulated. This includes software systems. For example, in the US, the Food and Drug
Administration have regulations in Part 21 of the Code of Federal Regulations. Nash
177:
It 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.
2395:
Szsz, Gy.; Gyimesi-Forrás, K.; Budvári-Bárány, Zs.; et al. (1998). "Optimized and
Validated HPLC Methods for Compendial Quality Assessment. III. Testing of Optical Purity Applying 1-Acid-Glycoprotein Stationary Phase".
211:, 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 a new
2139:
313:
that has been expired or relocated, and even revalidating professionals. Re-validation may also be conducted when/where a change occurs during the courses of activities, such as scientific researches or phases of
91:"Validation. The assurance that a product, service, or system meets the needs of the customer and other identified stakeholders. It often involves acceptance and suitability with external customers. Contrast with
894:
In interviews most of the interviewers are asking questions on "What is
Difference between Verification and Validation?" Lots of people use verification and validation interchangeably but both have different
157:
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,
1563:
Ames, D.; Keogh, A.M.; Adams, J.; Harrigan, S.; Allen, N.; et al. (1996). "Prospective validation of the EBAS-DEP – A short sensitive screening instrument for depression in the physically ill elderly".
523:
have published a book which provides a comprehensive coverage on the various validation topics of pharmaceutical manufacturing processes. Some companies are taking a risk-based approach to validating their
485:
These terms generally apply broadly across industries and institutions. In addition, they may have very specific meanings and requirements for specific products, regulations, and industries. Some examples:
203:, 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
98:"Verification. The evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition. It is often an internal process. Contrast with
3149:
Haboudane, Driss; et al. (2004). "Hyperspectral vegetation indices and novel algorithms for predicting green LAI of crop canopies: Modeling and validation in the context of precision agriculture".
3246:
2757:"Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices"
2547:
Moradi, Mehrdad, Bentley James Oakes, Mustafa
Saraoglu, Andrey Morozov, Klaus Janschek, and Joachim Denil. "Exploring Fault Parameter Space Using Reinforcement Learning-based Fault Injection." (2020).
1487:
Pfisterer, Matthias; et al. (2008). "Drug-eluting or bare-metal stents forlarge coronary vessel stenting? The BASKET-PROVE (PROspective
Validation Examination) trial: Study protocol and design".
3097:"Verification of genetic recombination by hypha fusion of Pyricularia oryzas using transducing gene as marker. (the Ministry of Agriculture, Forestry and Fisheries Natl. Agricultural Res. Center S)"
865:
Two terms that sometimes confuse software test engineers are "validation" and "verification". ... Obviously the two IEEE definitions are so close to each other it's hard to determine the difference.
1178:
2259:
1655:
774:
908:"P1490/D1, May 2011 - IEEE Draft Guide: Adoption of the Project Management Institute (PMI) Standard: A Guide to the Project Management Body of Knowledge (PMBOK Guide)-2008 (4th edition)"
2135:
1842:
1312:
Quinn, James; McDermott, D; Stiell, I; Kohn, M; Wells, G; et al. (2006). "Prospective
Validation of the San Francisco Syncope Rule to Predict Patients With Serious Outcomes".
955:
1953:
Bressolle, Françoise; Brometpetit, M; Audran, M; et al. (1996). "Validation of liquid chromatographic and gas chromatographic methods
Applications to pharmacokinetics".
476:
To solve this kind of difficulty, some regulatory bodies or methods provide advice on when performing of a specified system suitability test should be applied and compulsory.
80:
442:
the unknowns are run in an analytical method. Statistical analysis and other parameters must pass preset conditions to ensure the method and system are performing correctly.
1713:
Hart, D.; S.W. Smith (2007). "Retrospective
Validation of a Clinical Decision Rule to Safely Rule Out Subarachnoid Hemorrhage in Emergency Department Headache Patients".
84:
1989:
837:
been selected to be different from the term verification. Nevertheless, it is debatable whether the distinction between validation and verification should be continued.
2785:
2560:
1256:
20:
2922:
236:
1921:
3329:
548:
1524:"Improvement in the regulation of the vitamin K antagonist acenocoumarol after a standard initial dose regimen: prospective validation of a prescription model"
2819:
2734:
2676:
2194:
1065:
555:
455:
161:, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process.
542:
111:
3213:"Monitoring the Realization of the Right to Food: Adaptation and Validation of the U.S. Department of Agriculture Food Insecurity Module to Rural Senegal"
1687:
1286:
3000:
2954:
2266:
174:
the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.
980:
std 24765:2010(E), 2010. | verification 5. ...product, service, or system complies with a regulation, requirement, specification, or imposed condition.
1047:
1017:
973:
196:
the activity is to generating and archiving machinery/equipment qualification reports for auditing purposes, if regulatory compliances are mandatory.
1791:"How to evaluate and improve the quality and credibility of an outcomes database: validation and feedback study on the UK Cardiac Surgery Experience"
3372:
3096:
570:: ISO 15198:2004 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer
809:
303:
3302:
3297:
1917:
2427:
3281:
3049:
2591:
2347:
1838:
1085:
525:
333:
out-of-specification] (OOS) investigations, due to the contamination of testing reagents, glasswares, the aging of equipment/devices, or the
3124:"Implications of the Voluntary Michigan Agriculture Environmental Assurance Program (MAEAP) Verification on Livestock Operations, 2000–2004"
2756:
2727:
2698:
749:
496:
27:
1384:
528:
system if one understands the regulatory requirements very well while the most of others follows the conventional process It is a part of
2523:"Optimizing fault injection in FMI co-simulation through sensitivity partitioning | Proceedings of the 2019 Summer Simulation Conference"
1846:
1227:
373:
Concurrent validation – conducted during a routine processing of services, manufacturing or engineering etc. Examples of these could be
2864:
1522:
Van Geest-Daalderop, Johanna H. H.; Hutten, Barbara A.; Péquériaux, Nathalie C. V.; Levi, Marcel; Sturk, Augueste; et al. (2008).
2669:
2198:
545:) has validation and verification requirements for medical devices, as outlined in ASME V&V 40. Also see guidance: and ISO 13485.
54:
3123:
2890:
2608:
3322:
1651:
1260:
1200:
704:
2086:
Tollman, Stephen M; Kahn, Kathleen; Sartorius, Benn; Collinson, Mark A; Clark, Samuel J; Garenne, Michel L; et al. (2008).
357:
199:
Qualification of machinery/equipment is venue dependent, in particular items that are shock sensitive and require balancing or
270:
the change of legislative regulations or standards affects the compliance of the items being released to the public or market.
3489:
3382:
3357:
3191:"Using cross-validation to evaluate ceres-maize yield simulations within a decision support system for precision agriculture"
3014:
1993:
118:
Validation: Ensuring that the device meets the needs and requirements of its intended users and the intended use environment.
2793:
2568:
1264:
1151:
2929:
2088:"Implications of mortality transition for primary health care in rural South Africa: a population-based surveillance study"
2016:
1922:"Guidelines for the Validation of Analytical Methods for Active Constituent, Agricultural and Veterinary Chemical Products"
3448:
3362:
512:
76:
terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably.
2229:
3741:
3710:
3315:
2789:
2763:
2705:
2206:
2147:
1664:
754:
679:– applications vary from verifying agricultural methodology and production processes to validating agricultural modeling
2968:
626:: ISO 14064 ANSI/ISO: Greenhouse gases – Requirements for greenhouse gas validation and verification bodies for use in
389:
single sample analysis for a chemical assay by a skilled operator with multiplicated online system suitability testings
264:
missing, then the work can not be processed or can only be completed partially. The tasks are considered necessary if:
239:
standard accredited company for a particular division, the process is called certification. Currently, the coverage of
3746:
3731:
3525:
2428:"System suitability testing for Aripiprazole quality control with the Agilent 1120 Compact LC and ZORBAX C-18 columns"
1928:
877:
583:
404:
3190:
2291:
Heyden, Y. Vander; S.W. Smith; et al. (2001). "Guidance for robustness/ruggedness tests in method validation".
2017:"Downstream Processing: A Revalidation Study of Viral Clearance in the Purification of Monoclonal Antibody CB.Hep-1"
1742:"Retrospective Validation of a Surveillance System for Unexplained Illness and Death: New Haven County, Connecticut"
3387:
2865:"A review of current implementation strategies for validation of cleaning processes in the pharmaceutical industry"
361:
3034:
Sixteenth Annual
Battery Conference on Applications and Advances. Proceedings of the Conference (Cat. No.01TH8533)
3032:
Manzo, M.A.; Strawn, D.M.; Hall, S.W. (7 August 2002). "Aerospace nickel-cadmium cell verification-final report".
2173:
3535:
3520:
2255:
114:) defines Validation and Verification as procedures that ensures that the device fulfil their intended purpose.
58:
3736:
3550:
3428:
3423:
3367:
1691:
1290:
1072:. Lecture Notes in Computer Science. Vol. 11615. Cham: Springer International Publishing. pp. 71–90.
345:
3073:
1605:"Identifying Stroke in the Field: Prospective Validation of the Los Angeles Prehospital Stroke Screen (LAPSS)"
853:
3397:
3392:
2699:"Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
2670:"Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"
729:
430:
2496:
3672:
3377:
769:
409:
353:
208:
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49:) are independent procedures that are used together for checking that a product, service, or system meets
3606:
3576:
3352:
3100:
1461:
1428:"Rapid Identification of High-Risk Transient Ischemic Attacks: Prospective Validation of the ABCD Score"
935:
682:
365:
2815:
1604:
820:
3751:
3697:
3667:
3163:
2645:
459:
247:
accredited organization is limited; the scheme requires a fair amount of efforts to get popularized.
235:
When machinery/equipment qualification is conducted by a standard endorsed third party such as by an
224:
212:
149:
2039:"Evaluating Predictors of Geographic Area Population Size Cut-offs to Manage Re-identification Risk"
3677:
3662:
3631:
3338:
2891:"Discussion Paper on Proposed Draft Guidelines for the Validation of Food Hygiene Control Measures"
2434:
724:
3687:
3682:
3433:
3402:
3055:
2316:
1585:
1385:"Prospective validation of the WHO proposals for the classification of myelodysplastic syndromes"
1231:
1091:
849:
744:
641:
450:
In a broad way, it usually includes a test of ruggedness among inter-collaborators, or a test of
348:
accredited laboratories, verification/revalidation will even be conducted very often against the
310:
73:
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2477:
2368:
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1204:
3167:
1603:
Kidwell, Chelsea S.; Starkman, S; Eckstein, M; Weems, K; Saver, JL; et al. (2000).
368:
etc to cater for national needs. These laboratories must have method validation as well.
215:
and restructuring of the computer which affects especially the pre-settings, such as on
152:. In the development phase, verification procedures involve performing special tests to
3621:
3611:
3566:
3510:
3407:
3274:
Practical examples on traceability, measurement uncertainty and validation in chemistry
2112:
2087:
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759:
709:
686:
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505:
315:
188:
107:
2728:"General Principles of Software validation; Final Guidance for Industry and FDA Staff"
2304:
2103:
1966:
1815:
1790:
1726:
1329:
3725:
3601:
3596:
3571:
3443:
3059:
2522:
2169:
1843:"The White Paper Trust, assurance and safety: The regulation of health professionals"
1581:
1095:
810:"Everything You Thought You Knew about Validation and Verification is Probably Dodgy"
714:
627:
435:
414:
244:
240:
204:
158:
34:
2320:
1589:
148:
Verification is intended to check that a product, service, or system meets a set of
3636:
691:
400:
The most tested attributes in validation tasks may include, but are not limited to
334:
3018:
554:
Manufacturing process and cleaning validation are compulsory and regulated by the
1885:
1444:
1427:
1155:
919:
1111:
1077:
676:
617:
575:
471:
their confinements by the definition of the term defined by different standards.
50:
2473:
907:
382:
triplicated sample analysis for trace impurities at the marginalized levels of
3626:
3175:
2409:
2233:
1540:
1523:
1500:
1369:
671:
327:
121:
Verification: Ensuring that the device meets its specified design requirements
57:
and that it fulfills its intended purpose. These are critical components of a
3212:
3041:
1066:"Model-Implemented Hybrid Fault Injection for Simulink (Tool Demonstrations)"
2975:
2339:
1806:
734:
666:
349:
2481:
2312:
2121:
2072:
1903:
1824:
1775:
1757:
1630:
1621:
1549:
1508:
1453:
1400:
1337:
2609:"Risk-based equipment qualification: a user/supplier cooperative approach"
2363:"Calibration of dissolution test apparatus (USP apparatus 1 and 2) – SOP".
1974:
3159:
1573:
1361:
1321:
1129:
1064:
Moradi, Mehrdad; Van Acker, Bert; Vanherpen, Ken; Denil, Joachim (2019).
649:
595:
567:
490:
255:
Validation work can generally be categorized by the following functions:
228:
62:
2054:
3484:
2423:
3307:
2336:
Method Validation in Pharmaceutical Analysis: A Guide to best Practice
3474:
607:
2654:
2633:
2174:"Validation Guidelines for Pharmaceutical Dosage Forms (GUIDE-0029)"
377:
153:
2584:
Pharmaceutical Process Validation: An International Third Edition
3515:
2500:
1426:
Sciolla, Rossella; Melis, F; Sinpac, Group; et al. (2008).
1051:
1021:
999:
977:
911:
601:
560:
216:
3311:
1068:. In Chamberlain, Roger; Taha, Walid; Törngren, Martin (eds.).
2632:
Ocampo, Arlene; Lum, Steven; Chow, Frank; et al. (2007).
2037:
El Eman, Khaled; Brown, A; Abdelmalik, P; et al. (2009).
1054:
std 24765:2010(E), 2010. | validation (especially 1. & 2.)
1043:
1013:
969:
529:
2260:"Guidance Notes on Analytical Method Validation: Methodology"
19:"IV&V" redirects here. For NASA's IV&V Facility, see
2398:
Journal of Liquid Chromatography & Related Technologies
1918:
Australian Pesticides & Veterinary Medicines Authority
1179:"Replacement Parts-Identical, Suitable, or Inappropriate?"
3074:"Improving the efficiency of verification and validation"
775:
Verification and validation of computer simulation models
3298:
Maturity of verification and validation in ICT companies
3243:"Method and system for authenticating appraisal reports"
2199:"Guidance for Industry: Bioanalytical Method Validation"
796:
Quality Management Systems - Process Validation Guidance
267:
prospective validation is missing, inadequate or flawed.
2816:"Guide to inspections validation of cleaning processes"
2786:"Guideline on general principles of process validation"
2561:"GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION"
2136:
United States Department of Health & Human Services
2092:
Journal of the American Medical Informatics Association
2043:
Journal of the American Medical Informatics Association
1257:"Guideline on general principles of process validation"
468:
their intensive labouring demands and time consumption
2843:"Cleaning validation in the pharmaceutical industry"
87:(IEEE), defines them as follows in its 4th edition:
3655:
3559:
3498:
3457:
3416:
3345:
3303:Organisational maturity and functional performance
2555:
2553:
2462:Journal of Pharmaceutical and Biomedical Analysis
2293:Journal of Pharmaceutical and Biomedical Analysis
1042:"Systems and software engineering - Vocabulary,"
1012:"Systems and software engineering - Vocabulary,"
968:"Systems and software engineering - Vocabulary,"
85:Institute of Electrical and Electronics Engineers
878:"Difference between Verification and Validation"
318:transitions. Examples of these changes could be
21:Independent Verification and Validation Facility
16:Methods for checking conformance to requirements
227:, dynamically-linked (shared) libraries, or an
954:CS1 maint: DOI inactive as of September 2024 (
3323:
3211:Randolph, Susan; et al. (October 2007).
1228:"AppLabs attains ISO27001:2005 accreditation"
1177:Torres, Rebecca E.; William A. Hyman (2007).
817:12th INCOSE SA Systems Engineering Conference
549:Validation and verification (medical devices)
280:Some of the examples could be validation of:
8:
3276:. Vol. 1. European Union. p. 217.
2334:Ermer, Joachim; John H. McB. Miller (2005).
283:ancient scriptures that remain controversial
990:
988:
986:
3330:
3316:
3308:
3122:Vollmer-Sanders, Carrie Lynn; et al.
1438:(2). American Heart Association: 297–302.
1070:Cyber Physical Systems. Model-Based Design
376:duplicated sample analysis for a chemical
2863:Bharadia, Praful D.; Jignyasha A. Bhatt.
2653:
2111:
2062:
1893:
1880:(4). Royal College of Physicians: 371–6.
1814:
1765:
1620:
1539:
1443:
3373:Earth systems engineering and management
1740:Kluger, Michael D.; et al. (2001).
1615:(1). American Heart Association: 71–76.
1251:
1249:
1107:
1105:
798:(GHTF/SG3/N99-10:2004 (Edition 2) page 3
396:Aspects of analytical methods validation
1128:Analytical & Precision Balance Co.
787:
2999:: CS1 maint: archived copy as title (
2992:
2953:: CS1 maint: archived copy as title (
2946:
2377:
2366:
1528:Journal of Thrombosis and Thrombolysis
1469:
1459:
944:
933:
3241:Pruitt, Kirk; Ryan Paul Chamberlain.
2582:Nash, Robert A.; et al. (2003).
1658:Medical Device Quality Systems Manual
7:
1495:(4). Mosby-Year Book Inc.: 609–614.
750:Software verification and validation
497:Software verification and validation
454:within an organization However, the
360:to cater for multinational needs or
28:software verification and validation
3152:Accreditation and Quality Assurance
2586:. Informa Healthcare. p. 860.
2140:"Warning Letter (WL No. 320-08-04)"
1789:Fine, Leon G.; et al. (2003).
2015:del Rosario Alemán, MarĂa (2007).
1870:"Physician revalidation in Europe"
794:Global Harmonization Task Force -
14:
3408:Sociocultural Systems Engineering
1746:American Journal of Public Health
1727:10.1016/j.annemergmed.2007.06.388
1652:U.S. Food and Drug Administration
1383:Germing, U.; et al. (2006).
1330:10.1016/j.annemergmed.2005.11.019
1261:U.S. Food and Drug Administration
1201:"ISV, IHV Certification Programs"
642:Periodic motor vehicle inspection
556:U.S. Food and Drug Administration
456:U.S. Food and Drug Administration
134:and specialist technical reviews.
26:For the software activities, see
1289:. Groupe Novasep. Archived from
705:Certification of voting machines
3272:Majcen, N.; Taylor, P. (2010).
427:– especially for trace elements
3490:Systems development life cycle
3383:Enterprise systems engineering
3358:Biological systems engineering
3217:Economic Rights Working Papers
2607:De Caris, Sandro; et al.
1116:Software Engineering Economics
1:
3449:System of systems engineering
3363:Cognitive systems engineering
2638:The Quality Assurance Journal
2305:10.1016/S0731-7085(00)00529-X
2104:10.1016/S0140-6736(08)61399-9
1990:"Commercial scale production"
1967:10.1016/S0378-4347(96)00088-6
1656:"Ch. 4 PROCESS VALIDATION in
854:"Validation vs. Verification"
630:or other forms of recognition
513:Validation (drug manufacture)
386:, or/and quantification limit
273:reviving of out-of-use items.
33:For validation of tests, see
2820:Food and Drug Administration
2790:Food and Drug Administration
2764:Food and Drug Administration
2735:Food and Drug Administration
2706:Food and Drug Administration
2677:Food and Drug Administration
2207:Food and Drug Administration
2195:Food and Drug Administration
2148:Food and Drug Administration
1886:10.7861/clinmedicine.8-4-371
1715:Annals of Emergency Medicine
1665:Food and Drug Administration
1582:10.1016/0924-9338(96)89148-6
1445:10.1161/STROKEAHA.107.496612
1314:Annals of Emergency Medicine
922:(inactive 12 September 2024)
920:10.1109/IEEESTD.2011.5937011
755:Statistical model validation
502:Food and drug manufacturing
83:, a standard adopted by the
3526:Quality function deployment
3439:Verification and validation
1955:Journal of Chromatography B
1354:Digestive and Liver Disease
1078:10.1007/978-3-030-23703-5_4
584:Engineering validation test
405:Sensitivity and specificity
43:Verification and validation
3768:
3388:Health systems engineering
3189:Thorp, Kelly; et al.
2792:. May 1987. Archived from
2567:. May 1987. Archived from
2474:10.1016/j.jpba.2004.04.005
2299:(5–6). Elsevier: 723–753.
1688:"Retrospective validation"
546:
510:
494:
225:disk drive partition table
32:
25:
18:
3706:
3536:Systems Modeling Language
3176:10.1016/j.rse.2003.12.013
2410:10.1080/10826079808003597
2256:Health Sciences Authority
1988:Peptisyntha S.A. (2009).
1541:10.1007/s11239-008-0203-4
1501:10.1016/j.ahj.2007.11.011
1370:10.1016/j.dld.2007.12.064
337:of associated assets etc.
125:ISO 9001:2015 considers
59:quality management system
3551:Work breakdown structure
3429:Functional specification
3424:Requirements engineering
3368:Configuration management
3042:10.1109/BCAA.2001.905101
2497:"Japanese Pharmacopoeia"
1287:"Prospective validation"
646:Aircraft noise: example
251:Categories of validation
3398:Reliability engineering
3393:Performance engineering
1868:Merkur, Sherry (2008).
1807:10.1136/bmj.326.7379.25
1534:(2). Springer: 207–14.
730:Functional verification
660:(Ni-Cd) cells: example
580:Engineering in general
431:Limit of quantification
286:clinical decision rules
3673:Industrial engineering
3378:Electrical engineering
1758:10.2105/AJPH.91.8.1214
1622:10.1161/01.str.31.1.71
1489:American Heart Journal
1152:"External Calibration"
943:Cite journal requires
882:Software Testing Class
770:Validation master plan
685:– audit reporting and
663:ICT Industry: example
633:Traffic and transport
410:Accuracy and precision
260:products and services.
3607:Arthur David Hall III
3577:Benjamin S. Blanchard
3353:Aerospace engineering
3015:"Service Unavailable"
2646:John Wiley & Sons
683:Real estate appraisal
547:Further information:
493:and computer systems
296:Full-scale validation
150:design specifications
45:(also abbreviated as
3698:Software engineering
3668:Computer engineering
2981:on 27 September 2007
2529:: 1–12. 22 July 2019
2236:on 11 September 2011
1839:Department of Health
808:Ad Sparrius (2016).
782:Notes and references
566:Clinical laboratory
460:analytical chemistry
243:certification by an
213:application software
3742:Systems engineering
3678:Operations research
3663:Control engineering
3632:Joseph Francis Shea
3339:Systems engineering
3168:2004RSEnv..90..337H
3103:on 17 February 2012
3095:Masako, Tsujimoto.
3021:on 13 October 2007.
2766:. 25 September 2006
2272:on 18 February 2012
2230:"Method Validation"
2227:Method Validation;
2055:10.1197/jamia.M2902
1934:on 20 February 2011
1694:on 15 November 2008
1566:European Psychiatry
1407:on 12 November 2010
1293:on 15 November 2008
1207:on 16 February 2008
725:Formal verification
481:Industry references
3747:Drug manufacturing
3732:Quality management
3688:Quality management
3683:Project management
3511:Function modelling
3434:System integration
3403:Safety engineering
3076:. Inderscience.com
3036:. pp. 59–66.
2935:on 12 October 2007
2903:on 11 October 2010
2841:Nassani, Mowafak.
2440:on 5 February 2015
1472:has generic name (
1158:on 29 January 2020
914:. June 2011: 452.
850:James D. McCaffrey
745:Process validation
425:Limit of detection
330:profiles and sizes
311:analytical balance
74:quality management
3719:
3718:
3642:Manuela M. Veloso
3582:Wernher von Braun
3283:978-92-79-12021-3
3051:978-0-7803-6545-2
2737:. 11 January 2002
2708:. 14 January 2005
2593:978-0-8247-0838-2
2404:(16): 2535–2547.
2376:Missing or empty
2349:978-3-527-31255-9
2098:(9642): 893–901.
1874:Clinical Medicine
1849:on 5 October 2012
1395:(12): 1596–1604.
1087:978-3-030-23703-5
1002:, 2004, p. 9
852:(28 April 2006).
765:Usability testing
637:Road safety audit
591:Civil engineering
563:hygiene: example
324:production scales
106:Similarly, for a
3759:
3647:John N. Warfield
3617:Robert E. Machol
3546:Systems modeling
3541:Systems analysis
3480:System lifecycle
3465:Business process
3332:
3325:
3318:
3309:
3287:
3259:
3258:
3256:
3254:
3245:. Archived from
3238:
3232:
3231:
3229:
3227:
3208:
3202:
3201:
3199:
3197:
3186:
3180:
3179:
3146:
3140:
3139:
3137:
3135:
3126:. Archived from
3119:
3113:
3112:
3110:
3108:
3099:. Archived from
3092:
3086:
3085:
3083:
3081:
3070:
3064:
3063:
3029:
3023:
3022:
3017:. Archived from
3011:
3005:
3004:
2998:
2990:
2988:
2986:
2980:
2974:. Archived from
2973:
2965:
2959:
2958:
2952:
2944:
2942:
2940:
2934:
2928:. Archived from
2927:
2919:
2913:
2912:
2910:
2908:
2902:
2896:. Archived from
2895:
2887:
2881:
2880:
2878:
2876:
2867:. Archived from
2860:
2854:
2853:
2851:
2849:
2838:
2832:
2831:
2829:
2827:
2812:
2806:
2805:
2803:
2801:
2782:
2776:
2775:
2773:
2771:
2761:
2753:
2747:
2746:
2744:
2742:
2732:
2724:
2718:
2717:
2715:
2713:
2703:
2695:
2689:
2688:
2686:
2684:
2674:
2666:
2660:
2659:
2657:
2629:
2623:
2622:
2620:
2618:
2613:
2604:
2598:
2597:
2579:
2573:
2572:
2557:
2548:
2545:
2539:
2538:
2536:
2534:
2519:
2513:
2512:
2510:
2508:
2499:. Archived from
2492:
2486:
2485:
2468:(5): 1083–1091.
2456:
2450:
2449:
2447:
2445:
2439:
2433:. Archived from
2432:
2420:
2414:
2413:
2392:
2386:
2385:
2379:
2374:
2372:
2364:
2360:
2354:
2353:
2331:
2325:
2324:
2288:
2282:
2281:
2279:
2277:
2271:
2265:. Archived from
2264:
2252:
2246:
2245:
2243:
2241:
2232:. Archived from
2225:
2219:
2218:
2216:
2214:
2203:
2191:
2185:
2184:
2182:
2180:
2166:
2160:
2159:
2157:
2155:
2144:
2132:
2126:
2125:
2115:
2083:
2077:
2076:
2066:
2034:
2028:
2027:
2025:
2023:
2012:
2006:
2005:
2003:
2001:
1992:. Archived from
1985:
1979:
1978:
1950:
1944:
1943:
1941:
1939:
1933:
1927:. Archived from
1926:
1914:
1908:
1907:
1897:
1865:
1859:
1858:
1856:
1854:
1845:. Archived from
1835:
1829:
1828:
1818:
1786:
1780:
1779:
1769:
1752:(8): 1214–1219.
1737:
1731:
1730:
1721:(3): S102–S103.
1710:
1704:
1703:
1701:
1699:
1690:. Archived from
1686:Groupe Novasep.
1683:
1677:
1676:
1674:
1672:
1648:
1642:
1641:
1639:
1637:
1624:
1600:
1594:
1593:
1572:(Supplement 4).
1560:
1554:
1553:
1543:
1519:
1513:
1512:
1484:
1478:
1477:
1471:
1467:
1465:
1457:
1447:
1423:
1417:
1416:
1414:
1412:
1403:. Archived from
1380:
1374:
1373:
1348:
1342:
1341:
1309:
1303:
1302:
1300:
1298:
1283:
1277:
1276:
1274:
1272:
1263:. Archived from
1253:
1244:
1243:
1241:
1239:
1234:on 12 March 2008
1230:. Archived from
1223:
1217:
1216:
1214:
1212:
1203:. Archived from
1196:
1190:
1189:
1187:
1185:
1174:
1168:
1167:
1165:
1163:
1154:. Archived from
1147:
1141:
1140:
1138:
1136:
1125:
1119:
1109:
1100:
1099:
1061:
1055:
1040:
1034:
1010:
1004:
1003:
992:
981:
966:
960:
959:
952:
946:
941:
939:
931:
929:
927:
910:(4th ed.).
904:
898:
897:
891:
889:
884:. 27 August 2013
874:
868:
867:
862:
860:
846:
840:
839:
833:
831:
826:on 6 August 2018
825:
819:. Archived from
814:
805:
799:
792:
304:Cross-validation
3767:
3766:
3762:
3761:
3760:
3758:
3757:
3756:
3737:Product testing
3722:
3721:
3720:
3715:
3702:
3693:Risk management
3651:
3592:Harold Chestnut
3587:Kathleen Carley
3555:
3531:System dynamics
3506:Decision-making
3494:
3470:Fault tolerance
3453:
3412:
3341:
3336:
3294:
3284:
3271:
3268:
3266:Further reading
3263:
3262:
3252:
3250:
3249:on 29 June 2011
3240:
3239:
3235:
3225:
3223:
3210:
3209:
3205:
3195:
3193:
3188:
3187:
3183:
3148:
3147:
3143:
3133:
3131:
3130:on 11 July 2011
3121:
3120:
3116:
3106:
3104:
3094:
3093:
3089:
3079:
3077:
3072:
3071:
3067:
3052:
3031:
3030:
3026:
3013:
3012:
3008:
2991:
2984:
2982:
2978:
2971:
2969:"Archived copy"
2967:
2966:
2962:
2945:
2938:
2936:
2932:
2925:
2923:"Archived copy"
2921:
2920:
2916:
2906:
2904:
2900:
2893:
2889:
2888:
2884:
2874:
2872:
2862:
2861:
2857:
2847:
2845:
2840:
2839:
2835:
2825:
2823:
2814:
2813:
2809:
2799:
2797:
2796:on 20 July 2009
2784:
2783:
2779:
2769:
2767:
2759:
2755:
2754:
2750:
2740:
2738:
2730:
2726:
2725:
2721:
2711:
2709:
2701:
2697:
2696:
2692:
2682:
2680:
2672:
2668:
2667:
2663:
2655:10.1002/qaj.399
2631:
2630:
2626:
2616:
2614:
2611:
2606:
2605:
2601:
2594:
2581:
2580:
2576:
2571:on 6 June 2009.
2559:
2558:
2551:
2546:
2542:
2532:
2530:
2521:
2520:
2516:
2506:
2504:
2503:on 9 April 2008
2494:
2493:
2489:
2458:
2457:
2453:
2443:
2441:
2437:
2430:
2422:
2421:
2417:
2394:
2393:
2389:
2375:
2365:
2362:
2361:
2357:
2350:
2342:. p. 418.
2333:
2332:
2328:
2290:
2289:
2285:
2275:
2273:
2269:
2262:
2254:
2253:
2249:
2239:
2237:
2228:
2226:
2222:
2212:
2210:
2201:
2193:
2192:
2188:
2178:
2176:
2168:
2167:
2163:
2153:
2151:
2142:
2134:
2133:
2129:
2085:
2084:
2080:
2036:
2035:
2031:
2021:
2019:
2014:
2013:
2009:
1999:
1997:
1987:
1986:
1982:
1952:
1951:
1947:
1937:
1935:
1931:
1924:
1916:
1915:
1911:
1867:
1866:
1862:
1852:
1850:
1837:
1836:
1832:
1801:(7379): 25–28.
1788:
1787:
1783:
1739:
1738:
1734:
1712:
1711:
1707:
1697:
1695:
1685:
1684:
1680:
1670:
1668:
1650:
1649:
1645:
1635:
1633:
1602:
1601:
1597:
1562:
1561:
1557:
1521:
1520:
1516:
1486:
1485:
1481:
1468:
1458:
1425:
1424:
1420:
1410:
1408:
1382:
1381:
1377:
1350:
1349:
1345:
1311:
1310:
1306:
1296:
1294:
1285:
1284:
1280:
1270:
1268:
1255:
1254:
1247:
1237:
1235:
1225:
1224:
1220:
1210:
1208:
1198:
1197:
1193:
1183:
1181:
1176:
1175:
1171:
1161:
1159:
1149:
1148:
1144:
1134:
1132:
1127:
1126:
1122:
1110:
1103:
1088:
1063:
1062:
1058:
1041:
1037:
1011:
1007:
994:
993:
984:
967:
963:
953:
942:
932:
925:
923:
906:
905:
901:
887:
885:
876:
875:
871:
858:
856:
848:
847:
843:
829:
827:
823:
812:
807:
806:
802:
793:
789:
784:
779:
740:Positive recall
720:Data validation
700:
551:
539:Medical devices
515:
506:Pharmaceuticals
499:
483:
463:
420:Reproducibility
398:
384:detection limit
321:sample matrices
253:
207:out, requiring
184:
167:
146:
141:
81:the PMBOK guide
72:In reality, as
38:
31:
24:
17:
12:
11:
5:
3765:
3763:
3755:
3754:
3749:
3744:
3739:
3734:
3724:
3723:
3717:
3716:
3714:
3713:
3707:
3704:
3703:
3701:
3700:
3695:
3690:
3685:
3680:
3675:
3670:
3665:
3659:
3657:
3656:Related fields
3653:
3652:
3650:
3649:
3644:
3639:
3634:
3629:
3624:
3622:Radhika Nagpal
3619:
3614:
3612:Derek Hitchins
3609:
3604:
3599:
3594:
3589:
3584:
3579:
3574:
3569:
3567:James S. Albus
3563:
3561:
3557:
3556:
3554:
3553:
3548:
3543:
3538:
3533:
3528:
3523:
3518:
3513:
3508:
3502:
3500:
3496:
3495:
3493:
3492:
3487:
3482:
3477:
3472:
3467:
3461:
3459:
3455:
3454:
3452:
3451:
3446:
3441:
3436:
3431:
3426:
3420:
3418:
3414:
3413:
3411:
3410:
3405:
3400:
3395:
3390:
3385:
3380:
3375:
3370:
3365:
3360:
3355:
3349:
3347:
3343:
3342:
3337:
3335:
3334:
3327:
3320:
3312:
3306:
3305:
3300:
3293:
3292:External links
3290:
3289:
3288:
3282:
3267:
3264:
3261:
3260:
3233:
3203:
3181:
3141:
3114:
3087:
3065:
3050:
3024:
3006:
2960:
2914:
2882:
2871:on 31 May 2012
2855:
2833:
2807:
2777:
2748:
2719:
2690:
2661:
2624:
2599:
2592:
2574:
2549:
2540:
2514:
2487:
2451:
2415:
2387:
2355:
2348:
2326:
2283:
2247:
2220:
2186:
2161:
2127:
2078:
2049:(2): 256–266.
2029:
2007:
1996:on 31 May 2009
1980:
1945:
1909:
1860:
1830:
1781:
1732:
1705:
1678:
1643:
1595:
1555:
1514:
1479:
1418:
1375:
1343:
1304:
1278:
1267:on 6 June 2009
1245:
1218:
1191:
1169:
1142:
1120:
1101:
1086:
1056:
1035:
1005:
996:IEEE 1012-2004
982:
961:
945:|journal=
899:
869:
841:
800:
786:
785:
783:
780:
778:
777:
772:
767:
762:
760:System testing
757:
752:
747:
742:
737:
732:
727:
722:
717:
712:
710:Change control
707:
701:
699:
696:
695:
694:
689:
687:authentication
680:
674:
669:
664:
661:
658:
655:
654:
653:
647:
644:
639:
631:
624:Greenhouse gas
621:
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612:
611:
605:
599:
588:
587:
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573:
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564:
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511:Main article:
508:
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495:Main article:
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341:
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331:
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316:clinical trial
306:
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293:
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268:
261:
252:
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189:do-it-yourself
183:
180:
166:
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159:specifications
145:
142:
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137:
136:
135:
131:
123:
122:
119:
108:Medical device
104:
103:
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55:specifications
15:
13:
10:
9:
6:
4:
3:
2:
3764:
3753:
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3628:
3625:
3623:
3620:
3618:
3615:
3613:
3610:
3608:
3605:
3603:
3602:Barbara Grosz
3600:
3598:
3597:Wolt Fabrycky
3595:
3593:
3590:
3588:
3585:
3583:
3580:
3578:
3575:
3573:
3572:Ruzena Bajcsy
3570:
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3562:
3558:
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3473:
3471:
3468:
3466:
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3462:
3460:
3456:
3450:
3447:
3445:
3444:Design review
3442:
3440:
3437:
3435:
3432:
3430:
3427:
3425:
3422:
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3409:
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3291:
3285:
3279:
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3222:
3218:
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3204:
3192:
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3161:
3157:
3153:
3145:
3142:
3129:
3125:
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3115:
3102:
3098:
3091:
3088:
3075:
3069:
3066:
3061:
3057:
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3028:
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3020:
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3010:
3007:
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2961:
2956:
2950:
2931:
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2337:
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2306:
2302:
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2257:
2251:
2248:
2235:
2231:
2224:
2221:
2209:
2208:
2200:
2196:
2190:
2187:
2175:
2171:
2170:Health Canada
2165:
2162:
2150:
2149:
2141:
2137:
2131:
2128:
2123:
2119:
2114:
2109:
2105:
2101:
2097:
2093:
2089:
2082:
2079:
2074:
2070:
2065:
2060:
2056:
2052:
2048:
2044:
2040:
2033:
2030:
2018:
2011:
2008:
1995:
1991:
1984:
1981:
1976:
1972:
1968:
1964:
1960:
1956:
1949:
1946:
1930:
1923:
1919:
1913:
1910:
1905:
1901:
1896:
1891:
1887:
1883:
1879:
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1864:
1861:
1848:
1844:
1840:
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1808:
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1800:
1796:
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1785:
1782:
1777:
1773:
1768:
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1394:
1390:
1389:Haematologica
1386:
1379:
1376:
1371:
1367:
1363:
1359:
1355:
1347:
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1339:
1335:
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726:
723:
721:
718:
716:
715:Comparability
713:
711:
708:
706:
703:
702:
697:
693:
690:
688:
684:
681:
678:
675:
673:
670:
668:
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656:
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645:
643:
640:
638:
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634:
632:
629:
628:accreditation
625:
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606:
603:
600:
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516:
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489:
488:
487:
480:
475:
470:
467:
466:
465:
464:
461:
457:
453:
448:
440:
438:and its range
437:
436:Curve fitting
434:
432:
429:
426:
423:
421:
418:
416:
415:Repeatability
413:
411:
408:
406:
403:
402:
401:
395:
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385:
381:
379:
375:
374:
372:
371:
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281:
279:
278:
272:
269:
266:
265:
262:
258:
257:
256:
250:
248:
246:
245:ISO/IEC 27001
242:
241:ISO/IEC 15408
238:
233:
230:
226:
222:
218:
214:
210:
209:recalibration
206:
202:
197:
194:
190:
181:
179:
175:
171:
164:
162:
160:
155:
151:
143:
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40:
36:
35:Test validity
29:
22:
3637:Katia Sycara
3521:Optimization
3438:
3273:
3253:15 September
3251:. Retrieved
3247:the original
3236:
3224:. Retrieved
3220:
3216:
3206:
3194:. Retrieved
3184:
3155:
3151:
3144:
3132:. Retrieved
3128:the original
3117:
3105:. Retrieved
3101:the original
3090:
3080:19 September
3078:. Retrieved
3068:
3033:
3027:
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3009:
2983:. Retrieved
2976:the original
2963:
2937:. Retrieved
2930:the original
2917:
2905:. Retrieved
2898:the original
2885:
2873:. Retrieved
2869:the original
2858:
2846:. Retrieved
2836:
2824:. Retrieved
2810:
2798:. Retrieved
2794:the original
2780:
2768:. Retrieved
2751:
2739:. Retrieved
2722:
2710:. Retrieved
2693:
2681:. Retrieved
2664:
2641:
2637:
2627:
2615:. Retrieved
2602:
2583:
2577:
2569:the original
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2531:. Retrieved
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2517:
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2501:the original
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2461:
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2435:the original
2418:
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2390:
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2329:
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2292:
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2276:29 September
2274:. Retrieved
2267:the original
2250:
2240:19 September
2238:. Retrieved
2234:the original
2223:
2211:. Retrieved
2205:
2197:(May 2001).
2189:
2177:. Retrieved
2164:
2152:. Retrieved
2146:
2130:
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2020:. Retrieved
2010:
1998:. Retrieved
1994:the original
1983:
1958:
1954:
1948:
1936:. Retrieved
1929:the original
1912:
1877:
1873:
1863:
1853:30 September
1851:. Retrieved
1847:the original
1833:
1798:
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1749:
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1735:
1718:
1714:
1708:
1698:24 September
1696:. Retrieved
1692:the original
1681:
1669:. Retrieved
1663:
1657:
1646:
1636:24 September
1634:. Retrieved
1612:
1608:
1598:
1569:
1565:
1558:
1531:
1527:
1517:
1492:
1488:
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1411:24 September
1409:. Retrieved
1405:the original
1392:
1388:
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1357:
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1346:
1317:
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1307:
1297:24 September
1295:. Retrieved
1291:the original
1281:
1269:. Retrieved
1265:the original
1236:. Retrieved
1232:the original
1221:
1209:. Retrieved
1205:the original
1194:
1182:. Retrieved
1172:
1160:. Retrieved
1156:the original
1145:
1133:. Retrieved
1123:
1115:
1069:
1059:
1038:
1030:
1026:
1008:
995:
964:
936:cite journal
924:. Retrieved
902:
893:
886:. Retrieved
881:
872:
864:
857:. Retrieved
844:
835:
828:. Retrieved
821:the original
816:
803:
795:
790:
692:Arms control
520:
484:
445:
399:
335:depreciation
289:data systems
254:
234:
198:
193:step-by-step
192:
185:
176:
172:
168:
147:
144:Verification
124:
105:
99:
93:verification
92:
78:
71:
66:
51:requirements
46:
42:
41:
39:
3752:Food safety
3162:: 337–352.
2985:7 September
2907:10 February
2822:. July 1993
1961:(1): 3–10.
1364:: A22–A23.
1324:: 448–454.
1150:Scientech.
1112:Barry Boehm
1031:maintenance
677:Agriculture
618:Health care
576:Engineering
533:laboratory.
201:calibration
110:, the FDA (
3726:Categories
3627:Simon Ramo
2527:dl.acm.org
2378:|url=
672:Accounting
452:robustness
350:monographs
328:population
182:Activities
165:Validation
100:validation
3417:Processes
3346:Subfields
3060:110489981
2340:Wiley-VCH
1226:AppLabs.
1199:AppLabs.
1130:"Welcome"
1096:195769468
1027:operation
895:meanings.
735:ISO 17025
667:Economics
620:: example
596:Buildings
541:The FDA (
79:However,
3711:Category
3458:Concepts
3226:20 March
3196:20 March
3160:Elsevier
3134:20 March
3107:20 March
2995:cite web
2949:cite web
2875:20 March
2848:20 March
2648:: 3–15.
2482:15336355
2369:cite web
2321:14334288
2313:11248467
2172:(2004).
2138:(2009).
2122:18790312
2073:19074299
1920:(2004).
1904:18724601
1825:12511458
1776:11499106
1671:6 August
1631:10625718
1590:58984986
1576:: 361s.
1574:Elsevier
1550:18270659
1509:18371466
1454:18174479
1401:17145595
1362:Elsevier
1338:16631985
1322:Elsevier
1238:26 March
1211:26 March
1184:29 March
1162:18 March
1135:18 March
926:28 March
888:30 April
859:30 April
830:30 April
698:See also
650:Aircraft
568:medicine
491:Software
229:ini file
221:registry
139:Overview
67:IV&V
63:ISO 9000
61:such as
3485:V-Model
3164:Bibcode
2939:14 June
2826:12 July
2800:12 July
2770:12 July
2741:12 July
2712:12 July
2683:12 July
2617:15 June
2533:15 June
2507:29 June
2495:日本药局方.
2444:29 June
2424:Agilent
2213:12 July
2179:12 July
2154:12 July
2113:2602585
2064:2649314
2022:12 July
2000:12 July
1975:8953186
1938:12 July
1895:4952927
1767:1446748
1271:12 July
608:Bridges
354:Ph.Eur.
352:of the
205:stretch
47:V&V
3560:People
3475:System
3280:
3058:
3048:
2679:. 2006
2590:
2480:
2346:
2319:
2311:
2120:
2110:
2071:
2061:
1973:
1902:
1892:
1823:
1816:139501
1813:
1774:
1764:
1629:
1609:Stroke
1588:
1548:
1507:
1452:
1432:Stroke
1399:
1336:
1118:, 1981
1094:
1084:
1029:, and
657:Model:
543:21 CFR
521:et al.
300:range.
112:21 CFR
3499:Tools
3158:(3).
3056:S2CID
2979:(PDF)
2972:(PDF)
2933:(PDF)
2926:(PDF)
2901:(PDF)
2894:(PDF)
2760:(PDF)
2731:(PDF)
2702:(PDF)
2673:(PDF)
2644:(1).
2612:(PDF)
2438:(PDF)
2431:(PDF)
2317:S2CID
2270:(PDF)
2263:(PDF)
2202:(PDF)
2143:(PDF)
1932:(PDF)
1925:(PDF)
1586:S2CID
1360:(5).
1320:(5).
1092:S2CID
824:(PDF)
813:(PDF)
602:Roads
378:assay
154:model
3516:IDEF
3278:ISBN
3255:2008
3228:2008
3198:2008
3136:2008
3109:2008
3082:2011
3046:ISBN
3001:link
2987:2007
2955:link
2941:2008
2909:2011
2877:2008
2850:2008
2828:2009
2802:2009
2772:2009
2743:2009
2714:2009
2685:2009
2619:2008
2588:ISBN
2535:2020
2509:2009
2478:PMID
2446:2009
2382:help
2344:ISBN
2309:PMID
2278:2008
2242:2011
2215:2009
2181:2009
2156:2009
2118:PMID
2069:PMID
2024:2009
2002:2009
1971:PMID
1940:2009
1900:PMID
1855:2008
1821:PMID
1772:PMID
1700:2008
1673:2009
1638:2008
1627:PMID
1546:PMID
1505:PMID
1474:help
1450:PMID
1413:2008
1397:PMID
1334:PMID
1299:2008
1273:2008
1240:2008
1213:2008
1186:2008
1164:2008
1137:2008
1082:ISBN
1052:IEEE
1022:IEEE
1000:IEEE
978:IEEE
956:link
949:help
928:2017
912:IEEE
890:2018
861:2018
832:2018
561:Food
526:GAMP
364:and
217:BIOS
130:use.
53:and
3172:doi
3038:doi
2650:doi
2565:FDA
2470:doi
2406:doi
2301:doi
2108:PMC
2100:doi
2096:372
2059:PMC
2051:doi
1963:doi
1959:686
1890:PMC
1882:doi
1811:PMC
1803:doi
1799:326
1795:BMJ
1762:PMC
1754:doi
1723:doi
1617:doi
1578:doi
1536:doi
1497:doi
1493:115
1440:doi
1366:doi
1326:doi
1074:doi
1048:IEC
1044:ISO
1018:IEC
1014:ISO
974:IEC
970:ISO
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