181:
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.
458:
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.
469:(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
473:, 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:
198:
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
243:
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.
202:(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
457:
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.
452:
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
242:
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
144:
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,
847:
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
206:
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
184:
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
180:
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
197:
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
270:
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,
274:
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
167:
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
140:
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
319:
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
2470:
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".
310:
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
76:. 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 "
3253:
1362:
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".
543:
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
1035:
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,
2645:"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"
529:
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
188:
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.
2406:
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".
222:, 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
2150:
324:
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
102:"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
905:
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
168:
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,
1574:
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".
534:
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
496:
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:
214:, 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
109:"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
3160:
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".
3257:
2768:"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"
2558:
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).
1498:
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".
3108:"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)"
876:
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.
1189:
2270:
1666:
785:
919:"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)"
2146:
1853:
1323:
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".
966:
1964:
Bressolle, Françoise; Brometpetit, M; Audran, M; et al. (1996). "Validation of liquid chromatographic and gas chromatographic methods
Applications to pharmacokinetics".
487:
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.
91:
453:
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.
1724:
Hart, D.; S.W. Smith (2007). "Retrospective
Validation of a Clinical Decision Rule to Safely Rule Out Subarachnoid Hemorrhage in Emergency Department Headache Patients".
95:
2000:
848:
been selected to be different from the term verification. Nevertheless, it is debatable whether the distinction between validation and verification should be continued.
2796:
2571:
1267:
31:
2933:
247:
1932:
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559:
1535:"Improvement in the regulation of the vitamin K antagonist acenocoumarol after a standard initial dose regimen: prospective validation of a prescription model"
2830:
2745:
2687:
2205:
1076:
566:
466:
172:, 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.
553:
122:
3224:"Monitoring the Realization of the Right to Food: Adaptation and Validation of the U.S. Department of Agriculture Food Insecurity Module to Rural Senegal"
1698:
1297:
3011:
2965:
2277:
185:
the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.
991:
std 24765:2010(E), 2010. | verification 5. ...product, service, or system complies with a regulation, requirement, specification, or imposed condition.
1058:
1028:
984:
207:
the activity is to generating and archiving machinery/equipment qualification reports for auditing purposes, if regulatory compliances are mandatory.
1802:"How to evaluate and improve the quality and credibility of an outcomes database: validation and feedback study on the UK Cardiac Surgery Experience"
3383:
3107:
581:: ISO 15198:2004 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer
820:
314:
3313:
3308:
1928:
2438:
3292:
3060:
2602:
2358:
1849:
1096:
536:
344:
out-of-specification] (OOS) investigations, due to the contamination of testing reagents, glasswares, the aging of equipment/devices, or the
3135:"Implications of the Voluntary Michigan Agriculture Environmental Assurance Program (MAEAP) Verification on Livestock Operations, 2000–2004"
2767:
2738:
2709:
760:
507:
38:
1395:
539:
system if one understands the regulatory requirements very well while the most of others follows the conventional process It is a part of
2534:"Optimizing fault injection in FMI co-simulation through sensitivity partitioning | Proceedings of the 2019 Summer Simulation Conference"
1857:
1238:
384:
Concurrent validation – conducted during a routine processing of services, manufacturing or engineering etc. Examples of these could be
2875:
1533:
Van Geest-Daalderop, Johanna H. H.; Hutten, Barbara A.; Péquériaux, Nathalie C. V.; Levi, Marcel; Sturk, Augueste; et al. (2008).
2680:
2209:
556:) has validation and verification requirements for medical devices, as outlined in ASME V&V 40. Also see guidance: and ISO 13485.
65:
3134:
2901:
2619:
3333:
1662:
1271:
1211:
715:
2097:
Tollman, Stephen M; Kahn, Kathleen; Sartorius, Benn; Collinson, Mark A; Clark, Samuel J; Garenne, Michel L; et al. (2008).
368:
210:
Qualification of machinery/equipment is venue dependent, in particular items that are shock sensitive and require balancing or
281:
the change of legislative regulations or standards affects the compliance of the items being released to the public or market.
3500:
3393:
3368:
3202:"Using cross-validation to evaluate ceres-maize yield simulations within a decision support system for precision agriculture"
3025:
2004:
129:
Validation: Ensuring that the device meets the needs and requirements of its intended users and the intended use environment.
2804:
2579:
1275:
1162:
2940:
2099:"Implications of mortality transition for primary health care in rural South Africa: a population-based surveillance study"
2027:
1933:"Guidelines for the Validation of Analytical Methods for Active Constituent, Agricultural and Veterinary Chemical Products"
3459:
3373:
523:
87:
terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably.
2240:
3752:
3721:
3326:
2800:
2774:
2716:
2217:
2158:
1675:
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690:– applications vary from verifying agricultural methodology and production processes to validating agricultural modeling
2979:
637:: ISO 14064 ANSI/ISO: Greenhouse gases – Requirements for greenhouse gas validation and verification bodies for use in
400:
single sample analysis for a chemical assay by a skilled operator with multiplicated online system suitability testings
275:
missing, then the work can not be processed or can only be completed partially. The tasks are considered necessary if:
250:
standard accredited company for a particular division, the process is called certification. Currently, the coverage of
3757:
3742:
3536:
2439:"System suitability testing for Aripiprazole quality control with the Agilent 1120 Compact LC and ZORBAX C-18 columns"
1939:
888:
594:
415:
3201:
2302:
Heyden, Y. Vander; S.W. Smith; et al. (2001). "Guidance for robustness/ruggedness tests in method validation".
2028:"Downstream Processing: A Revalidation Study of Viral Clearance in the Purification of Monoclonal Antibody CB.Hep-1"
1753:"Retrospective Validation of a Surveillance System for Unexplained Illness and Death: New Haven County, Connecticut"
3398:
2876:"A review of current implementation strategies for validation of cleaning processes in the pharmaceutical industry"
372:
3045:
Sixteenth Annual
Battery Conference on Applications and Advances. Proceedings of the Conference (Cat. No.01TH8533)
3043:
Manzo, M.A.; Strawn, D.M.; Hall, S.W. (7 August 2002). "Aerospace nickel-cadmium cell verification-final report".
2184:
3546:
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2266:
125:) defines Validation and Verification as procedures that ensures that the device fulfil their intended purpose.
69:
3747:
3561:
3439:
3434:
3378:
1702:
1301:
1083:. Lecture Notes in Computer Science. Vol. 11615. Cham: Springer International Publishing. pp. 71–90.
356:
3084:
1616:"Identifying Stroke in the Field: Prospective Validation of the Los Angeles Prehospital Stroke Screen (LAPSS)"
864:
3408:
3403:
2710:"Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
2681:"Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"
740:
441:
2507:
3683:
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780:
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60:) are independent procedures that are used together for checking that a product, service, or system meets
3617:
3587:
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3111:
1472:
1439:"Rapid Identification of High-Risk Transient Ischemic Attacks: Prospective Validation of the ABCD Score"
946:
693:
376:
2826:
1615:
831:
17:
3762:
3708:
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3174:
2656:
470:
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accredited organization is limited; the scheme requires a fair amount of efforts to get popularized.
246:
When machinery/equipment qualification is conducted by a standard endorsed third party such as by an
235:
223:
160:
2050:"Evaluating Predictors of Geographic Area Population Size Cut-offs to Manage Re-identification Risk"
3688:
3673:
3642:
3349:
2902:"Discussion Paper on Proposed Draft Guidelines for the Validation of Food Hygiene Control Measures"
2445:
735:
3698:
3693:
3444:
3413:
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2327:
1596:
1396:"Prospective validation of the WHO proposals for the classification of myelodysplastic syndromes"
1242:
1102:
860:
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In a broad way, it usually includes a test of ruggedness among inter-collaborators, or a test of
359:
accredited laboratories, verification/revalidation will even be conducted very often against the
321:
84:
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Kidwell, Chelsea S.; Starkman, S; Eckstein, M; Weems, K; Saver, JL; et al. (2000).
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etc to cater for national needs. These laboratories must have method validation as well.
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and restructuring of the computer which affects especially the pre-settings, such as on
163:. In the development phase, verification procedures involve performing special tests to
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3622:
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Practical examples on traceability, measurement uncertainty and validation in chemistry
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2739:"General Principles of Software validation; Final Guidance for Industry and FDA Staff"
2315:
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1977:
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1801:
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1854:"The White Paper Trust, assurance and safety: The regulation of health professionals"
1592:
1106:
821:"Everything You Thought You Knew about Validation and Verification is Probably Dodgy"
725:
638:
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251:
215:
169:
45:
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159:
Verification is intended to check that a product, service, or system meets a set of
3647:
702:
411:
The most tested attributes in validation tasks may include, but are not limited to
345:
3029:
565:
Manufacturing process and cleaning validation are compulsory and regulated by the
1896:
1455:
1438:
1166:
930:
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1088:
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their confinements by the definition of the term defined by different standards.
61:
2484:
918:
393:
triplicated sample analysis for trace impurities at the marginalized levels of
3637:
3186:
2420:
2244:
1551:
1534:
1511:
1380:
682:
338:
132:
Verification: Ensuring that the device meets its specified design requirements
68:
and that it fulfills its intended purpose. These are critical components of a
3223:
3052:
1077:"Model-Implemented Hybrid Fault Injection for Simulink (Tool Demonstrations)"
2986:
2350:
1817:
745:
677:
360:
2492:
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2132:
2083:
1914:
1835:
1786:
1768:
1641:
1632:
1560:
1519:
1464:
1411:
1348:
2620:"Risk-based equipment qualification: a user/supplier cooperative approach"
2374:"Calibration of dissolution test apparatus (USP apparatus 1 and 2) – SOP".
1985:
3170:
1584:
1372:
1332:
1140:
1075:
Moradi, Mehrdad; Van Acker, Bert; Vanherpen, Ken; Denil, Joachim (2019).
660:
606:
578:
501:
266:
Validation work can generally be categorized by the following functions:
239:
73:
2065:
3495:
2434:
3318:
2347:
Method Validation in Pharmaceutical Analysis: A Guide to best Practice
3485:
618:
2665:
2644:
2185:"Validation Guidelines for Pharmaceutical Dosage Forms (GUIDE-0029)"
388:
164:
2595:
Pharmaceutical Process Validation: An International Third Edition
3526:
2511:
1437:
Sciolla, Rossella; Melis, F; Sinpac, Group; et al. (2008).
1062:
1032:
1010:
988:
922:
612:
571:
227:
3322:
1079:. In Chamberlain, Roger; Taha, Walid; Törngren, Martin (eds.).
2643:
Ocampo, Arlene; Lum, Steven; Chow, Frank; et al. (2007).
2048:
El Eman, Khaled; Brown, A; Abdelmalik, P; et al. (2009).
1065:
std 24765:2010(E), 2010. | validation (especially 1. & 2.)
1054:
1024:
980:
540:
2271:"Guidance Notes on Analytical Method Validation: Methodology"
30:"IV&V" redirects here. For NASA's IV&V Facility, see
2409:
Journal of Liquid Chromatography & Related Technologies
1929:
Australian Pesticides & Veterinary Medicines Authority
1190:"Replacement Parts-Identical, Suitable, or Inappropriate?"
3085:"Improving the efficiency of verification and validation"
786:
Verification and validation of computer simulation models
3309:
Maturity of verification and validation in ICT companies
3254:"Method and system for authenticating appraisal reports"
2210:"Guidance for Industry: Bioanalytical Method Validation"
807:
Quality Management Systems - Process Validation Guidance
278:
prospective validation is missing, inadequate or flawed.
2827:"Guide to inspections validation of cleaning processes"
2797:"Guideline on general principles of process validation"
2572:"GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION"
2147:
United States Department of Health & Human Services
2103:
Journal of the American Medical Informatics Association
2054:
Journal of the American Medical Informatics Association
1268:"Guideline on general principles of process validation"
479:
their intensive labouring demands and time consumption
2854:"Cleaning validation in the pharmaceutical industry"
98:(IEEE), defines them as follows in its 4th edition:
3666:
3570:
3509:
3468:
3427:
3356:
3314:Organisational maturity and functional performance
2566:
2564:
2473:Journal of Pharmaceutical and Biomedical Analysis
2304:Journal of Pharmaceutical and Biomedical Analysis
1053:"Systems and software engineering - Vocabulary,"
1023:"Systems and software engineering - Vocabulary,"
979:"Systems and software engineering - Vocabulary,"
96:Institute of Electrical and Electronics Engineers
889:"Difference between Verification and Validation"
329:transitions. Examples of these changes could be
32:Independent Verification and Validation Facility
27:Methods for checking conformance to requirements
238:, dynamically-linked (shared) libraries, or an
965:CS1 maint: DOI inactive as of September 2024 (
3334:
3222:Randolph, Susan; et al. (October 2007).
1239:"AppLabs attains ISO27001:2005 accreditation"
1188:Torres, Rebecca E.; William A. Hyman (2007).
828:12th INCOSE SA Systems Engineering Conference
560:Validation and verification (medical devices)
291:Some of the examples could be validation of:
8:
3287:. Vol. 1. European Union. p. 217.
2345:Ermer, Joachim; John H. McB. Miller (2005).
294:ancient scriptures that remain controversial
1001:
999:
997:
3341:
3327:
3319:
3133:Vollmer-Sanders, Carrie Lynn; et al.
1449:(2). American Heart Association: 297–302.
1081:Cyber Physical Systems. Model-Based Design
387:duplicated sample analysis for a chemical
2874:Bharadia, Praful D.; Jignyasha A. Bhatt.
2664:
2122:
2073:
1904:
1891:(4). Royal College of Physicians: 371–6.
1825:
1776:
1631:
1550:
1454:
3384:Earth systems engineering and management
1751:Kluger, Michael D.; et al. (2001).
1626:(1). American Heart Association: 71–76.
1262:
1260:
1118:
1116:
809:(GHTF/SG3/N99-10:2004 (Edition 2) page 3
407:Aspects of analytical methods validation
1139:Analytical & Precision Balance Co.
798:
3010:: CS1 maint: archived copy as title (
3003:
2964:: CS1 maint: archived copy as title (
2957:
2388:
2377:
1539:Journal of Thrombosis and Thrombolysis
1480:
1470:
955:
944:
18:Monitoring, reporting and verification
3252:Pruitt, Kirk; Ryan Paul Chamberlain.
2593:Nash, Robert A.; et al. (2003).
1669:Medical Device Quality Systems Manual
7:
1506:(4). Mosby-Year Book Inc.: 609–614.
761:Software verification and validation
508:Software verification and validation
465:within an organization However, the
371:to cater for multinational needs or
39:software verification and validation
3163:Accreditation and Quality Assurance
2597:. Informa Healthcare. p. 860.
2151:"Warning Letter (WL No. 320-08-04)"
1800:Fine, Leon G.; et al. (2003).
2026:del Rosario Alemán, MarĂa (2007).
1881:"Physician revalidation in Europe"
805:Global Harmonization Task Force -
25:
3419:Sociocultural Systems Engineering
1757:American Journal of Public Health
1738:10.1016/j.annemergmed.2007.06.388
1663:U.S. Food and Drug Administration
1394:Germing, U.; et al. (2006).
1341:10.1016/j.annemergmed.2005.11.019
1272:U.S. Food and Drug Administration
1212:"ISV, IHV Certification Programs"
653:Periodic motor vehicle inspection
567:U.S. Food and Drug Administration
467:U.S. Food and Drug Administration
145:and specialist technical reviews.
37:For the software activities, see
1300:. Groupe Novasep. Archived from
716:Certification of voting machines
3283:Majcen, N.; Taylor, P. (2010).
438:– especially for trace elements
3501:Systems development life cycle
3394:Enterprise systems engineering
3369:Biological systems engineering
3228:Economic Rights Working Papers
2618:De Caris, Sandro; et al.
1127:Software Engineering Economics
1:
3460:System of systems engineering
3374:Cognitive systems engineering
2649:The Quality Assurance Journal
2316:10.1016/S0731-7085(00)00529-X
2115:10.1016/S0140-6736(08)61399-9
2001:"Commercial scale production"
1978:10.1016/S0378-4347(96)00088-6
1667:"Ch. 4 PROCESS VALIDATION in
865:"Validation vs. Verification"
641:or other forms of recognition
524:Validation (drug manufacture)
397:, or/and quantification limit
284:reviving of out-of-use items.
44:For validation of tests, see
2831:Food and Drug Administration
2801:Food and Drug Administration
2775:Food and Drug Administration
2746:Food and Drug Administration
2717:Food and Drug Administration
2688:Food and Drug Administration
2218:Food and Drug Administration
2206:Food and Drug Administration
2159:Food and Drug Administration
1897:10.7861/clinmedicine.8-4-371
1726:Annals of Emergency Medicine
1676:Food and Drug Administration
1593:10.1016/0924-9338(96)89148-6
1456:10.1161/STROKEAHA.107.496612
1325:Annals of Emergency Medicine
933:(inactive 12 September 2024)
931:10.1109/IEEESTD.2011.5937011
766:Statistical model validation
513:Food and drug manufacturing
94:, a standard adopted by the
3537:Quality function deployment
3450:Verification and validation
1966:Journal of Chromatography B
1365:Digestive and Liver Disease
1089:10.1007/978-3-030-23703-5_4
595:Engineering validation test
416:Sensitivity and specificity
54:Verification and validation
3779:
3399:Health systems engineering
3200:Thorp, Kelly; et al.
2803:. May 1987. Archived from
2578:. May 1987. Archived from
2485:10.1016/j.jpba.2004.04.005
2310:(5–6). Elsevier: 723–753.
1699:"Retrospective validation"
557:
521:
505:
236:disk drive partition table
43:
36:
29:
3717:
3547:Systems Modeling Language
3187:10.1016/j.rse.2003.12.013
2421:10.1080/10826079808003597
2267:Health Sciences Authority
1999:Peptisyntha S.A. (2009).
1552:10.1007/s11239-008-0203-4
1512:10.1016/j.ahj.2007.11.011
1381:10.1016/j.dld.2007.12.064
348:of associated assets etc.
136:ISO 9001:2015 considers
70:quality management system
3562:Work breakdown structure
3440:Functional specification
3435:Requirements engineering
3379:Configuration management
3053:10.1109/BCAA.2001.905101
2508:"Japanese Pharmacopoeia"
1298:"Prospective validation"
657:Aircraft noise: example
262:Categories of validation
3409:Reliability engineering
3404:Performance engineering
1879:Merkur, Sherry (2008).
1818:10.1136/bmj.326.7379.25
1545:(2). Springer: 207–14.
741:Functional verification
671:(Ni-Cd) cells: example
591:Engineering in general
442:Limit of quantification
297:clinical decision rules
3684:Industrial engineering
3389:Electrical engineering
1769:10.2105/AJPH.91.8.1214
1633:10.1161/01.str.31.1.71
1500:American Heart Journal
1163:"External Calibration"
954:Cite journal requires
893:Software Testing Class
781:Validation master plan
696:– audit reporting and
674:ICT Industry: example
644:Traffic and transport
421:Accuracy and precision
271:products and services.
3618:Arthur David Hall III
3588:Benjamin S. Blanchard
3364:Aerospace engineering
3026:"Service Unavailable"
2657:John Wiley & Sons
694:Real estate appraisal
558:Further information:
504:and computer systems
307:Full-scale validation
161:design specifications
56:(also abbreviated as
3709:Software engineering
3679:Computer engineering
2992:on 27 September 2007
2540:: 1–12. 22 July 2019
2247:on 11 September 2011
1850:Department of Health
819:Ad Sparrius (2016).
793:Notes and references
577:Clinical laboratory
471:analytical chemistry
254:certification by an
224:application software
3753:Systems engineering
3689:Operations research
3674:Control engineering
3643:Joseph Francis Shea
3350:Systems engineering
3179:2004RSEnv..90..337H
3114:on 17 February 2012
3106:Masako, Tsujimoto.
3032:on 13 October 2007.
2777:. 25 September 2006
2283:on 18 February 2012
2241:"Method Validation"
2238:Method Validation;
2066:10.1197/jamia.M2902
1945:on 20 February 2011
1705:on 15 November 2008
1577:European Psychiatry
1418:on 12 November 2010
1304:on 15 November 2008
1218:on 16 February 2008
736:Formal verification
492:Industry references
3758:Drug manufacturing
3743:Quality management
3699:Quality management
3694:Project management
3522:Function modelling
3445:System integration
3414:Safety engineering
3087:. Inderscience.com
3047:. pp. 59–66.
2946:on 12 October 2007
2914:on 11 October 2010
2852:Nassani, Mowafak.
2451:on 5 February 2015
1483:has generic name (
1169:on 29 January 2020
925:. June 2011: 452.
861:James D. McCaffrey
756:Process validation
436:Limit of detection
341:profiles and sizes
322:analytical balance
85:quality management
3730:
3729:
3653:Manuela M. Veloso
3593:Wernher von Braun
3294:978-92-79-12021-3
3062:978-0-7803-6545-2
2748:. 11 January 2002
2719:. 14 January 2005
2604:978-0-8247-0838-2
2415:(16): 2535–2547.
2387:Missing or empty
2360:978-3-527-31255-9
2109:(9642): 893–901.
1885:Clinical Medicine
1860:on 5 October 2012
1406:(12): 1596–1604.
1098:978-3-030-23703-5
1013:, 2004, p. 9
863:(28 April 2006).
776:Usability testing
648:Road safety audit
602:Civil engineering
574:hygiene: example
335:production scales
117:Similarly, for a
16:(Redirected from
3770:
3658:John N. Warfield
3628:Robert E. Machol
3557:Systems modeling
3552:Systems analysis
3491:System lifecycle
3476:Business process
3343:
3336:
3329:
3320:
3298:
3270:
3269:
3267:
3265:
3256:. Archived from
3249:
3243:
3242:
3240:
3238:
3219:
3213:
3212:
3210:
3208:
3197:
3191:
3190:
3157:
3151:
3150:
3148:
3146:
3137:. Archived from
3130:
3124:
3123:
3121:
3119:
3110:. Archived from
3103:
3097:
3096:
3094:
3092:
3081:
3075:
3074:
3040:
3034:
3033:
3028:. Archived from
3022:
3016:
3015:
3009:
3001:
2999:
2997:
2991:
2985:. Archived from
2984:
2976:
2970:
2969:
2963:
2955:
2953:
2951:
2945:
2939:. Archived from
2938:
2930:
2924:
2923:
2921:
2919:
2913:
2907:. Archived from
2906:
2898:
2892:
2891:
2889:
2887:
2878:. Archived from
2871:
2865:
2864:
2862:
2860:
2849:
2843:
2842:
2840:
2838:
2823:
2817:
2816:
2814:
2812:
2793:
2787:
2786:
2784:
2782:
2772:
2764:
2758:
2757:
2755:
2753:
2743:
2735:
2729:
2728:
2726:
2724:
2714:
2706:
2700:
2699:
2697:
2695:
2685:
2677:
2671:
2670:
2668:
2640:
2634:
2633:
2631:
2629:
2624:
2615:
2609:
2608:
2590:
2584:
2583:
2568:
2559:
2556:
2550:
2549:
2547:
2545:
2530:
2524:
2523:
2521:
2519:
2510:. Archived from
2503:
2497:
2496:
2479:(5): 1083–1091.
2467:
2461:
2460:
2458:
2456:
2450:
2444:. Archived from
2443:
2431:
2425:
2424:
2403:
2397:
2396:
2390:
2385:
2383:
2375:
2371:
2365:
2364:
2342:
2336:
2335:
2299:
2293:
2292:
2290:
2288:
2282:
2276:. Archived from
2275:
2263:
2257:
2256:
2254:
2252:
2243:. Archived from
2236:
2230:
2229:
2227:
2225:
2214:
2202:
2196:
2195:
2193:
2191:
2177:
2171:
2170:
2168:
2166:
2155:
2143:
2137:
2136:
2126:
2094:
2088:
2087:
2077:
2045:
2039:
2038:
2036:
2034:
2023:
2017:
2016:
2014:
2012:
2003:. Archived from
1996:
1990:
1989:
1961:
1955:
1954:
1952:
1950:
1944:
1938:. Archived from
1937:
1925:
1919:
1918:
1908:
1876:
1870:
1869:
1867:
1865:
1856:. Archived from
1846:
1840:
1839:
1829:
1797:
1791:
1790:
1780:
1763:(8): 1214–1219.
1748:
1742:
1741:
1732:(3): S102–S103.
1721:
1715:
1714:
1712:
1710:
1701:. Archived from
1697:Groupe Novasep.
1694:
1688:
1687:
1685:
1683:
1659:
1653:
1652:
1650:
1648:
1635:
1611:
1605:
1604:
1583:(Supplement 4).
1571:
1565:
1564:
1554:
1530:
1524:
1523:
1495:
1489:
1488:
1482:
1478:
1476:
1468:
1458:
1434:
1428:
1427:
1425:
1423:
1414:. Archived from
1391:
1385:
1384:
1359:
1353:
1352:
1320:
1314:
1313:
1311:
1309:
1294:
1288:
1287:
1285:
1283:
1274:. Archived from
1264:
1255:
1254:
1252:
1250:
1245:on 12 March 2008
1241:. Archived from
1234:
1228:
1227:
1225:
1223:
1214:. Archived from
1207:
1201:
1200:
1198:
1196:
1185:
1179:
1178:
1176:
1174:
1165:. Archived from
1158:
1152:
1151:
1149:
1147:
1136:
1130:
1120:
1111:
1110:
1072:
1066:
1051:
1045:
1021:
1015:
1014:
1003:
992:
977:
971:
970:
963:
957:
952:
950:
942:
940:
938:
921:(4th ed.).
915:
909:
908:
902:
900:
895:. 27 August 2013
885:
879:
878:
873:
871:
857:
851:
850:
844:
842:
837:on 6 August 2018
836:
830:. Archived from
825:
816:
810:
803:
315:Cross-validation
21:
3778:
3777:
3773:
3772:
3771:
3769:
3768:
3767:
3748:Product testing
3733:
3732:
3731:
3726:
3713:
3704:Risk management
3662:
3603:Harold Chestnut
3598:Kathleen Carley
3566:
3542:System dynamics
3517:Decision-making
3505:
3481:Fault tolerance
3464:
3423:
3352:
3347:
3305:
3295:
3282:
3279:
3277:Further reading
3274:
3273:
3263:
3261:
3260:on 29 June 2011
3251:
3250:
3246:
3236:
3234:
3221:
3220:
3216:
3206:
3204:
3199:
3198:
3194:
3159:
3158:
3154:
3144:
3142:
3141:on 11 July 2011
3132:
3131:
3127:
3117:
3115:
3105:
3104:
3100:
3090:
3088:
3083:
3082:
3078:
3063:
3042:
3041:
3037:
3024:
3023:
3019:
3002:
2995:
2993:
2989:
2982:
2980:"Archived copy"
2978:
2977:
2973:
2956:
2949:
2947:
2943:
2936:
2934:"Archived copy"
2932:
2931:
2927:
2917:
2915:
2911:
2904:
2900:
2899:
2895:
2885:
2883:
2873:
2872:
2868:
2858:
2856:
2851:
2850:
2846:
2836:
2834:
2825:
2824:
2820:
2810:
2808:
2807:on 20 July 2009
2795:
2794:
2790:
2780:
2778:
2770:
2766:
2765:
2761:
2751:
2749:
2741:
2737:
2736:
2732:
2722:
2720:
2712:
2708:
2707:
2703:
2693:
2691:
2683:
2679:
2678:
2674:
2666:10.1002/qaj.399
2642:
2641:
2637:
2627:
2625:
2622:
2617:
2616:
2612:
2605:
2592:
2591:
2587:
2582:on 6 June 2009.
2570:
2569:
2562:
2557:
2553:
2543:
2541:
2532:
2531:
2527:
2517:
2515:
2514:on 9 April 2008
2505:
2504:
2500:
2469:
2468:
2464:
2454:
2452:
2448:
2441:
2433:
2432:
2428:
2405:
2404:
2400:
2386:
2376:
2373:
2372:
2368:
2361:
2353:. p. 418.
2344:
2343:
2339:
2301:
2300:
2296:
2286:
2284:
2280:
2273:
2265:
2264:
2260:
2250:
2248:
2239:
2237:
2233:
2223:
2221:
2212:
2204:
2203:
2199:
2189:
2187:
2179:
2178:
2174:
2164:
2162:
2153:
2145:
2144:
2140:
2096:
2095:
2091:
2047:
2046:
2042:
2032:
2030:
2025:
2024:
2020:
2010:
2008:
1998:
1997:
1993:
1963:
1962:
1958:
1948:
1946:
1942:
1935:
1927:
1926:
1922:
1878:
1877:
1873:
1863:
1861:
1848:
1847:
1843:
1812:(7379): 25–28.
1799:
1798:
1794:
1750:
1749:
1745:
1723:
1722:
1718:
1708:
1706:
1696:
1695:
1691:
1681:
1679:
1661:
1660:
1656:
1646:
1644:
1613:
1612:
1608:
1573:
1572:
1568:
1532:
1531:
1527:
1497:
1496:
1492:
1479:
1469:
1436:
1435:
1431:
1421:
1419:
1393:
1392:
1388:
1361:
1360:
1356:
1322:
1321:
1317:
1307:
1305:
1296:
1295:
1291:
1281:
1279:
1266:
1265:
1258:
1248:
1246:
1236:
1235:
1231:
1221:
1219:
1209:
1208:
1204:
1194:
1192:
1187:
1186:
1182:
1172:
1170:
1160:
1159:
1155:
1145:
1143:
1138:
1137:
1133:
1121:
1114:
1099:
1074:
1073:
1069:
1052:
1048:
1022:
1018:
1005:
1004:
995:
978:
974:
964:
953:
943:
936:
934:
917:
916:
912:
898:
896:
887:
886:
882:
869:
867:
859:
858:
854:
840:
838:
834:
823:
818:
817:
813:
804:
800:
795:
790:
751:Positive recall
731:Data validation
711:
562:
550:Medical devices
526:
517:Pharmaceuticals
510:
494:
474:
431:Reproducibility
409:
395:detection limit
332:sample matrices
264:
218:out, requiring
195:
178:
157:
152:
92:the PMBOK guide
83:In reality, as
49:
42:
35:
28:
23:
22:
15:
12:
11:
5:
3776:
3774:
3766:
3765:
3760:
3755:
3750:
3745:
3735:
3734:
3728:
3727:
3725:
3724:
3718:
3715:
3714:
3712:
3711:
3706:
3701:
3696:
3691:
3686:
3681:
3676:
3670:
3668:
3667:Related fields
3664:
3663:
3661:
3660:
3655:
3650:
3645:
3640:
3635:
3633:Radhika Nagpal
3630:
3625:
3623:Derek Hitchins
3620:
3615:
3610:
3605:
3600:
3595:
3590:
3585:
3580:
3578:James S. Albus
3574:
3572:
3568:
3567:
3565:
3564:
3559:
3554:
3549:
3544:
3539:
3534:
3529:
3524:
3519:
3513:
3511:
3507:
3506:
3504:
3503:
3498:
3493:
3488:
3483:
3478:
3472:
3470:
3466:
3465:
3463:
3462:
3457:
3452:
3447:
3442:
3437:
3431:
3429:
3425:
3424:
3422:
3421:
3416:
3411:
3406:
3401:
3396:
3391:
3386:
3381:
3376:
3371:
3366:
3360:
3358:
3354:
3353:
3348:
3346:
3345:
3338:
3331:
3323:
3317:
3316:
3311:
3304:
3303:External links
3301:
3300:
3299:
3293:
3278:
3275:
3272:
3271:
3244:
3214:
3192:
3152:
3125:
3098:
3076:
3061:
3035:
3017:
2971:
2925:
2893:
2882:on 31 May 2012
2866:
2844:
2818:
2788:
2759:
2730:
2701:
2672:
2635:
2610:
2603:
2585:
2560:
2551:
2525:
2498:
2462:
2426:
2398:
2366:
2359:
2337:
2294:
2258:
2231:
2197:
2172:
2138:
2089:
2060:(2): 256–266.
2040:
2018:
2007:on 31 May 2009
1991:
1956:
1920:
1871:
1841:
1792:
1743:
1716:
1689:
1654:
1606:
1566:
1525:
1490:
1429:
1386:
1354:
1315:
1289:
1278:on 6 June 2009
1256:
1229:
1202:
1180:
1153:
1131:
1112:
1097:
1067:
1046:
1016:
1007:IEEE 1012-2004
993:
972:
956:|journal=
910:
880:
852:
811:
797:
796:
794:
791:
789:
788:
783:
778:
773:
771:System testing
768:
763:
758:
753:
748:
743:
738:
733:
728:
723:
721:Change control
718:
712:
710:
707:
706:
705:
700:
698:authentication
691:
685:
680:
675:
672:
669:
666:
665:
664:
658:
655:
650:
642:
635:Greenhouse gas
632:
626:
625:
624:
623:
622:
616:
610:
599:
598:
597:
584:
583:
582:
575:
569:
563:
547:
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522:Main article:
519:
511:
506:Main article:
493:
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381:
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352:
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349:
342:
336:
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327:clinical trial
317:
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302:
301:
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288:
287:
286:
285:
282:
279:
272:
263:
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200:do-it-yourself
194:
191:
177:
174:
170:specifications
156:
153:
151:
148:
147:
146:
142:
134:
133:
130:
119:Medical device
115:
114:
107:
66:specifications
26:
24:
14:
13:
10:
9:
6:
4:
3:
2:
3775:
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3641:
3639:
3636:
3634:
3631:
3629:
3626:
3624:
3621:
3619:
3616:
3614:
3613:Barbara Grosz
3611:
3609:
3608:Wolt Fabrycky
3606:
3604:
3601:
3599:
3596:
3594:
3591:
3589:
3586:
3584:
3583:Ruzena Bajcsy
3581:
3579:
3576:
3575:
3573:
3569:
3563:
3560:
3558:
3555:
3553:
3550:
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3499:
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3487:
3484:
3482:
3479:
3477:
3474:
3473:
3471:
3467:
3461:
3458:
3456:
3455:Design review
3453:
3451:
3448:
3446:
3443:
3441:
3438:
3436:
3433:
3432:
3430:
3426:
3420:
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3310:
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3306:
3302:
3296:
3290:
3286:
3281:
3280:
3276:
3259:
3255:
3248:
3245:
3233:
3229:
3225:
3218:
3215:
3203:
3196:
3193:
3188:
3184:
3180:
3176:
3172:
3168:
3164:
3156:
3153:
3140:
3136:
3129:
3126:
3113:
3109:
3102:
3099:
3086:
3080:
3077:
3072:
3068:
3064:
3058:
3054:
3050:
3046:
3039:
3036:
3031:
3027:
3021:
3018:
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3007:
2988:
2981:
2975:
2972:
2967:
2961:
2942:
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2929:
2926:
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2806:
2802:
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2792:
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2646:
2639:
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2367:
2362:
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2341:
2338:
2333:
2329:
2325:
2321:
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2309:
2305:
2298:
2295:
2279:
2272:
2268:
2262:
2259:
2246:
2242:
2235:
2232:
2220:
2219:
2211:
2207:
2201:
2198:
2186:
2182:
2181:Health Canada
2176:
2173:
2161:
2160:
2152:
2148:
2142:
2139:
2134:
2130:
2125:
2120:
2116:
2112:
2108:
2104:
2100:
2093:
2090:
2085:
2081:
2076:
2071:
2067:
2063:
2059:
2055:
2051:
2044:
2041:
2029:
2022:
2019:
2006:
2002:
1995:
1992:
1987:
1983:
1979:
1975:
1971:
1967:
1960:
1957:
1941:
1934:
1930:
1924:
1921:
1916:
1912:
1907:
1902:
1898:
1894:
1890:
1886:
1882:
1875:
1872:
1859:
1855:
1851:
1845:
1842:
1837:
1833:
1828:
1823:
1819:
1815:
1811:
1807:
1803:
1796:
1793:
1788:
1784:
1779:
1774:
1770:
1766:
1762:
1758:
1754:
1747:
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1731:
1727:
1720:
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1452:
1448:
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1409:
1405:
1401:
1400:Haematologica
1397:
1390:
1387:
1382:
1378:
1374:
1370:
1366:
1358:
1355:
1350:
1346:
1342:
1338:
1334:
1330:
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1299:
1293:
1290:
1277:
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1240:
1233:
1230:
1217:
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1206:
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1191:
1184:
1181:
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1164:
1157:
1154:
1142:
1135:
1132:
1128:
1124:
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1117:
1113:
1108:
1104:
1100:
1094:
1090:
1086:
1082:
1078:
1071:
1068:
1064:
1060:
1056:
1050:
1047:
1043:
1039:
1034:
1030:
1026:
1020:
1017:
1012:
1008:
1002:
1000:
998:
994:
990:
986:
982:
976:
973:
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932:
928:
924:
920:
914:
911:
907:
894:
890:
884:
881:
877:
866:
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833:
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822:
815:
812:
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779:
777:
774:
772:
769:
767:
764:
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759:
757:
754:
752:
749:
747:
744:
742:
739:
737:
734:
732:
729:
727:
726:Comparability
724:
722:
719:
717:
714:
713:
708:
704:
701:
699:
695:
692:
689:
686:
684:
681:
679:
676:
673:
670:
667:
662:
659:
656:
654:
651:
649:
646:
645:
643:
640:
639:accreditation
636:
633:
630:
627:
620:
617:
614:
611:
608:
605:
604:
603:
600:
596:
593:
592:
590:
589:
588:
585:
580:
576:
573:
570:
568:
564:
561:
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551:
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538:
533:
528:
527:
525:
520:
518:
515:
514:
512:
509:
503:
500:
499:
498:
491:
486:
481:
478:
477:
476:
475:
472:
468:
464:
459:
451:
449:and its range
448:
447:Curve fitting
445:
443:
440:
437:
434:
432:
429:
427:
426:Repeatability
424:
422:
419:
417:
414:
413:
412:
406:
399:
396:
392:
390:
386:
385:
383:
382:
378:
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353:
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343:
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323:
318:
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309:
306:
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299:
296:
293:
292:
290:
289:
283:
280:
277:
276:
273:
269:
268:
267:
261:
259:
257:
256:ISO/IEC 27001
253:
252:ISO/IEC 15408
249:
244:
241:
237:
233:
229:
225:
221:
220:recalibration
217:
213:
208:
205:
201:
192:
190:
186:
182:
175:
173:
171:
166:
162:
154:
149:
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126:
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112:
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100:
99:
97:
93:
88:
86:
81:
79:
75:
71:
67:
63:
59:
55:
51:
47:
46:Test validity
40:
33:
19:
3648:Katia Sycara
3532:Optimization
3449:
3284:
3264:15 September
3262:. Retrieved
3258:the original
3247:
3235:. Retrieved
3231:
3227:
3217:
3205:. Retrieved
3195:
3166:
3162:
3155:
3143:. Retrieved
3139:the original
3128:
3116:. Retrieved
3112:the original
3101:
3091:19 September
3089:. Retrieved
3079:
3044:
3038:
3030:the original
3020:
2994:. Retrieved
2987:the original
2974:
2948:. Retrieved
2941:the original
2928:
2916:. Retrieved
2909:the original
2896:
2884:. Retrieved
2880:the original
2869:
2857:. Retrieved
2847:
2835:. Retrieved
2821:
2809:. Retrieved
2805:the original
2791:
2779:. Retrieved
2762:
2750:. Retrieved
2733:
2721:. Retrieved
2704:
2692:. Retrieved
2675:
2652:
2648:
2638:
2626:. Retrieved
2613:
2594:
2588:
2580:the original
2575:
2554:
2542:. Retrieved
2537:
2528:
2516:. Retrieved
2512:the original
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2476:
2472:
2465:
2453:. Retrieved
2446:the original
2429:
2412:
2408:
2401:
2369:
2346:
2340:
2307:
2303:
2297:
2287:29 September
2285:. Retrieved
2278:the original
2261:
2251:19 September
2249:. Retrieved
2245:the original
2234:
2222:. Retrieved
2216:
2208:(May 2001).
2200:
2188:. Retrieved
2175:
2163:. Retrieved
2157:
2141:
2106:
2102:
2092:
2057:
2053:
2043:
2031:. Retrieved
2021:
2009:. Retrieved
2005:the original
1994:
1969:
1965:
1959:
1947:. Retrieved
1940:the original
1923:
1888:
1884:
1874:
1864:30 September
1862:. Retrieved
1858:the original
1844:
1809:
1805:
1795:
1760:
1756:
1746:
1729:
1725:
1719:
1709:24 September
1707:. Retrieved
1703:the original
1692:
1680:. Retrieved
1674:
1668:
1657:
1647:24 September
1645:. Retrieved
1623:
1619:
1609:
1580:
1576:
1569:
1542:
1538:
1528:
1503:
1499:
1493:
1473:cite journal
1446:
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1422:24 September
1420:. Retrieved
1416:the original
1403:
1399:
1389:
1368:
1364:
1357:
1328:
1324:
1318:
1308:24 September
1306:. Retrieved
1302:the original
1292:
1280:. Retrieved
1276:the original
1247:. Retrieved
1243:the original
1232:
1220:. Retrieved
1216:the original
1205:
1193:. Retrieved
1183:
1171:. Retrieved
1167:the original
1156:
1144:. Retrieved
1134:
1126:
1080:
1070:
1049:
1041:
1037:
1019:
1006:
975:
947:cite journal
935:. Retrieved
913:
904:
897:. Retrieved
892:
883:
875:
868:. Retrieved
855:
846:
839:. Retrieved
832:the original
827:
814:
806:
801:
703:Arms control
531:
495:
456:
410:
346:depreciation
300:data systems
265:
245:
209:
204:step-by-step
203:
196:
187:
183:
179:
158:
155:Verification
135:
116:
110:
104:verification
103:
89:
82:
77:
62:requirements
57:
53:
52:
50:
3763:Food safety
3173:: 337–352.
2996:7 September
2918:10 February
2833:. July 1993
1972:(1): 3–10.
1375:: A22–A23.
1335:: 448–454.
1161:Scientech.
1123:Barry Boehm
1042:maintenance
688:Agriculture
629:Health care
587:Engineering
544:laboratory.
212:calibration
121:, the FDA (
3737:Categories
3638:Simon Ramo
2538:dl.acm.org
2389:|url=
683:Accounting
463:robustness
361:monographs
339:population
193:Activities
176:Validation
111:validation
3428:Processes
3357:Subfields
3071:110489981
2351:Wiley-VCH
1237:AppLabs.
1210:AppLabs.
1141:"Welcome"
1107:195769468
1038:operation
906:meanings.
746:ISO 17025
678:Economics
631:: example
607:Buildings
552:The FDA (
90:However,
3722:Category
3469:Concepts
3237:20 March
3207:20 March
3171:Elsevier
3145:20 March
3118:20 March
3006:cite web
2960:cite web
2886:20 March
2859:20 March
2659:: 3–15.
2493:15336355
2380:cite web
2332:14334288
2324:11248467
2183:(2004).
2149:(2009).
2133:18790312
2084:19074299
1931:(2004).
1915:18724601
1836:12511458
1787:11499106
1682:6 August
1642:10625718
1601:58984986
1587:: 361s.
1585:Elsevier
1561:18270659
1520:18371466
1465:18174479
1412:17145595
1373:Elsevier
1349:16631985
1333:Elsevier
1249:26 March
1222:26 March
1195:29 March
1173:18 March
1146:18 March
937:28 March
899:30 April
870:30 April
841:30 April
709:See also
661:Aircraft
579:medicine
502:Software
240:ini file
232:registry
150:Overview
78:IV&V
74:ISO 9000
72:such as
3496:V-Model
3175:Bibcode
2950:14 June
2837:12 July
2811:12 July
2781:12 July
2752:12 July
2723:12 July
2694:12 July
2628:15 June
2544:15 June
2518:29 June
2506:日本药局方.
2455:29 June
2435:Agilent
2224:12 July
2190:12 July
2165:12 July
2124:2602585
2075:2649314
2033:12 July
2011:12 July
1986:8953186
1949:12 July
1906:4952927
1778:1446748
1282:12 July
619:Bridges
365:Ph.Eur.
363:of the
216:stretch
58:V&V
3571:People
3486:System
3291:
3069:
3059:
2690:. 2006
2601:
2491:
2357:
2330:
2322:
2131:
2121:
2082:
2072:
1984:
1913:
1903:
1834:
1827:139501
1824:
1785:
1775:
1640:
1620:Stroke
1599:
1559:
1518:
1463:
1443:Stroke
1410:
1347:
1129:, 1981
1105:
1095:
1040:, and
668:Model:
554:21 CFR
532:et al.
311:range.
123:21 CFR
3510:Tools
3169:(3).
3067:S2CID
2990:(PDF)
2983:(PDF)
2944:(PDF)
2937:(PDF)
2912:(PDF)
2905:(PDF)
2771:(PDF)
2742:(PDF)
2713:(PDF)
2684:(PDF)
2655:(1).
2623:(PDF)
2449:(PDF)
2442:(PDF)
2328:S2CID
2281:(PDF)
2274:(PDF)
2213:(PDF)
2154:(PDF)
1943:(PDF)
1936:(PDF)
1597:S2CID
1371:(5).
1331:(5).
1103:S2CID
835:(PDF)
824:(PDF)
613:Roads
389:assay
165:model
3527:IDEF
3289:ISBN
3266:2008
3239:2008
3209:2008
3147:2008
3120:2008
3093:2011
3057:ISBN
3012:link
2998:2007
2966:link
2952:2008
2920:2011
2888:2008
2861:2008
2839:2009
2813:2009
2783:2009
2754:2009
2725:2009
2696:2009
2630:2008
2599:ISBN
2546:2020
2520:2009
2489:PMID
2457:2009
2393:help
2355:ISBN
2320:PMID
2289:2008
2253:2011
2226:2009
2192:2009
2167:2009
2129:PMID
2080:PMID
2035:2009
2013:2009
1982:PMID
1951:2009
1911:PMID
1866:2008
1832:PMID
1783:PMID
1711:2008
1684:2009
1649:2008
1638:PMID
1557:PMID
1516:PMID
1485:help
1461:PMID
1424:2008
1408:PMID
1345:PMID
1310:2008
1284:2008
1251:2008
1224:2008
1197:2008
1175:2008
1148:2008
1093:ISBN
1063:IEEE
1033:IEEE
1011:IEEE
989:IEEE
967:link
960:help
939:2017
923:IEEE
901:2018
872:2018
843:2018
572:Food
537:GAMP
375:and
228:BIOS
141:use.
64:and
3183:doi
3049:doi
2661:doi
2576:FDA
2481:doi
2417:doi
2312:doi
2119:PMC
2111:doi
2107:372
2070:PMC
2062:doi
1974:doi
1970:686
1901:PMC
1893:doi
1822:PMC
1814:doi
1810:326
1806:BMJ
1773:PMC
1765:doi
1734:doi
1628:doi
1589:doi
1547:doi
1508:doi
1504:115
1451:doi
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