Verification and validation

IV&V redirects here. For NASAs IV&V Facility, seeIndependent Verification and Validation Facility.

Verification and validation are independent proceduresthat are used together for checking that a product, ser-vice, or system meets requirements and specificationsand that it fulfills its intended purpose.[1] These are criti-cal components of a quality management system such asISO 9000. The words verification and validation aresometimes preceded with independent, indicating thatthe verification and validation is to be performed by a dis-interested third party. Independent verification and val-idation can be abbreviated as "IV&V".In practice, the usage of these terms varies. Sometimesthey are even used interchangeably.The PMBOK guide, a standard adopted by IEEE, definesthem as follows in its 4th edition:[2]

Validation. The assurance that a product, service,or systemmeets the needs of the customer and otheridentified stakeholders. It often involves acceptanceand suitability with external customers. Contrastwith verification.

Verification. The evaluation of whether or not aproduct, service, or system complies with a regula-tion, requirement, specification, or imposed condi-tion. It is often an internal process. Contrast withvalidation.

1 Overview

Verification is intended to check that a product, service,or system (or portion thereof, or set thereof) meets a setof design specifications. In the development phase, ver-ification procedures involve performing special tests tomodel or simulate a portion, or the entirety, of a product,service or system, then performing a review or analysisof the modeling results. In the post-development phase,verification procedures involve regularly repeating testsdevised specifically to ensure that the product, service, orsystem continues to meet the initial design requirements,specifications, and regulations as time progresses. It is aprocess that is used to evaluate whether a product, ser-vice, or system complies with regulations, specifications,or conditions imposed at the start of a development phase.Verification can be in development, scale-up, or produc-tion. This is often an internal process.

Validation is intended to ensure a product, service, or sys-tem (or portion thereof, or set thereof) result in a prod-uct, service, or system (or portion thereof, or set thereof)that meets the operational needs of the user. For a newdevelopment flow or verification flow, validation proce-dures may involve modeling either flow and using simu-lations to predict faults or gaps that might lead to invalidor incomplete verification or development of a product,service, or system (or portion thereof, or set thereof). Aset of validation requirements (as defined by the user),specifications, and regulations may then be used as a basisfor qualifying a development flow or verification flow fora product, service, or system (or portion thereof, or setthereof). Additional validation procedures also includethose that are designed specifically to ensure that modifi-cations made to an existing qualified development flow orverification flow will have the effect of producing a prod-uct, service, or system (or portion thereof, or set thereof)that meets the initial design requirements, specifications,and regulations; these validations help to keep the flowqualified. It is a process of establishing evidence that pro-vides a high degree of assurance that a product, service,or system accomplishes its intended requirements. Thisoften involves acceptance of fitness for purpose with endusers and other product stakeholders. This is often anexternal process.It is sometimes said that validation can be expressed bythe query Are you building the right thing?"[3] and ver-ification by Are you building it right?".[3] Building theright thing refers back to the users needs, while build-ing it right checks that the specifications are correctlyimplemented by the system. In some contexts, it is re-quired to have written requirements for both as well asformal procedures or protocols for determining compli-ance.It is entirely possible that a product passes when verifiedbut fails when validated. This can happen when, say, aproduct is built as per the specifications but the specifica-tions themselves fail to address the users needs.

2 Activities

Verification of machinery and equipment usually con-sists of design qualification (DQ), installation qualifi-cation (IQ), operational qualification (OQ), and perfor-mance qualification (PQ). DQ may be performed by avendor or by the user, by confirming through review andtesting that the equipment meets the written acquisition

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2 3 CATEGORIES OF VALIDATION

specification. If the relevant document or manuals of ma-chinery/equipment are provided by vendors, the later 3Qneeds to be thoroughly performed by the users who workin an industrial regulatory environment. Otherwise, theprocess of IQ, OQ and PQ is the task of validation. Thetypical example of such a case could be the loss or ab-sence of vendors documentation for legacy equipmentor do-it-yourself (DIY) assemblies (e.g., cars, computersetc.) and, therefore, users should endeavour to acquireDQ document beforehand. Each template of DQ, IQ, OQand PQ usually can be found on the internet respectively,whereas the DIY qualifications of machinery/equipmentcan be assisted either by the vendors training course ma-terials and tutorials, or by the published guidance books,such as step-by-step series if the acquisition of machin-ery/equipment is not bundled with on- site qualificationservices. This kind of the DIY approach is also applicableto the qualifications of software, computer operating sys-tems and a manufacturing process. The most importantand critical task as the last step of the activity is to gen-erating and archiving machinery/equipment qualificationreports for auditing purposes, if regulatory compliancesare mandatory.Qualification of machinery/equipment is venue depen-dent, in particular items that are shock sensitive and re-quire balancing or calibration, and re-qualification needsto be conducted once the objects are relocated. Thefull scales of some equipment qualifications are eventime dependent as consumables are used up (i.e. fil-ters) or springs stretch out, requiring recalibration, andhence re-certification is necessary when a specified duetime lapse.[4][5] Re-qualification of machinery/equipmentshould also be conducted when replacement of parts,or coupling with another device, or installing a newapplication software and restructuring of the computerwhich affects especially the pre-settings, such as onBIOS, registry, disk drive partition table, dynamically-linked (shared) libraries, or an ini file etc., have beennecessary. In such a situation, the specifications of theparts/devices/software and restructuring proposals shouldbe appended to the qualification document whether theparts/devices/software are genuine or not. Torres andHy-man have discussed the suitability of non genuine partsfor clinical use and provided guidelines for equipmentusers to select appropriate substitutes which are capa-ble to avoid adverse effects.[6] In the case when genuineparts/devices/software are demanded by some of regula-tory requirements, then re-qualification does not need tobe conducted on the non genuine assemblies. Instead, theasset has to be recycled for non regulatory purposes.When machinery/equipment qualification is conductedby a standard endorsed third party such as by an ISO stan-dard accredited company for a particular division, theprocess is called certification.[7][8] Currently, the cover-age of ISO/IEC 15408 certification by an ISO/IEC 27001accredited organization is limited, the scheme requires afair amount of efforts to get popularized.

3 Categories of validation

Validation work can generally be categorized by the fol-lowing functions:

Prospective validation the missions conductedbefore new items are released to make surethe characteristics of the interests which arefunctioning properly and which meet safetystandards.[9][10] Some examples could be legislativerules, guidelines or proposals,[11][12][13] methods,[14]theories/hypothesis/models[15][16] products andservices[17][18]

Retrospective validation a process for items thatare already in use and distribution or production.The validation is performed against the writtenspecifications or predetermined expectations, basedupon their historical data/evidences that are docu-mented/recorded. If any critical data is missing,then the work can not be processed or can only becompleted partially.[9][19][20] The tasks are consid-ered necessary if:

prospective validation is missing, inadequateor flawed.

the change of legislative regulations or stan-dards affects the compliance of the items be-ing released to the public or market.

reviving of out-of-use items.

Some of the examples could be validation of:

ancient scriptures that remaincontroversial[21][22]

clinical decision rules[23] data systems[24][25]

Full-scale validation

Partial validation often used for research and pilotstudies if time is constrained. The most importantand significant effects are tested. From an analyticalchemistry perspective, those effects are selectivity,accuracy, repeatability, linearity and its range.

Cross-validation

Re-validation/Locational or Periodical validation carried out, for the item of interest that is dis-missed, repaired, integrated/coupled, relocated, orafter a specified time lapse. Examples of thiscategory could be relicencing/renewing drivers li-cense, recertifying an analytical balance that hasbeen expired or relocated, and even revalidatingprofessionals.[26][27] Re-validation may also be con-ducted when/where a change occurs during thecourses of activities, such as scientific researchesor phases of clinical trial transitions. Examples ofthese changes could be

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3

sample matrices[28][29]

production scales[30][31]

population profiles and sizes[32][33]

out-of-specification] (OOS) investigations,due to the contamination of testing reagents,glasswares, the aging of equipment/devices,or the depreciation of associated assetsetc.[34][35]

In GLP accredited laboratories, verifica-tion/revalidation will even be conducted veryoften against the monographs of the Ph.Eur.,IP to cater for multinational needs or USP andBP etc to cater for national needs.[36] Theselaboratories must have method validation aswell.[37]

Concurrent validation conducted during a routineprocessing of services, manufacturing or engineer-ing etc. Examples of these could be

duplicated sample analysis for a chemicalassay

triplicated sample analysis for trace impuritiesat the marginalized levels of detection limit,or/and quantification limit

single sample analysis for a chemical assay by askilled operator with multiplicated online sys-tem suitability testings

4 Aspects of validation

Themost tested attributes in validation tasks may include,but are not limited to

Selectivity/specificity

Accuracy and precision

Repeatability

Reproducibility

Limit of detection especially for trace elements

Limit of quantification

Curve fitting and its range

System suitability In a broad way, it usu-ally includes a test of ruggedness among inter-collaborators, or a test of robustness within an or-ganization [38][39][40] However, the U.S. Food andDrug Administration (FDA) has specifically definedit for its administration, as System suitability test-ing is an integral part of many analytical procedures.

The tests are based on the concept that the equip-ment, electronics, analytical operations and sam-ples to be analyzed constitute an integral systemthat can be evaluated as such. System suitabilitytest parameters to be established for a particularprocedure depend on the type of procedure beingvalidated.[41] In some cases of analytical chemistry,a system suitability test could be rather a methodspecific than universal. Such examples are chro-matographic analysis, which is usually media (col-umn, paper or mobile solvent) sensitive [42][43][44]However to the date of this writing, this kind ofapproaches are limited to some of pharmaceuticalcompendial methods, by which the detecting of im-purities, or the quality of the intest analyzed are crit-ical (i.e., life and death). This is probably largely dueto

their intensive labouring demands andtime consumption [45]

their confinements by the definition of theterm defined by different standards.

To solve this kind of difficulties, some regu-latory bodies or compendial methods usuallyprovide the advices on what the circumstancesor conditions that the performing of a speci-fied system suitability test should be beared andcompulsory.

5 Industry references

These terms generally apply broadly across industries andinstitutions. In addition, they may have very specificmeanings and requirements for specific products, regu-lations, and industries. Some examples:

Software and computer systemsMain article: Verification and validation (software)

Food and Drug Pharmaceuticals The design, production, anddistribution of drugs are highly regulated. Thisincludes software systems. For example in theUSA, the Food and Drug Administration haveregulations in Part 21 of the Code of FederalRegulations.[46] Nash et al. have published abook which provides a comprehensive cover-age on the various validation topics of phar-maceutical manufacturing processes.[47] Somecompanies are taking a risk-based approach tovalidating their GAMP system if one under-stands the regulatory requirements very wellwhile the most of others follows the conven-tional process [48][49] It is a part of GxP man-agement. The aspects of validation and verifi-cation are even more intense and emphasized

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4 9 NOTES AND REFERENCES

if an OOS occurs.[50] Very often under this cir-cumstance, a multiplicated sample analysis isrequired for conducting the OOS investigationin a testing laboratory.

Medical devices The FDA (21 CFR) has vali-dation and verification requirements for med-ical devices. See guidance:[46][51][52][53] andISO 13485

Manufacturing process and cleaning validationare compulsory and regulated by theU.S. Foodand Drug Administration [9][54][55][56]

Food hygiene: example [57]

Clinical laboratory medicine: ISO15198:2004 Clinical laboratory medicineInvitro diagnostic medical devicesValidationof user quality control procedures by themanufacturer

Main article: Validation (drug manufacture)

Health care: example [58]

Greenhouse gas: ISO 14064 ANSI/ISO: Green-house gases Requirements for greenhouse gasvalidation and verification bodies for use in accred-itation or other forms of recognition

Traffic and transport

Road safety audit Periodic motor vehicle inspection Aircraft noise: example [59]

Aircraft:

Model:

(Ni-Cd) cells: example [60]

ICT Industry: example [61]

Civil engineering

Buildings Roads Bridges

Economics

Accounting

Agriculture applications vary from verifying agri-cultural methodology and production processes tovalidating agricultural modeling [62][63][64][65][66]

Real estate appraisal audit reporting andauthentication [67]

6 See also

Accreditation

Change control

Certification of voting machines

Comparability

Cross-validation

Formal verification

Integrity Testing

ISO 17025

System testing

Systematic political science

Usability testing

Functional verification

Verification and Validation (software)

Verification and Validation of Computer SimulationModels

7 Further reading

Majcen, N.; Taylor, P. (2010). Practical examples ontraceability, measurement uncertainty and validation inchemistry 1 (ISBN 9789279120213). EuropeanUnion. p. 217.

8 External links

Maturity of verification and validation in ICT com-panies

Organisational maturity and functional performance

9 Notes and references[1] Global Harmonization Task Force - Quality Man-

agement Systems - Process Validation Guidance(GHTF/SG3/N99-10:2004 (Edition 2) page 3

[2] IEEE. IEEE Guide--Adoption of the Project Man-agement Institute (PMI) Standard A Guide tothe Project Management Body of Knowledge(PMBOK Guide)--Fourth Edition. p. 452.doi:10.1109/IEEESTD.2011.6086685. Retrieved 7December 2012.

[3] Barry Boehm, Software Engineering Economics, 1981

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5

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[9] Guideline on general principles of process validation.U.S. Food and Drug Administration. Retrieved 12 July2008.

[10] Prospective validation. Groupe Novasep. Retrieved 24September 2008.

[11] Quinn, James et al.; McDermott, D; Stiell, I; Kohn, M;Wells, G (2006). Prospective Validation of the San Fran-cisco Syncope Rule to Predict Patients With Serious Out-comes. Annals of Emergency Medicine (Elsevier) 47 (5):448454. doi:10.1016/j.annemergmed.2005.11.019.PMID 16631985.

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[13] Germing, U. et al.; Strupp, C; Kuendgen, A; Isa, S; Knipp,S; Hildebrandt, B; Giagounidis, A; Aul, C et al. (2006).Prospective validation of the WHO proposals for theclassification of myelodysplastic syndromes. Haemato-logica 91 (12): 15961604. PMID 17145595. Retrieved24 September 2008.

[14] Sciolla, Rossella et al.; Melis, F; Sinpac, Group (2008).Rapid Identification of High-Risk Transient IschemicAttacks: Prospective Validation of the ABCD Score.Stroke (American Heart Association) 39 (2): 297302. doi:10.1161/STROKEAHA.107.496612. PMID18174479.

[15] Pfisterer, Matthias et al.; Bertel, O; Bonetti, P; Brunner-larocca, H; Eberli, F; Erne, P; Galatius, S; Hornig, B et al.(2008). Drug-eluting or bare-metal stents forlarge coro-nary vessel stenting? The BASKET-PROVE (PROspec-tive Validation Examination) trial: Study protocol and de-sign. American Heart Journal (Mosby-Year Book Inc.)115 (4): 609614. doi:10.1016/j.ahj.2007.11.011. Re-trieved 24 September 2008.

[16] Van Geest-Daalderop, Johanna H. H. et al.; Hutten, Bar-bara A.; Pquriaux, Nathalie C. V.; Levi, Marcel; Sturk,Augueste (2008). Improvement in the regulation of thevitamin K antagonist acenocoumarol after a standard ini-tial dose regimen: prospective validation of a prescrip-tion model. Journal of Thrombosis and Thrombolysis

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[17] Ames, D. et al.; Keogh, A.M.; Adams, J.; Harrigan, S.;Allen, N. (1996). Prospective validation of the EBAS-DEPA short sensitive screening instrument for depres-sion in the physically ill elderly. European Psychiatry(Elsevier) 11 (Supplement 4): 361s. doi:10.1016/0924-9338(96)89148-6.

[18] Kidwell, Chelsea S. et al.; Starkman, S; Eckstein, M;Weems, K; Saver, JL (2000). Identifying Stroke in theField: Prospective Validation of the Los Angeles Prehos-pital Stroke Screen (LAPSS)". Stroke (American HeartAssociation) 31 (1): 7176. doi:10.1161/01.str.31.1.71.PMID 10625718. Retrieved 24 September 2008.

[19] U.S. Food and Drug Administration. Ch. 4 PROCESSVALIDATION in Medical Device Quality Systems Man-ual". Retrieved 6 August 2009.

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[21] Vieth, Erich. Who changed the Bible and why? BartEhrmans startling answers. Retrieved 28 August 2013.

[22] Arlandson, James M. Domestic violence in Islam. Re-trieved 17 October 2008.

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[24] Kluger, Michael D. et al. Retrospective Validation of aSurveillance System for Unexplained Illness and Death:New Haven County, Connecticut. Retrieved 26 Septem-ber 2008.

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6 9 NOTES AND REFERENCES

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8 10 TEXT AND IMAGE SOURCES, CONTRIBUTORS, AND LICENSES

10 Text and image sources, contributors, and licenses

10.1 Text Verification and validation Source: http://en.wikipedia.org/wiki/Verification_and_validation?oldid=629834356 Contributors: Deb,

Nealmcb, Michael Hardy, Rp, Hankwang, Ralph Corderoy, Mdd, Walter Grlitz, Arthena, Tyz, Pol098, BD2412, Rjwilmsi, GroundZero, Gaius Cornelius, Lyrl, Sardanaphalus, SmackBot, Edgar181, Chris the speller, Thumperward, Deli nk, Baa, Antonielly, Hu12,Wizard191, Pfagerburg, Baiji, MessedRobot, N2e, Pgr94, Headbomb, Mr pand, Time3000, VoABot II, Igor.passchier, R'n'B, Rlshee-han, Inwind, Starrymessenger, Brianga, Rchughtai, Nopetro, Bpeps, ClueBot, Doug.hoffman, Muhandes, Jonverve, Johnuniq, Jytdog,Avoided, DepartedUser4, Addbot, SpellingBot, TutterMouse, CanadianLinuxUser, Wireless friend, TundraGreen, JakobVoss, Alfie66,Luckas-bot, TaBOT-zerem, AnomieBOT, Piano non troppo, Citation bot, MithrasPriest, Maxis ftw, LilHelpa, Capricorn42, LordArtemis,Shirik, FrescoBot, Thayts, Oashi, Citation bot 1, Pinethicket, Gulbenk, JSo9-10, RjwilmsiBot, DexDor, Jeffspc88mx, JackStoneS, Sus-tainableengineering, RustyRoad, ZroBot, H3llBot, MajorVariola, Crm1003, Donner60, Ego White Tray, ClueBot NG, MelbourneStar,Amr.rs, RichardOSmith, Helpful Pixie Bot, HMSSolent, Wbm1058, Ramaksoud2000, Ninabhm, PhnomPencil, Altar, T.hetton, BattyBot,HairyWoodpecker, Btd7, Kuldeepsheoran1, Rcbart, Bizioo, Onpeters, Jixtacom, Monkbot and Anonymous: 131

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Overview Activities Categories of validationAspects of validation Industry referencesSee alsoFurther readingExternal linksNotes and references Text and image sources, contributors, and licensesTextImagesContent license