Verication and validation

IV&V redirects here. For NASAs IV&V Facility, see Validation is intended to ensure a product, service, or sysIndependent Verication and Validation Facility.
tem (or portion thereof, or set thereof) result in a product, service, or system (or portion thereof, or set thereof)
Verication and validation are independent procedures that meets the operational needs of the user. For a new
development ow or verication ow, validation procethat are used together for checking that a product, service, or system meets requirements and specications dures may involve modeling either ow and using simulations to predict faults or gaps that might lead to invalid
and that it fullls its intended purpose.[1] These are critical components of a quality management system such as or incomplete verication or development of a product,
ISO 9000. The words verication and validation are service, or system (or portion thereof, or set thereof). A
sometimes preceded with independent, indicating that set of validation requirements (as dened by the user),
the verication and validation is to be performed by a dis- specications, and regulations may then be used as a basis
interested third party. Independent verication and val- for qualifying a development ow or verication ow for
a product, service, or system (or portion thereof, or set
idation can be abbreviated as "IV&V".
thereof). Additional validation procedures also include
In practice, the usage of these terms varies. Sometimes those that are designed specically to ensure that modithey are even used interchangeably.
cations made to an existing qualied development ow or
The PMBOK guide, a standard adopted by IEEE, denes verication ow will have the eect of producing a product, service, or system (or portion thereof, or set thereof)
them as follows in its 4th edition:[2]
that meets the initial design requirements, specications,
Validation. The assurance that a product, service, and regulations; these validations help to keep the ow
or system meets the needs of the customer and other qualied. It is a process of establishing evidence that proidentied stakeholders. It often involves acceptance vides a high degree of assurance that a product, service,
and suitability with external customers. Contrast or system accomplishes its intended requirements. This
often involves acceptance of tness for purpose with end
with verication.
users and other product stakeholders. This is often an
Verication. The evaluation of whether or not a external process.
product, service, or system complies with a regula- It is sometimes said that validation can be expressed by
tion, requirement, specication, or imposed condi- the query Are you building the right thing?"[3] and vertion. It is often an internal process. Contrast with ication by Are you building it right?".[3] Building the
validation.
right thing refers back to the users needs, while building it right checks that the specications are correctly
implemented by the system. In some contexts, it is re1 Overview
quired to have written requirements for both as well as
formal procedures or protocols for determining compliVerication is intended to check that a product, service, ance.
or system (or portion thereof, or set thereof) meets a set It is entirely possible that a product passes when veried
of design specications. In the development phase, ver- but fails when validated. This can happen when, say, a
ication procedures involve performing special tests to product is built as per the specications but the specicamodel or simulate a portion, or the entirety, of a product, tions themselves fail to address the users needs.
service or system, then performing a review or analysis
of the modeling results. In the post-development phase,
verication procedures involve regularly repeating tests
devised specically to ensure that the product, service, or 2 Activities
system continues to meet the initial design requirements,
specications, and regulations as time progresses. It is a Verication of machinery and equipment usually conprocess that is used to evaluate whether a product, ser- sists of design qualication (DQ), installation qualivice, or system complies with regulations, specications, cation (IQ), operational qualication (OQ), and perforor conditions imposed at the start of a development phase. mance qualication (PQ). DQ may be performed by a
Verication can be in development, scale-up, or produc- vendor or by the user, by conrming through review and
tion. This is often an internal process.
testing that the equipment meets the written acquisition
1

3 CATEGORIES OF VALIDATION

specication. If the relevant document or manuals of ma- 3 Categories of validation

chinery/equipment are provided by vendors, the later 3Q
needs to be thoroughly performed by the users who work Validation work can generally be categorized by the folin an industrial regulatory environment. Otherwise, the lowing functions:
process of IQ, OQ and PQ is the task of validation. The
typical example of such a case could be the loss or ab Prospective validation the missions conducted
sence of vendors documentation for legacy equipment
before new items are released to make sure
or do-it-yourself (DIY) assemblies (e.g., cars, computers
the characteristics of the interests which are
etc.) and, therefore, users should endeavour to acquire
functioning properly and which meet safety
DQ document beforehand. Each template of DQ, IQ, OQ
standards.[9][10] Some examples could be legislative
and PQ usually can be found on the internet respectively,
rules, guidelines or proposals,[11][12][13] methods,[14]
whereas the DIY qualications of machinery/equipment
theories/hypothesis/models[15][16] products and
can be assisted either by the vendors training course maservices[17][18]
terials and tutorials, or by the published guidance books,
Retrospective validation a process for items that
such as step-by-step series if the acquisition of machinare already in use and distribution or production.
ery/equipment is not bundled with on- site qualication
The validation is performed against the written
services. This kind of the DIY approach is also applicable
specications or predetermined expectations, based
to the qualications of software, computer operating sysupon their historical data/evidences that are docutems and a manufacturing process. The most important
mented/recorded. If any critical data is missing,
and critical task as the last step of the activity is to genthen the work can not be processed or can only be
erating and archiving machinery/equipment qualication
completed partially.[9][19][20] The tasks are considreports for auditing purposes, if regulatory compliances
ered necessary if:
are mandatory.
Qualication of machinery/equipment is venue dependent, in particular items that are shock sensitive and require balancing or calibration, and re-qualication needs
to be conducted once the objects are relocated. The
full scales of some equipment qualications are even
time dependent as consumables are used up (i.e. lters) or springs stretch out, requiring recalibration, and
hence re-certication is necessary when a specied due
time lapse.[4][5] Re-qualication of machinery/equipment
should also be conducted when replacement of parts,
or coupling with another device, or installing a new
application software and restructuring of the computer
which aects especially the pre-settings, such as on
BIOS, registry, disk drive partition table, dynamicallylinked (shared) libraries, or an ini le etc., have been
necessary. In such a situation, the specications of the
parts/devices/software and restructuring proposals should
be appended to the qualication document whether the
parts/devices/software are genuine or not. Torres and Hyman have discussed the suitability of non genuine parts
for clinical use and provided guidelines for equipment
users to select appropriate substitutes which are capable to avoid adverse eects.[6] In the case when genuine
parts/devices/software are demanded by some of regulatory requirements, then re-qualication does not need to
be conducted on the non genuine assemblies. Instead, the
asset has to be recycled for non regulatory purposes.
When machinery/equipment qualication is conducted
by a standard endorsed third party such as by an ISO standard accredited company for a particular division, the
process is called certication.[7][8] Currently, the coverage of ISO/IEC 15408 certication by an ISO/IEC 27001
accredited organization is limited, the scheme requires a
fair amount of eorts to get popularized.

prospective validation is missing, inadequate

or awed.
the change of legislative regulations or standards aects the compliance of the items being released to the public or market.
reviving of out-of-use items.
Some of the examples could be validation of:
ancient
scriptures
that
controversial[21][22]
clinical decision rules[23]
data systems[24][25]

remain

Full-scale validation
Partial validation often used for research and pilot
studies if time is constrained. The most important
and signicant eects are tested. From an analytical
chemistry perspective, those eects 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 dismissed, repaired, integrated/coupled, relocated, or
after a specied time lapse. Examples of this
category could be relicencing/renewing drivers license, recertifying an analytical balance that has
been expired or relocated, and even revalidating
professionals.[26][27] Re-validation may also be conducted when/where a change occurs during the
courses of activities, such as scientic researches
or phases of clinical trial transitions. Examples of
these changes could be

3
sample matrices[28][29]
production scales

[30][31]

population proles and sizes[32][33]

out-of-specication] (OOS) investigations,
due to the contamination of testing reagents,
glasswares, the aging of equipment/devices,
or the depreciation of associated assets
etc.[34][35]
In GLP accredited laboratories, verication/revalidation will even be conducted very
often against the monographs of the Ph.Eur.,
IP to cater for multinational needs or USP and
BP etc to cater for national needs.[36] These
laboratories must have method validation as
well.[37]
Concurrent validation conducted during a routine
processing of services, manufacturing or engineering etc. Examples of these could be
duplicated sample analysis for a chemical
assay
triplicated sample analysis for trace impurities
at the marginalized levels of detection limit,
or/and quantication limit
single sample analysis for a chemical assay by a
skilled operator with multiplicated online system suitability testings

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.[41] In some cases of analytical chemistry,
a system suitability test could be rather a method
specic than universal. Such examples are chromatographic analysis, which is usually media (column, paper or mobile solvent) sensitive [42][43][44]
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
their intensive labouring demands and
time consumption [45]
their connements by the denition of the
term dened by dierent standards.
To solve this kind of diculties, some regulatory bodies or compendial methods usually
provide the advices on what the circumstances
or conditions that the performing of a specied system suitability test should be beared and
compulsory.

5 Industry references

These terms generally apply broadly across industries and

institutions. In addition, they may have very specic
meanings and requirements for specic products, reguThe most tested attributes in validation tasks may include, lations, and industries. Some examples:
but are not limited to
Software and computer systems
Main article: Verication and validation (software)
Selectivity/specicity

Aspects of validation

Accuracy and precision

Repeatability
Reproducibility
Limit of detection especially for trace elements
Limit of quantication
Curve tting and its range
System suitability In a broad way, it usually includes a test of ruggedness among intercollaborators, or a test of robustness within an organization [38][39][40] However, the U.S. Food and
Drug Administration (FDA) has specically dened
it for its administration, as System suitability testing is an integral part of many analytical procedures.

Food and Drug

Pharmaceuticals The design, production, and
distribution of drugs are highly regulated. This
includes software systems. For example in the
USA, the Food and Drug Administration have
regulations in Part 21 of the Code of Federal
Regulations.[46] Nash et al. have published a
book which provides a comprehensive coverage on the various validation topics of pharmaceutical manufacturing processes.[47] Some
companies are taking a risk-based approach to
validating their GAMP system if one understands the regulatory requirements very well
while the most of others follows the conventional process [48][49] It is a part of GxP management. The aspects of validation and verication are even more intense and emphasized

9
if an OOS occurs.[50] Very often under this circumstance, a multiplicated sample analysis is
required for conducting the OOS investigation
in a testing laboratory.
Medical devices The FDA (21 CFR) has validation and verication requirements for medical devices. See guidance:[46][51][52][53] and
ISO 13485

6 See also
Accreditation
Change control
Certication of voting machines
Comparability

Manufacturing process and cleaning validation

are compulsory and regulated by the U.S. Food
and Drug Administration [9][54][55][56]

Cross-validation

Food hygiene: example

Integrity Testing

[57]

Clinical laboratory medicine:

ISO
15198:2004 Clinical laboratory medicineIn
vitro diagnostic medical devicesValidation
of user quality control procedures by the
manufacturer
Main article: Validation (drug manufacture)

NOTES AND REFERENCES

Formal verication

ISO 17025
System testing
Systematic political science
Usability testing
Functional verication

Health care: example [58]

Greenhouse gas: ISO 14064 ANSI/ISO: Greenhouse gases Requirements for greenhouse gas
validation and verication bodies for use in accreditation or other forms of recognition

Verication and Validation (software)

Verication and Validation of Computer Simulation
Models

7 Further reading

Trac and transport

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

Majcen, N.; Taylor, P. (2010). Practical examples on

traceability, measurement uncertainty and validation in
chemistry 1 (ISBN 9789279120213). European
Union. p. 217.

Aircraft:

8 External links

Model:
(Ni-Cd) cells: example [60]
ICT Industry: example

[61]

Civil engineering
Buildings
Roads
Bridges
Economics
Accounting
Agriculture applications vary from verifying agricultural methodology and production processes to
validating agricultural modeling [62][63][64][65][66]
Real estate appraisal audit reporting and
authentication [67]

Maturity of verication and validation in ICT companies

Organisational maturity and functional performance

9 Notes and references

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(GHTF/SG3/N99-10:2004 (Edition 2) page 3
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the Project Management Body of Knowledge
p.
452.
(PMBOK Guide)--Fourth Edition.
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Retrieved 7
December 2012.
[3] Barry Boehm, Software Engineering Economics, 1981

[4] Analytical & Precision Balance Co. Welcome. Retrieved 18 March 2008.

(Springer) 27 (2): 207. doi:10.1007/s11239-008-02034.

[5] Scientech. External Calibration. Retrieved 18 March

2008.

[17] Ames, D. et al.; Keogh, A.M.; Adams, J.; Harrigan, S.;

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[6] Torres, Rebecca E.; William A. Hyman (2007).

Replacement Parts-Identical, Suitable, or Inappropriate?". Retrieved 29 March 2008.
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from the original on 16 February 2008. Retrieved 26
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2008.
[10] Prospective validation. Groupe Novasep. Retrieved 24
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(2007). Prospective validation of AASLD guidelines for
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(2008). Drug-eluting or bare-metal stents forlarge coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design. American Heart Journal (Mosby-Year Book Inc.)
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Augueste (2008). Improvement in the regulation of the
vitamin K antagonist acenocoumarol after a standard initial dose regimen: prospective validation of a prescription model. Journal of Thrombosis and Thrombolysis

[18] Kidwell, Chelsea S. et al.; Starkman, S; Eckstein, M;

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of a Clinical Decision Rule to Safely Rule Out Subarachnoid Hemorrhage in Emergency Department Headache
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[29] Bressolle, Franoise et al.; Brometpetit, M; Audran, M
(1996). Validation of liquid chromatographic and gas
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[31] del Rosario Alemn, Mara (2007). Downstream Processing: A Revalidation Study of Viral Clearance in the
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[32] El Eman, Khaled et al.; Brown, A; Abdelmalik, P (2009).
Evaluating Predictors of Geographic Area Population
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NOTES AND REFERENCES

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Hu, ZB (2004). Ruggedness/robustness evaluation and
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principles of FDA GLP and FDA GMP to bioanalytical
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[36] Food and Drug Administration (United States) (May

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[50] Guidance for Industry:

Investigating Out-ofSpecication (OOS) Test Results for Pharmaceutical
Production (PDF). Food and Drug Administration
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[66] Randolph, Susan et al. Monitoring the Realization of the
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10

10
10.1

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HairyWoodpecker, Btd7, Kuldeepsheoran1, Rcbart, Bizioo, Onpeters, Jixtacom, Monkbot and Anonymous: 131

10.2

Images

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artist: ?
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10.3

Content license

Creative Commons Attribution-Share Alike 3.0