Verification and Validation

Verification & Validation is the process of checking that a product, service, or system meets specifications and that it fulfils its intended purpose. These are critical components of a quality management system such as ISO 9000.

Terminology

Verification is a quality process that is used to evaluate whether or not a product, service, or system complies with a regulation, specification, 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.

Validation is the process of establishing documented evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance and suitability with external customers.

It is sometimes said that validation can be expressed by the query‘Are you building the right thing?’ and verification by ‘Are you building the thing right?’. 'Building the right thing' refers back to the user's needs, while 'building it right' checks that the documented development process was followed. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.

Activities

Verification of machinery and equipment usually consists of "Design Qualification" - DQ cite web
last = Validation Online
first =
authorlink =
coauthors =
title = DESIGN QUALIFICATION
work =
publisher =
date =
url = http://www.validation-online.net/design-qualification.html
format =
doi =
accessdate = 17 March
accessyear = 2008 ] , "Installation Qualification" - IQ cite web
last = Validation Online
first =
authorlink =
coauthors =
title = INSTALLATION QUALIFICATION
work =
publisher =
date =
url = http://www.validation-online.net/installation-qualification.html
format =
doi =
accessdate = 17 March
accessyear = 2008 ] , "Operational Qualification" - OQ cite web
last = Validation Online
first =
authorlink =
coauthors =
title = OPERATIONAL QUALIFICATION
work =
publisher =
date =
url = http://www.validation-online.net/operational-qualification.html
format =
doi =
accessdate = 17 March
accessyear = 2008 ] and "Performance Qualification" - PQ cite web
last = Validation Online
first =
authorlink =
coauthors =
title = PERFORMANCE QUALIFICATION
work =
publisher =
date =
url = http://www.validation-online.net/performance-qualification.html
format =
doi =
accessdate = 17 March
accessyear = 2008 ] . DQ is usually a vendor's job. However, DQ can also be performed by the user, by confirming through review and testing that the equipment meets the written acquisition specification. If the relevant document or manuals of machinery/equipment are provided by vendors, the later 3Q needs to be thoroughly performed by the users who work in an industrial regulatory environment. Otherwise, the process of IQ, OQ and PQ is the task of validation. The typical example of such a case could be the loss or absence of vendor's documentation for legacy equipment or DIY assemblies (i.e. 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 "step-by-step" series if the acquisition of machinery/equipment is not bundled with on- site qualification services. This kind of the DIY approach is also applicable to the qualifications of software, computer operating systems and a manufacturing process. The most important and critical task as the last step of the activity is to generating and archiving machinery/equipment qualification reports for auditing purposes, if regulatory compliances are mandatory. At the same time, one should bear in mind to kindly share the original work with others, if the activity, especially validation of newly invented machinery/equipment, is worth of publishing.

Qualification of machinery/equipment is venue dependent and re-qualification needs to be conducted once the objects are relocated. The full scales of some equipment qualifications are even time dependent, and hence re-certification is necessary when a specified due time laps cite web
last = Analytical & Precision Balance Co.
first =
authorlink =
coauthors =
title = Welcome
work =
publisher =
date =
url = http://www.analyticalandprecision.com/
format =
doi =
accessdate = 18 March
accessyear = 2008 ] ^, cite web
last = Scientech
first =
authorlink =
coauthors =
title = External Calibration
work =
publisher =
date =
url = http://www.scalenet.com/scientech/factors.html
format =
doi =
accessdate = 18 March
accessyear = 2008 ] . Re-qualification 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 affects especially the pre-settings, such as on BIOS, registry, disk drive partition table, or an ini file etc, have been necessary. In such a situation, the specifications of the parts/devices/software and restructuring proposals should be appended to the qualification document whether 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 effects cite web
last = Torres
first = Rebecca E.
authorlink =
coauthors = William A. Hyman
title = Replacement Parts-Identical, Suitable, or Inappropriate?
work =
publisher =
date = 2007
url = http://pt.wkhealth.com/pt/re/jce/abstract.00004669-200710000-00028.htm;jsessionid=HnHfvQKXh1nGWbpxR9LsvgcGQQ1111QBXgnq7ncT2Fvfrvh38CL9!923867264!181195629!8091!-1
format =
doi =
accessdate = 29 March
accessyear = 2008 ] . In the case when genuine parts/devices/software are demanded by some of regulatory requirements, then re-qualification should not be conducted on the non genuine assemblies. In stead, the asset has to be recycled for non regulatory purposes.

When machinery/equipment qualification is conducted by a standard endorsed third party such as by an ISO standard accredited company for a particular division, the process is called certification cite web
last = AppLabs
first =
authorlink =
coauthors =
title = ISV, IHV Certification Programs
work =
publisher =
date =
url = http://www.applabs.com/html/certificationprograms.html
format =
doi =
accessdate = 26 March
accessyear = 2008 ] ^, cite web
last = AppLabs
first =
authorlink =
coauthors =
title = AppLabs attains ISO27001:2005 accreditation
work =
publisher =
date =
url = http://www.applabs.com/html/ISO270012005Accreditation_230.html
format =
doi =
accessdate = 26 March
accessyear = 2008 ] . Currently, the coverage of ISO/IEC 15408 certification by an ISO/IEC 27001 accredited organization is limited, the scheme requires a fair amount of efforts to get popularized.

Categories & aspects of validation

Validation work can generally be catogrized by the following functions:

* Prospective validation - the missions conducted before new items are released to make sure the characteristics of the interests which are functional properly and which meet the safety standards cite web
last = U.S. Food and Drug Administration
first =
authorlink =
coauthors =
title = GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION
work =
publisher =
date =
url = http://www.fda.gov/CDER/GUIDANCE/pv.htm
format =
doi =
accessdate = 24 September
accessyear = 2008 ] ^, cite web
last = Groupe Novasep
first =
authorlink =
coauthors =
title = Prospective validation
work =
publisher =
date =
url = http://www.novasep.com/misc/glossary.asp?defId=169&lookfor=&search=P
format =
doi =
accessdate = 24 September
accessyear = 2008 ] . Some examples could be legislative rules, guidelines or proposals cite journal
last = Quinn
first = James "et al."
authorlink =
coauthors =
title = Prospective Validation of the San Francisco Syncope Rule to Predict Patients With Serious Outcomes
journal = Annals of Emergency Medicine
volume = 47
issue = 5
pages = 448 - 454
publisher = Elsevier
date = 2006
url =
doi = 10.1016/j.annemergmed.2005.11.019
accessdate = 24 September
accessyear = 2008 ] ^, cite journal
last = Sangiovanni
first = A. "et al."
authorlink =
coauthors =
title = Prospective validation of AASLD guidelines for the early diagnosis of hepatocellular carcinoma in cirrhotic patients
journal = Digestive and Liver Disease
volume = 40
issue = 5
pages = A22 - A23
publisher = Elsevier
date = 2007
url =
doi = 10.1016/j.dld.2007.12.064
accessdate = 24 September
accessyear = 2008 ] ^, cite journal
last = Germing
first = U. "et al."
authorlink =
coauthors =
title = Prospective validation of the WHO proposals for the classification of myelodysplastic syndromes
journal = Haematologica
volume = 91
issue = 12
pages = 1596 - 1604
publisher =
date = 2006
url = http://haematologica.org/cgi/content/abstract/91/12/1596
doi =
accessdate = 24 September
accessyear = 2008 ] , methods cite journal
last = Sciolla
first = Rossella "et al."
authorlink =
coauthors =
title = Rapid Identification of High-Risk Transient Ischemic Attacks: Prospective Validation of the ABCD Score
journal = Stroke
volume = 39
issue = 2
pages = 297 - 302
publisher = American Heart Association
date = 2008
url =
doi = 10.1161/STROKEAHA.107.496612
accessdate = 24 September
accessyear = 2008 ] , theories/hypothesis/models cite journal
last = Pfisterer
first = Matthias "et al."
authorlink =
coauthors =
title = Drug-eluting or bare-metal stents forlarge coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design
journal = American Heart Journal
volume = 115
issue = 4
pages = 609 - 614
publisher = Mosby-Year Book Inc
date = 2008
url = http://pt.wkhealth.com/pt/re/amhj/abstract.00000406-200804000-00005.htm;jsessionid=LZBJTyL1zvPbLLyTqcYVCLhhfJ3KWKKXjvkTn91r3c1vJYyDhpWR!1455807198!181195628!8091!-1
doi =
accessdate = 24 September
accessyear = 2008 ] ^, cite journal
last = Van Geest-Daalderop
first = Johanna H. H. "et al."
authorlink =
coauthors =
title = Improvement in the regulation of the vitamin K antagonist acenocoumarol after a standard initial dose regimen: prospective validation of a prescription model
journal = Journal of Thrombosis and Thrombolysis
volume =
issue =
pages =
publisher = Springer
date = 2008
url =
doi = 10.1007/s11239-008-0203-4
accessdate = 24 September
accessyear = 2008 ] , products and services cite journal
last = Ames
first = D. "et al."
authorlink =
coauthors =
title = Prospective validation of the EBAS-DEP -- A short sensitive screening instrument for depression in the physically ill elderly
journal = European Psychiatry
volume = 11
issue = Supplement 4,
pages = 361s
publisher = Elsevier
date = 1996
url =
doi = 10.1016/0924-9338(96)89148-6
accessdate = 24 September
accessyear = 2008 ] ^, cite journal
last = Kidwell
first = Chelsea S. "et al."
authorlink =
coauthors =
title = Identifying Stroke in the Field: Prospective Validation of the Los Angeles Prehospital Stroke Screen (LAPSS)
journal = Stroke
volume = 31
issue =
pages = 71 -76
publisher = American Heart Association
date = 2000
url = http://stroke.ahajournals.org/cgi/content/abstract/strokeaha;31/1/71
doi =
accessdate = 24 September
accessyear = 2008 ]
* 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 missing, then the work can not be processed or can only be completed partially ^, cite web
last = U.S. Food and Drug Administration
first =
authorlink =
coauthors =
title = Ch. 4 PROCESS VALIDATION in "Medical Device Quality Systems Manual"
work =
publisher =
date =
url = http://www.fda.gov/cdrh/qsr/04valid.html
format =
doi =
accessdate = 24 September
accessyear = 2008 ] ^, cite web
last = Groupe Novasep
first =
authorlink =
coauthors =
title = Retrospective validation
work =
publisher =
date =
url = http://www.novasep.com/misc/glossary.asp?defId=185&lookfor=&search=R
format =
doi =
accessdate = 24 September
accessyear = 2008 ] . The tasks are considered necessary cite web
last = Validation-online.net
first =
authorlink =
coauthors =
title = Retrospective validation Rationale
work =
publisher =
date =
url = http://www.validation-online.net/retrospective-validation.html
format =
doi =
accessdate = 24 September
accessyear = 2008 ] if
** prospective validation is missing, inadequate or flawed.
** the change of legislative regulations or standards affects the compliance of the items being released to the public or market.
** reviving of out-of-use itemsSome of the examples could be validating of the ancient scriptures that contain controversies cite web
last = Vieth
first = Erich
authorlink =
coauthors =
title = Who changed the Bible and why? Bart Ehrman’s startling answers
work =
publisher =
date =
url = http://www.dangerousintersection.org/?p=668
format =
doi =
accessdate = 26 September
accessyear = 2008 ] , clinical decision rules cite journal
last = Hart
first = D.
authorlink =
coauthors = S.W. Smith
title = Retrospective Validation of a Clinical Decision Rule to Safely Rule Out Subarachnoid Hemorrhage in Emergency Department Headache Patients
journal = Annals of Emergency Medicine
volume = 50
issue = 3
pages = S102-S103
publisher =
date = 2007
url =
doi = 10.1016/j.annemergmed.2007.06.388
accessdate = 26 September
accessyear = 2008 ] , data systems cite web
last = Kluger
first = Michael D. "et al."
authorlink =
coauthors =
title = Retrospective Validation of a Surveillance System for Unexplained Illness and Death: New Haven County, Connecticut
work =
publisher =
date =
url = http://www.ajph.org/cgi/content/abstract/91/8/1214
format =
doi =
accessdate = 26 September
accessyear = 2008 ] ^, cite web
last = Fine
first = Leon G. "et al."
authorlink =
coauthors =
title = How to evaluate and improve the quality and credibility of an outcomes database: validation and feedback study on the UK Cardiac Surgery Experience
work =
publisher =
date =
url = http://www.bmj.com/cgi/content/abstract/326/7379/25
format =
doi =
accessdate = 26 September
accessyear = 2008 ] etc.
* Full scale validation
* 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 range.
* 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 laps. Examples of this category could be relicencing/renewing driver's license, recertifying an analytical balance that has been expired or relocated, and even revalidating professionals cite web
last = Department of Health (United Kingdom)
first =
authorlink =
coauthors =
title = The White Paper Trust, assurance and safety: The regulation of health professionals
work =
publisher =
date =
url = http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_065946
format =
doi =
accessdate = 30 September
accessyear = 2008 ] ^, cite web
last = Merkur
first = Sherry
authorlink =
coauthors =
title = Physician revalidation in Europe
work =
publisher = Royal College of Physicians
date =
url = http://www.ingentaconnect.com/content/rcop/cm/2008/00000008/00000004/art00005
format =
doi =
accessdate = 30 September
accessyear = 2008 ] .
* Concurrent validation - conducted during a routine processing of services, manufacturing or engineering etc. Example of these could be duplicated sample analysis, single sample analysis with multiplicated online system suitability testings

The most tested attributes in the validation taskes may include

* Selectivity/specificity
* Accuracy
* Precision/Repeatability
* Reproducibility
* Curve fitting
* System suitability - In a broad way, it usually includes a test of ruggedness among inter-colaborators or a test of robustness within an organization cite web
last = Health Sciences Authority
first =
authorlink =
coauthors =
title = Guidance Notes on Analytical Method Validation: Methodology
work =
publisher =
date =
url = http://depa.pquim.unam.mx/amyd/archivero/Singapur:HSAGUIDE-MQA-012B-004Guidenotesonanalyticalmethodvalidation_2006.pdf
format =
doi =
accessdate = 29 September
accessyear = 2008 ] ^, cite journal
last = Heyden
first = Y. Vander "et al."
authorlink =
coauthors = S.W. Smith
title = Guidance for robustness/ruggedness tests in method validation
journal = Journal of Pharmaceutical and Biomedical Analysis
volume = 24
issue = 5 - 6
pages = 723 - 753
publisher = Elsevier
date = 2001
url =
doi = 10.1016/S0731-7085(00)00529-X
accessdate = 29 September
accessyear = 2008 ] ^, cite book
last = Ermer
first = Joachim
authorlink =
coauthors = John H. McB. Miller
title = Method Validation in Pharmaceutical Analysis: A Guide to best Practice
publisher = Wiley-VCH
date = 2005
location =
pages = 418
url =
doi =
id =
isbn = 3527312552
accessdate = 29 September
accessyear = 2008] . However, 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." A good example is provided by the company of GMP ONLINE CONSULTANCY and the test requires certified standards if a compendial method is to be used cite web
last = GMP ONLINE CONSULTANCY
first =
authorlink =
coauthors =
title = Calibration of dissolution test apparatus (USP apparatus 1 and 2) - SOP
work =
publisher =
date =
url = http://www.gmp-online-consultancy.com/e/html/301_direct_order/210_standard-operation-procedures_detail.php?docIndex=113
format =
doi =
accessdate = 29 September
accessyear = 2008 ] .

Industry references

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:

* Software and computer systems main|Verification and Validation (software)
* 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 [http://www.fda.gov/CDER/GUIDANCE/pv.htm] . Nash "et al." have published a book which provides a comprehensive coverage on the various validation topics of pharmaceutical manufacturing processes cite book
last = Nash
first = Robert A. "et al."
authorlink =
coauthors =
title = Pharmaceutical Process Validation: An International Third Edition
publisher = Informa Healthcare
date = 2003
location =
pages = 860
url =
doi =
id =
isbn = 0824708385] . 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 cite web
last = De Caris
first = Sandro "et al."
authorlink =
coauthors =
title = Risk-based equipment qualification: a user/supplier cooperative approach
work =
publisher =
date =
url = http://www.gampforum.it/documenti/articolo-per-pharmaceutical-engineering/07mj-online_de_caris.pdf
format =
doi =
accessdate = 15 June
accessyear = 2008 ] ^, cite journal
last = Ocampo
first = Arlene "et al."
authorlink =
coauthors =
title = 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
journal = The Quality Assurance Journal
volume = 11
issue = 1
pages = 3 - 15
publisher = John Wiley & Sons
date = 2007
url =
doi = 10.1002/qaj.399
accessdate = 15 June
accessyear = 2008 ] . It is a part of GxP management.
** Medical devices The FDA (21 CFR) has validation and verification requirements for medical devices. . See guidance: [http://www.fda.gov/CDER/GUIDANCE/pv.htm] and ISO 13485
** Manufacturing process and cleaning validation are compulsory and regulated by FDA cite web
last = Food and Drug Administration
first =
authorlink =
coauthors =
title = GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION
work =
publisher =
date =
url = http://www.fda.gov/CDER/GUIDANCE/pv.htm
format =
doi =
accessdate = 16 March
accessyear = 2008 ] ^, cite web
last = Food and Drug Administration
first =
authorlink =
coauthors =
title = GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES
work =
publisher =
date =
url = http://www.fda.gov/ora/Inspect_ref/igs/valid.html
format =
doi =
accessdate = 20 March
accessyear = 2008 ] ^, cite web
last = Nassani
first = Mowafak
authorlink =
coauthors =
title = Cleaning validation in the pharmaceutical industry
work =
publisher =
date =
url = http://cat.inist.fr/?aModele=afficheN&cpsidt=16985392
format =
doi =
accessdate = 20 March
accessyear = 2008 ] ^, cite web
last = Bharadia
first = Praful D.
authorlink =
coauthors = Jignyasha A. Bhatt
title = A review of current implementation strategies for validation of cleaning processes in the pharmaceutical industry
work =
publisher =
date =
url = http://cat.inist.fr/?aModele=afficheN&cpsidt=17762178
format =
doi =
accessdate = 20 March
accessyear = 2008 ] .
** Food hygiene: example [http://www.fsis.usda.gov/OPHS/NACMCF/2002/FHControl.pdf]
** Clinical laboratory medicine: ISO 15198:2004 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer

* Health care: example [http://www.transfusionguidelines.org.uk/docs/pdfs/oig_tools_qa_bb_e-issue_validation.pdf]

* Greenhouse gas: ISO 14064 ANSI/ISO: Greenhouse gases — Requirements for greenhouse gas validation and verification bodies for use in accreditation or other forms of recognition
* Traffic and transport
** Road safety audit
** Periodic motor vehicle inspection
**Aircraft noise: example [http://www.caa.co.uk/docs/68/in01_731.pdf]
**Aircraft: [http://ieeexplore.ieee.org/Xplore/login.jsp?url=/iel5/9579/30294/01391292.pdf]
* Model: [http://www.lanl.gov/projects/ei/model_v/about.shtml]
* (Ni-Cd) cells: example [http://ieeexplore.ieee.org/xpl/freeabs_all.jsp?arnumber=905101]
* ICT Industry: example [http://www.inderscience.com/search/index.php?action=record&rec_id=16630]
* Civil engineering
** Buildings -
** Roads -
** Bridges -
* Economics
** ??? -
* Accounting
** ??? -
* Agriculture - applications vary from verifying agricultural methodology and production processes to validating agricultural modeling cite web
last = Masako
first = Tsujimoto
authorlink =
coauthors =
title = 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 ).
work =
publisher =
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url = http://sciencelinks.jp/j-east/article/200006/000020000699A0878565.php
format =
doi =
accessdate = 20 March
accessyear = 2008 ] ^, cite web
last = Vollmer-Sanders
first = Carrie Lynn "et al."
authorlink =
coauthors =
title = Implications of the Voluntary Michigan Agriculture Environmental Assurance Program (MAEAP) Verification on Livestock Operations, 2000-2004
work =
publisher =
date =
url = http://asae.frymulti.com/abstract.asp?aid=23866&t=2
format =
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accessdate = 20 March
accessyear = 2008 ] ^, cite journal
last = Haboudane
first = Driss "et al."
authorlink =
coauthors =
title = Hyperspectral vegetation indices and novel algorithms for predicting green LAI of crop canopies: Modeling and validation in the context of precision agriculture
journal = Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement
volume = 90
issue = 3
pages = 337 - 352
publisher = Elsevier
date = 2004
url =
doi = 10.1016/j.rse.2003.12.013
accessdate = 20 March
accessyear = 2008 ] ^, cite web
last = Thorp
first = Kelly "et al."
authorlink =
coauthors =
title = USING CROSS-VALIDATION TO EVALUATE CERES-MAIZE YIELD SIMULATIONS WITHIN A DECISION SUPPORT SYSTEM FOR PRECISION AGRICULTURE
work =
publisher =
date =
url = http://www.ars.usda.gov/research/publications/publications.htm?seq_no_115=214367
format =
doi =
accessdate = 20 March
accessyear = 2008 ] ^, cite web
last = Randolph
first = Susan "et al."
authorlink =
coauthors =
title = Monitoring the Realization of the Right to Food: Adaptation and Validation of the U.S. Department of Agriculture Food Insecurity Module to Rural Senegal
work =
publisher =
date =
url = http://ideas.repec.org/p/uct/ecriwp/6.html
format =
doi =
accessdate = 20 March
accessyear = 2008 ] .
* Real estate appraisal - audit reporting and authentication cite web
last = Pruitt
first = Kirk
authorlink =
coauthors = Ryan Paul Chamberlain
title = Method and system for authenticating appraisal reports
work =
publisher =
date =
url = http://www.google.com.au/patents?hl=en&lr=&vid=USPATAPP11282205&id=nFOCAAAAEBAJ&oi=fnd&dq=validation+OR+verification+%22real+estate+appraisal%22
format =
doi =
accessdate = 15 September
accessyear = 2008 ]

Notes

ee also

* Atsec information security
* Accreditation
* Analytical Instrument Qualification - AIQ
* Change control
* Cross-validation
* European Centre for the Validation of Alternative Methods
* Integrity Testing
* ISO 17025
* Sustainability testing
* System testing
* Syncretism
* Usability testing
* Validation
* Validation (drug manufacture)
* Verification
* Verification and Validation (software)