Verification and validation

Verification is intended to check that a product, service, or system meets a set of design specifications."Systems and software engineering - Vocabulary," ISO/IEC/IEEE std 24765:2010(E), 2010. | verification 5. ...product, service, or system complies with a regulation, requirement, specification, or imposed condition.{{Citation |title=IEEE 1012-2004 |year=2004 |page=9 |publisher=IEEE}} In the development phase, verification procedures involve performing special tests to model 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 continues to meet the initial design requirements, specifications, and regulations as time progresses."Systems and software engineering - Vocabulary," ISO/IEC/IEEE 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, operation, and maintenance) It is a process that is used to evaluate whether a product, service, or system complies with regulations, specifications, 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.{{cn|date=August 2023}}

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."Systems and software engineering - Vocabulary," ISO/IEC/IEEE std 24765:2010(E), 2010. | validation (especially 1. & 2.) For a new development flow or verification flow, validation procedures may 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).{{Cite book|last1=Moradi|first1=Mehrdad|last2=Van Acker|first2=Bert|last3=Vanherpen|first3=Ken|last4=Denil|first4=Joachim|title=Cyber Physical Systems. Model-Based Design |chapter=Model-Implemented Hybrid Fault Injection for Simulink (Tool Demonstrations) |date=2019|editor-last=Chamberlain|editor-first=Roger|editor2-last=Taha|editor2-first=Walid|editor3-last=Törngren|editor3-first=Martin|series=Lecture Notes in Computer Science|volume=11615|language=en|location=Cham|publisher=Springer International Publishing|pages=71–90|doi=10.1007/978-3-030-23703-5_4|isbn=978-3-030-23703-5|s2cid=195769468|chapter-url=https://figshare.com/articles/preprint/Model-Implemented_Hybrid_Fault_Injection_for_Simulink_Tool_Demonstrations_/12479930 }} 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.{{Citation needed|date=January 2012}} 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.{{cn|date=August 2023}}

It is sometimes said that validation can be expressed by the query "Are you building the right thing?"Barry Boehm, Software Engineering Economics, 1981 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 the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.{{cn|date=August 2023}}

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.{{cn|date=August 2023}}

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 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 do-it-yourself (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 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.{{cn|date=August 2023}}

Qualification of machinery/equipment is venue dependent, in particular items that are shock sensitive and require balancing or calibration, 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 stretch out, requiring recalibration, and hence re-certification is necessary when a specified due time lapse.{{Cite web |url=http://www.analyticalandprecision.com/ |title=Welcome |last=Analytical & Precision Balance Co. |access-date=18 March 2008}}{{Cite web |url=http://www.scalenet.com/scientech/factors.html |title=External Calibration |last=Scientech |access-date=18 March 2008 |archive-date=29 January 2020 |archive-url=https://web.archive.org/web/20200129091219/http://www.scalenet.com/scientech/factors.html |url-status=dead }} 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, dynamically-linked (shared) libraries, 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 of avoiding adverse effects.{{Cite web |url=http://pt.wkhealth.com/pt/re/jce/abstract.00004669-200710000-00028.htm;jsessionid=HnHfvQKXh1nGWbpxR9LsvgcGQQ1111QBXgnq7ncT2Fvfrvh38CL9!923867264!181195629!8091!-1 |title=Replacement Parts-Identical, Suitable, or Inappropriate? |last1=Torres |first1=Rebecca E. |last2=William A. Hyman |year=2007 |access-date=29 March 2008}} 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.{{cn|date=August 2023}}

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 |url=http://www.applabs.com/html/certificationprograms.html |title=ISV, IHV Certification Programs |last=AppLabs |archive-url=https://web.archive.org/web/20080216214101/http://www.applabs.com/html/certificationprograms.html |archive-date=16 February 2008 |access-date=26 March 2008}}{{Cite web |url=http://www.applabs.com/html/ISO270012005Accreditation_230.html |title=AppLabs attains ISO27001:2005 accreditation |last=AppLabs |access-date=26 March 2008 |archive-date=12 March 2008 |archive-url=https://web.archive.org/web/20080312101857/http://applabs.com/html/ISO270012005Accreditation_230.html |url-status=dead }} 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.

Validation work can generally be categorized by the following functions:

• 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.{{Cite web |url=https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm |title=Guideline on general principles of process validation |publisher=U.S. Food and Drug Administration |url-status=dead |archive-url=https://web.archive.org/web/20090606085627/https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm |archive-date=6 June 2009 |access-date=12 July 2008}}{{Cite web |url=http://www.novasep.com/misc/glossary.asp?defId=169&lookfor=&search=P |title=Prospective validation |publisher=Groupe Novasep |access-date=24 September 2008 |archive-date=15 November 2008 |archive-url=https://web.archive.org/web/20081115185842/http://www.novasep.com/misc/glossary.asp?defId=169&lookfor=&search=P |url-status=dead }} Some examples could be legislative rules, guidelines or proposals,{{Cite journal |last1=Quinn |first1=James |last2=McDermott |first2=D |last3=Stiell |first3=I |last4=Kohn |first4=M |last5=Wells |first5=G |display-authors=etal |year=2006 |title=Prospective Validation of the San Francisco Syncope Rule to Predict Patients With Serious Outcomes |journal=Annals of Emergency Medicine |publisher=Elsevier |volume=47 |issue=5 |pages=448–454 |doi=10.1016/j.annemergmed.2005.11.019 |pmid=16631985}}{{Cite journal |last1=Sangiovanni |first1=A. |last2=Manini |first2=M |last3=Iavarone |first3=M |last4=Fraquelli |first4=M |last5=Forzenigo |first5=L |last6=Romeo |first6=R |last7=Ronchi |first7=G |last8=Colombo |first8=M |display-authors=etal |year=2007 |title=Prospective validation of AASLD guidelines for the early diagnosis of epatocellular carcinoma in cirrhotic patients |journal=Digestive and Liver Disease |publisher=Elsevier |volume=40 |issue=5 |pages=A22–A23 |doi=10.1016/j.dld.2007.12.064}}{{Cite journal |last1=Germing |first1=U. |last2=Strupp |first2=C |last3=Kuendgen |first3=A |last4=Isa |first4=S |last5=Knipp |first5=S |last6=Hildebrandt |first6=B |last7=Giagounidis |first7=A |last8=Aul |first8=C |last9=Gattermann |first9=N |last10=Haas |first10=R |display-authors=1 |year=2006 |title=Prospective validation of the WHO proposals for the classification of myelodysplastic syndromes |url=http://haematologica.org/cgi/content/abstract/91/12/1596 |journal=Haematologica |volume=91 |issue=12 |pages=1596–1604 |pmid=17145595 |access-date=24 September 2008 |archive-date=12 November 2010 |archive-url=https://web.archive.org/web/20101112080910/http://www.haematologica.org/cgi/content/abstract/91/12/1596 |url-status=dead }} methods,{{Cite journal |last1=Sciolla |first1=Rossella |last2=Melis |first2=F |last3=Sinpac |first3=Group |display-authors=etal |year=2008 |title=Rapid Identification of High-Risk Transient Ischemic Attacks: Prospective Validation of the ABCD Score |journal=Stroke |publisher=American Heart Association |volume=39 |issue=2 |pages=297–302 |doi=10.1161/STROKEAHA.107.496612 |pmid=18174479|doi-access=free }} theories/hypothesis/models,{{Cite journal |last1=Pfisterer |first1=Matthias |last2=Bertel |first2=O |last3=Bonetti |first3=P |last4=Brunnerlarocca |first4=H |last5=Eberli |first5=F |last6=Erne |first6=P |last7=Galatius |first7=S |last8=Hornig |first8=B |last9=Kiowski |first9=W |last10=Pachinger |first10=Otmar |last11=Pedrazzini |first11=Giovanni |display-authors=1 |year=2008 |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 |publisher=Mosby-Year Book Inc. |volume=115 |issue=4 |pages=609–614 |doi=10.1016/j.ahj.2007.11.011 |pmid=18371466 |last12=Rickli |first12=Hans |last13=De Servi |first13=Stefano |last14=Kaiser |first14=Christoph}}{{Cite journal |last1=Van Geest-Daalderop |first1=Johanna H. H. |last2=Hutten |first2=Barbara A. |last3=Péquériaux |first3=Nathalie C. V. |last4=Levi |first4=Marcel |last5=Sturk |first5=Augueste |display-authors=etal |year=2008 |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 |publisher=Springer |volume=27 |issue=2 |pages=207–14 |doi=10.1007/s11239-008-0203-4 |pmid=18270659|doi-access=free }} products and services.{{Cite journal |last1=Ames |first1=D. |last2=Keogh |first2=A.M. |last3=Adams |first3=J. |last4=Harrigan |first4=S. |last5=Allen |first5=N. |display-authors=etal |year=1996 |title=Prospective validation of the EBAS-DEP – A short sensitive screening instrument for depression in the physically ill elderly |journal=European Psychiatry |publisher=Elsevier |volume=11 |issue=Supplement 4 |pages=361s |doi=10.1016/0924-9338(96)89148-6|s2cid=58984986 }}{{Cite journal |last1=Kidwell |first1=Chelsea S. |last2=Starkman |first2=S |last3=Eckstein |first3=M |last4=Weems |first4=K |last5=Saver |first5=JL |display-authors=etal |year=2000 |title=Identifying Stroke in the Field: Prospective Validation of the Los Angeles Prehospital Stroke Screen (LAPSS) |journal=Stroke |publisher=American Heart Association |volume=31 |issue=1 |pages=71–76 |doi=10.1161/01.str.31.1.71 |pmid=10625718 |doi-access=free }}
• 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 |url=https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122439.htm |archive-url=https://web.archive.org/web/20090709184743/http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122439.htm |url-status=dead |archive-date=9 July 2009 |title=Ch. 4 PROCESS VALIDATION in Medical Device Quality Systems Manual |last=U.S. Food and Drug Administration |website=Food and Drug Administration |author-link=U.S. Food and Drug Administration |access-date=6 August 2009}}{{Cite web |url=http://www.novasep.com/misc/glossary.asp?defId=185&lookfor=&search=R |title=Retrospective validation |last=Groupe Novasep |access-date=24 September 2008 |archive-date=15 November 2008 |archive-url=https://web.archive.org/web/20081115132813/http://www.novasep.com/misc/glossary.asp?defId=185&lookfor=&search=R |url-status=dead }} The tasks are considered necessary 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 items.

: Some of the examples could be validation of:

:* ancient scriptures that remain controversial{{citation needed|date=August 2021}}

:* clinical decision rules{{Cite journal |last1=Hart |first1=D. |last2=S.W. Smith |year=2007 |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 |doi=10.1016/j.annemergmed.2007.06.388}}

:* data systems{{Cite journal |last=Kluger |first=Michael D. |display-authors=etal |year=2001 |title=Retrospective Validation of a Surveillance System for Unexplained Illness and Death: New Haven County, Connecticut |journal=American Journal of Public Health |volume=91 |issue=8 |pages=1214–1219 |doi=10.2105/AJPH.91.8.1214 |pmc=1446748 |pmid=11499106}}{{Cite journal |last=Fine |first=Leon G. |display-authors=etal |year=2003 |title=How to evaluate and improve the quality and credibility of an outcomes database: validation and feedback study on the UK Cardiac Surgery Experience |journal=BMJ |volume=326 |issue=7379 |pages=25–28 |doi=10.1136/bmj.326.7379.25 |pmc=139501 |pmid=12511458 }}

• 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.
• 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 specified time lapse. Examples of this category could be relicensing/renewing driver's license, recertifying an analytical balance that has been expired or relocated, and even revalidating professionals.{{Cite web |url=http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_065946 |title=The White Paper Trust, assurance and safety: The regulation of health professionals |last=Department of Health |author-link=Department of Health (United Kingdom) |access-date=30 September 2008 |archive-date=5 October 2012 |archive-url=https://web.archive.org/web/20121005014051/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_065946 |url-status=dead }}{{Cite journal |last=Merkur |first=Sherry |title=Physician revalidation in Europe |journal=Clinical Medicine |volume=8 |issue=4 |pages=371–6 |publisher=Royal College of Physicians |pmid=18724601 |pmc=4952927 |year=2008 |doi=10.7861/clinmedicine.8-4-371 }} Re-validation may also be conducted when/where a change occurs during the courses of activities, such as scientific researches or phases of clinical trial transitions. Examples of these changes could be
• sample matrices{{Cite web |url=http://permits.nra.gov.au/publications/guidelines/docs/gl_69_analytical_methods.pdf |title=Guidelines for the Validation of Analytical Methods for Active Constituent, Agricultural and Veterinary Chemical Products |last=Australian Pesticides & Veterinary Medicines Authority |author-link=Australian Pesticides & Veterinary Medicines Authority |year=2004 |access-date=12 July 2009 |archive-date=20 February 2011 |archive-url=https://web.archive.org/web/20110220012542/http://permits.nra.gov.au/publications/guidelines/docs/gl_69_analytical_methods.pdf |url-status=dead }}{{Cite journal |last1=Bressolle |first1=Françoise |last2=Brometpetit |first2=M |last3=Audran |first3=M |display-authors=etal |year=1996 |title=Validation of liquid chromatographic and gas chromatographic methods Applications to pharmacokinetics |journal=Journal of Chromatography B |volume=686 |issue=1 |pages=3–10 |doi=10.1016/S0378-4347(96)00088-6 |pmid=8953186}}
• production scales{{Cite web |url=http://www.peptisyntha.com/processdevelopment/commercialscaleproduction/0,,3660-2-0,00.htm |title=Commercial scale production |last=Peptisyntha S.A. |year=2009 |url-status=dead |archive-url=https://web.archive.org/web/20090531024300/http://www.peptisyntha.com/processdevelopment/commercialscaleproduction/0,,3660-2-0,00.htm |archive-date=31 May 2009 |access-date=12 July 2009}}{{Cite web |url=http://biopharminternational.findpharma.com/biopharm/article/articleDetail.jsp?id=395611 |title=Downstream Processing: A Revalidation Study of Viral Clearance in the Purification of Monoclonal Antibody CB.Hep-1 |last=del Rosario Alemán |first=María |year=2007 |access-date=12 July 2009 |archive-date=11 July 2011 |archive-url=https://web.archive.org/web/20110711003357/http://biopharminternational.findpharma.com/biopharm/article/articleDetail.jsp?id=395611 |url-status=dead }}
• population profiles and sizes{{Cite journal |last1=El Eman |first1=Khaled |last2=Brown |first2=A |last3=Abdelmalik |first3=P |display-authors=etal |year=2009 |title=Evaluating Predictors of Geographic Area Population Size Cut-offs to Manage Re-identification Risk |journal=Journal of the American Medical Informatics Association |volume=16 |issue=2 |pages=256–266 |doi=10.1197/jamia.M2902 |pmc=2649314 |pmid=19074299}}{{Cite journal |last1=Tollman |first1=Stephen M |last2=Kahn |first2=Kathleen |last3=Sartorius |first3=Benn |last4=Collinson |first4=Mark A |last5=Clark |first5=Samuel J |last6=Garenne |first6=Michel L |display-authors=etal |year=2008 |title=Implications of mortality transition for primary health care in rural South Africa: a population-based surveillance study |journal=Journal of the American Medical Informatics Association |volume=372 |issue=9642 |pages=893–901 |doi=10.1016/S0140-6736(08)61399-9 |pmc=2602585 |pmid=18790312}}
• out-of-specification] (OOS) investigations, due to the contamination of testing reagents, glasswares, the aging of equipment/devices, or the depreciation of associated assets etc.{{Cite web |url=https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm085293.pdf |archive-url=https://web.archive.org/web/20090710120619/http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm085293.pdf |url-status=dead |archive-date=10 July 2009 |title=Warning Letter (WL No. 320-08-04) |last=United States Department of Health & Human Services |website=Food and Drug Administration |author-link=United States Department of Health & Human Services |year=2009 |access-date=12 July 2009}}{{Cite web |url=http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/validation/gui_29-eng.php |title=Validation Guidelines for Pharmaceutical Dosage Forms (GUIDE-0029) |last=Health Canada |author-link=Health Canada |year=2004 |access-date=12 July 2009}}

:In GLP accredited laboratories, verification/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.{{Cite web |url=https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry |title=Guidance for Industry: Bioanalytical Method Validation |last=Food and Drug Administration |website=Food and Drug Administration |author-link=Food and Drug Administration (United States) |date=May 2001 |access-date=12 July 2009}} These laboratories must have method validation as well.Method Validation; {{Cite web |url=http://www.caspharma.com/Method-Validation/ |title=Method Validation |url-status=dead |archive-url=https://web.archive.org/web/20110911212217/http://www.caspharma.com/Method-Validation/ |archive-date=11 September 2011 |access-date=19 September 2011}}

• 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 quantification limit
• single sample analysis for a chemical assay by a skilled operator with multiplicated online system suitability testings

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

• Sensitivity and specificity
• Accuracy and precision
• Repeatability
• Reproducibility
• Limit of detection – especially for trace elements
• Limit of quantification
• Curve fitting and its range
• 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 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.

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. 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.

In a broad way, it usually includes a test of ruggedness among inter-collaborators, or a test of robustness within an organization{{Cite web |url=http://depa.pquim.unam.mx/amyd/archivero/Singapur:HSAGUIDE-MQA-012B-004Guidenotesonanalyticalmethodvalidation_2006.pdf |title=Guidance Notes on Analytical Method Validation: Methodology |last=Health Sciences Authority |author-link=Health Sciences Authority |access-date=29 September 2008 |archive-date=18 February 2012 |archive-url=https://web.archive.org/web/20120218210429/http://depa.pquim.unam.mx/amyd/archivero/Singapur:HSAGUIDE-MQA-012B-004Guidenotesonanalyticalmethodvalidation_2006.pdf |url-status=dead }}{{Cite journal |last1=Heyden |first1=Y. Vander |last2=S.W. Smith |display-authors=etal |year=2001 |title=Guidance for robustness/ruggedness tests in method validation |journal=Journal of Pharmaceutical and Biomedical Analysis |publisher=Elsevier |volume=24 |issue=5–6 |pages=723–753 |doi=10.1016/S0731-7085(00)00529-X |pmid=11248467|s2cid=14334288 }}{{Cite book |last1=Ermer |first1=Joachim |title=Method Validation in Pharmaceutical Analysis: A Guide to best Practice |last2=John H. McB. Miller |publisher=Wiley-VCH |year=2005 |isbn=978-3-527-31255-9 |page=418}} However, the U.S. Food and Drug Administration (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".{{Cite web |title=Calibration of dissolution test apparatus (USP apparatus 1 and 2) – SOP}} In some cases of analytical chemistry, 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{{Cite journal |last1=Szsz |first1=Gy. |last2=Gyimesi-Forrás |first2=K. |last3=Budvári-Bárány |first3=Zs. |display-authors=etal |year=1998 |title=Optimized and Validated HPLC Methods for Compendial Quality Assessment. III. Testing of Optical Purity Applying 1-Acid-Glycoprotein Stationary Phase |journal=Journal of Liquid Chromatography & Related Technologies |volume=21 |issue=16 |pages=2535–2547 |doi=10.1080/10826079808003597}}{{Cite web |url=http://www.chem.agilent.com/Library/applications/5989-8333EN.pdf |title=System suitability testing for Aripiprazole quality control with the Agilent 1120 Compact LC and ZORBAX C-18 columns |last=Agilent |author-link=Agilent |access-date=29 June 2009 |archive-date=5 February 2015 |archive-url=https://web.archive.org/web/20150205163754/http://www.chem.agilent.com/Library/applications/5989-8333EN.pdf |url-status=dead }}{{Cite journal |last1=Li |first1=Yong-guo |last2=Chen |first2=M |last3=Chou |first3=GX |last4=Wang |first4=ZT |last5=Hu |first5=ZB |display-authors=etal |year=2004 |title=Ruggedness/robustness evaluation and system suitability test on United States Pharmacopoeia XXVI assay ginsenosides in Asian and American ginseng by high-performance liquid chromatography |journal=Journal of Pharmaceutical and Biomedical Analysis |volume=35 |issue=5 |pages=1083–1091 |doi=10.1016/j.jpba.2004.04.005 |pmid=15336355}} 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{{Cite web |url=http://jpdb.nihs.go.jp/jp15e/ |title=Japanese Pharmacopoeia |last=日本药局方 |access-date=29 June 2009 |archive-date=9 April 2008 |archive-url=https://web.archive.org/web/20080409121703/http://jpdb.nihs.go.jp/jp15e/ |url-status=dead }}{{Clarify|date=July 2009}}{{Cite journal|title=Optimizing fault injection in FMI co-simulation through sensitivity partitioning {{!}} Proceedings of the 2019 Summer Simulation Conference|url=https://dl.acm.org/doi/abs/10.5555/3374138.3374170|access-date=2020-06-15|website=dl.acm.org|date=22 July 2019 |pages=1–12 |language=EN}}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).

:* their confinements by the definition of the term defined by different standards.

: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.

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|Software verification and validation}}
• Food and drug manufacturing
• Pharmaceuticals
• {{Main|Validation (drug manufacture)}}
• 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.{{Cite web |url=https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm |title=GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION |date=May 1987 |website=FDA |archive-url=https://web.archive.org/web/20090606085627/https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm |archive-date=6 June 2009}} 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. |title=Pharmaceutical Process Validation: An International Third Edition |publisher=Informa Healthcare |year=2003 |isbn=978-0-8247-0838-2 |page=860 |display-authors=etal}} 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 |url=http://www.gampforum.it/documenti/articolo-per-pharmaceutical-engineering/07mj-online_de_caris.pdf |title=Risk-based equipment qualification: a user/supplier cooperative approach |last=De Caris |first=Sandro |access-date=15 June 2008 |display-authors=etal}}{{Cite journal |last1=Ocampo |first1=Arlene |last2=Lum |first2=Steven |last3=Chow |first3=Frank |display-authors=etal |year=2007 |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 |publisher=John Wiley & Sons |volume=11 |issue=1 |pages=3–15 |doi=10.1002/qaj.399|doi-access=free }} It is a part of GxP management. The aspects of validation and verification are even more intense and emphasized if an OOS occurs.{{Cite web |url=https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf |archive-url=https://web.archive.org/web/20090709211224/http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf |url-status=dead |archive-date=9 July 2009 |title=Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production |year=2006 |publisher=Food and Drug Administration |access-date=12 July 2009}} 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 verification requirements for medical devices, as outlined in ASME V&V 40. Also see guidance:{{Cite web |url=https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077823.pdf |archive-url=https://web.archive.org/web/20090710165205/http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077823.pdf |url-status=dead |archive-date=10 July 2009 |title=Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software |date=14 January 2005 |publisher=Food and Drug Administration |access-date=12 July 2009}}{{Cite web |url=https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085371.pdf |archive-url=https://web.archive.org/web/20090617013539/http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM085371.pdf |url-status=dead |archive-date=17 June 2009 |title=General Principles of Software validation; Final Guidance for Industry and FDA Staff |date=11 January 2002 |publisher=Food and Drug Administration |access-date=12 July 2009}}{{Cite web |url=https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-and-modernization-act-2002-validation-data-premarket-notification |title=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 |date=25 September 2006 |publisher=Food and Drug Administration |access-date=12 July 2009}} and ISO 13485. {{further|Validation and verification (medical devices)}}
• Manufacturing process and cleaning validation are compulsory and regulated by the U.S. Food and Drug Administration{{Cite web |url=https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm |title=Guideline on general principles of process validation |date=May 1987 |publisher=Food and Drug Administration |url-status=dead |archive-url=https://web.archive.org/web/20090720030042/https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm |archive-date=20 July 2009 |access-date=12 July 2009}}{{Cite web |url=https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074922.htm |archive-url=https://web.archive.org/web/20090612041054/http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074922.htm |url-status=dead |archive-date=12 June 2009 |title=Guide to inspections validation of cleaning processes |date=July 1993 |publisher=Food and Drug Administration |access-date=12 July 2009}}{{Cite journal |url=http://cat.inist.fr/?aModele=afficheN&cpsidt=16985392 |title=Cleaning validation in the pharmaceutical industry |last=Nassani |first=Mowafak |journal=Journal of Validation Technology |volume=11 |issue=4 |access-date=20 March 2008}}{{Cite web |url=http://cat.inist.fr/?aModele=afficheN&cpsidt=17762178 |title=A review of current implementation strategies for validation of cleaning processes in the pharmaceutical industry |last1=Bharadia |first1=Praful D. |last2=Jignyasha A. Bhatt |access-date=20 March 2008 |archive-date=31 May 2012 |archive-url=https://web.archive.org/web/20120531131315/http://cat.inist.fr/?aModele=afficheN&cpsidt=17762178 |url-status=dead }}
• Food hygiene: example{{Cite web |url=http://www.fsis.usda.gov/OPHS/NACMCF/2002/FHControl.pdf |title=Discussion Paper on Proposed Draft Guidelines for the Validation of Food Hygiene Control Measures |access-date=10 February 2011 |archive-date=11 October 2010 |archive-url=https://web.archive.org/web/20101011174823/http://www.fsis.usda.gov/OPHS/NACMCF/2002/FHControl.pdf |url-status=dead }}
• Clinical laboratory medicine: ISO 15198:2004 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer
• Engineering
• Engineering in general
• Engineering validation test
• Civil engineering
• Buildings –
• Roads –
• Bridges –
• Health care: example{{Cite web |url=http://www.transfusionguidelines.org.uk/docs/pdfs/oig_tools_qa_bb_e-issue_validation.pdf |title=Archived copy |url-status=dead |archive-url=https://web.archive.org/web/20071012043133/http://www.transfusionguidelines.org.uk/docs/pdfs/oig_tools_qa_bb_e-issue_validation.pdf |archive-date=12 October 2007 |access-date=14 June 2008}}
• 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{{Cite web |url=http://www.caa.co.uk/docs/68/in01_731.pdf |title=Archived copy |url-status=dead |archive-url=https://web.archive.org/web/20070927015752/http://www.caa.co.uk/docs/68/in01_731.pdf |archive-date=27 September 2007 |access-date=7 September 2007}}
• Aircraft:
• Model:{{Cite web | url=http://lanl.gov/projects/ei/model_v/about.shtml | archive-url=https://web.archive.org/web/20071013150443/http://lanl.gov/projects/ei/model_v/about.shtml| archive-date=13 October 2007| title=Service Unavailable}}
• (Ni-Cd) cells: example{{Cite book |last1=Manzo |first1=M.A. |title=Sixteenth Annual Battery Conference on Applications and Advances. Proceedings of the Conference (Cat. No.01TH8533) |last2=Strawn |first2=D.M. |last3=Hall |first3=S.W. |date=7 August 2002 |isbn=978-0-7803-6545-2 |pages=59–66 |chapter=Aerospace nickel-cadmium cell verification-final report |doi=10.1109/BCAA.2001.905101|s2cid=110489981 }}
• ICT Industry: example{{Cite web |url=http://www.inderscience.com/search/index.php?action=record&rec_id=16630 |title=Improving the efficiency of verification and validation |publisher=Inderscience.com |access-date=19 September 2011}}
• Accounting
• Agriculture – applications vary from verifying agricultural methodology and production processes to validating agricultural modeling{{Cite web |url=http://sciencelinks.jp/j-east/article/200006/000020000699A0878565.php |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). |last=Masako |first=Tsujimoto |access-date=20 March 2008 |archive-date=17 February 2012 |archive-url=https://web.archive.org/web/20120217004341/http://sciencelinks.jp/j-east/article/200006/000020000699A0878565.php |url-status=dead }}{{Cite web |url=http://asae.frymulti.com/abstract.asp?aid=23866&t=2 |title=Implications of the Voluntary Michigan Agriculture Environmental Assurance Program (MAEAP) Verification on Livestock Operations, 2000–2004 |last=Vollmer-Sanders |first=Carrie Lynn |access-date=20 March 2008 |display-authors=etal |archive-date=11 July 2011 |archive-url=https://web.archive.org/web/20110711045916/http://asae.frymulti.com/abstract.asp?aid=23866&t=2 |url-status=dead }}{{Cite journal |last=Haboudane |first=Driss |display-authors=etal |year=2004 |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 |publisher=Elsevier |volume=90 |issue=3 |pages=337–352 |bibcode=2004RSEnv..90..337H |doi=10.1016/j.rse.2003.12.013}}{{Cite web |url=http://www.ars.usda.gov/research/publications/publications.htm?seq_no_115=214367 |title=Using cross-validation to evaluate ceres-maize yield simulations within a decision support system for precision agriculture |last=Thorp |first=Kelly |access-date=20 March 2008 |display-authors=etal}}{{Cite journal |last=Randolph |first=Susan |display-authors=etal |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 |url=http://ideas.repec.org/p/uct/ecriwp/6.html |journal=Economic Rights Working Papers |date=October 2007 |volume=6 |access-date=20 March 2008}}
• Real estate appraisal – audit reporting and authentication{{Cite web |url=https://www.google.com.au/patents?hl=en&lr=&vid=USPATAPP11282205&id=nFOCAAAAEBAJ&oi=fnd&dq=validation+OR+verification+%22real+estate+appraisal%22 |title=Method and system for authenticating appraisal reports |last1=Pruitt |first1=Kirk |last2=Ryan Paul Chamberlain |access-date=15 September 2008 |archive-date=29 June 2011 |archive-url=https://web.archive.org/web/20110629040155/http://www.google.com.au/patents?hl=en&lr=&vid=USPATAPP11282205&id=nFOCAAAAEBAJ&oi=fnd&dq=validation+OR+verification+%22real+estate+appraisal%22 |url-status=dead }}
• Arms control

{{div col|colwidth=30em}}

• Certification of voting machines
• Change control
• Comparability
• Data validation
• Formal verification
• Functional verification
• ISO 17025
• Positive recall
• Process validation
• Software verification and validation
• Statistical model validation
• System testing
• Usability testing
• Validation master plan
• Verification and validation of computer simulation models

{{div col end}}

{{Reflist}}

• {{Cite book |last1=Majcen |first1=N. |title=Practical examples on traceability, measurement uncertainty and validation in chemistry |last2=Taylor |first2=P. |publisher=European Union |year=2010 |isbn=978-92-79-12021-3 |volume=1 |page=217}}

• [http://www.inderscience.com/search/index.php?action=record&rec_id=21681&prevQuery=&ps=10&m=or Maturity of verification and validation in ICT companies]
• [http://www.inderscience.com/search/index.php?action=record&rec_id=22624&prevQuery=&ps=10&m=or Organisational maturity and functional performance]

{{Systems Engineering}}

{{Authority control}}

{{DEFAULTSORT:Verification And Validation}}

Category:Quality management

Category:Product testing

Category:Systems engineering

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