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| Overview | |
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Verification is a quality assurance process[dubious – discuss]intended to check that a product, service, or system (or portion thereof, or set thereof) meets a set of initial design requirements, specifications, and regulations. 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.[citation needed] 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.
Validation is a quality control process[dubious – discuss] intended to check that development and verification procedures for a product, service, or system (or portion thereof, or set thereof) result in a product, service, or system (or portion thereof, or set thereof) that meets initial requirements, specifications, and regulations. 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). A set of validation requirements, 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] 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.
It is sometimes said that validation can be expressed by the query "Are you building the right thing?"[1] and verification by "Are you building it right?"[1] "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.
[edit] Tags:Edit,Quality Assurance,Specifications,Quality Control, | |
| Activities | |
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Verification of machinery and equipment usually consists of Design Qualification – DQ,[2] Installation Qualification – IQ,[3] Operational Qualification – OQ [4] and Performance Qualification – PQ.[5] 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 do-it-yourself (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.
Qualification of machinery/equipment is venue dependent, in particular items that are shock sensitive and require balancing or calibration,[why?] 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[why?], and hence re-certification is necessary when a specified due time lapse.[6][7] 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.[8] 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.
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.[9][10] 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.
[edit] Tags:Do-it-yourself,Application Software,Bios,Registry,Disk Drive Partition Table,Ini File,Iso,Iso/iec 15408,Iso/iec 27001,Ip,Software, | |
| Categories of verification and validation | |
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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.[11][12] Some examples could be legislative rules, guidelines or proposals,[13][14][15] methods,[16] theories/hypothesis/models[17][18] products and services[19][20]
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.[11][21][22] The tasks are considered necessary[23] 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 controversies[24][25]
clinical decision rules[26]
data systems[27][28]
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 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.[29][30] 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[31][32]
production scales[33][34]
population profiles and sizes[35][36]
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.[37][38]
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.[39] These laboratories must have method validation as well.[40]
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 an chemical assay by a skilled operator with multiplicated online system suitability testings
[edit] Tags:Cross-validation,Analytical Balance,Clinical Trial,Population,Depreciation,Glp,Monographs,Ph.eur.,Usp,Bp,Assay,Detection Limit,Selectivity,Accuracy,Repeatability,Analytical Chemistry, | |
| Aspects of validation | |
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The most tested attributes in validation tasks may include, but are not limited to
Selectivity/specificity
Accuracy
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 usually includes a test of ruggedness among inter-collaborators, or a test of robustness[disambiguation needed ] within an organization [41][42][43] 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".[44] 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 [45][46][47] 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., live and death). This is probably largely due to
their intensive labouring demands and time consumption [48][clarification needed]
their confinements by the definition of the term defined by different standards.
To solve this kind of difficulties, some regulatory bodies or compendial methods usually provide the advices on what the circumstances or conditions that the performing of a specified system suitability test should be beared and compulsory.
[edit] Tags:Specificity,Precision,Reproducibility,Limit Of Detection,Limit Of Quantification,Curve Fitting,U.s. Food And Drug Administration, | |
| Industry references | |
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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 article: 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.[49] Nash et al. have published a book which provides a comprehensive coverage on the various validation topics of pharmaceutical manufacturing processes.[50] 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 [51][52] It is a part of GxP management. The aspects of validation and verification are even more intense and emphasized if an OOS occurs.[53] 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. See guidance:[49][54][55][56] and ISO 13485
Manufacturing process and cleaning validation are compulsory and regulated by the U.S. Food and Drug Administration [11][57][58][59]
Food hygiene: example [60]
Clinical laboratory medicine: ISO 15198:2004 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer
Main article: Validation (drug manufacture)
Health care: example [61]
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 [62]
Aircraft:[2]
Model:[3]
(Ni-Cd) cells: example [63]
ICT Industry: example [64]
Civil engineering
Buildings –
Roads –
Bridges –
Economics
Accounting
Agriculture – applications vary from verifying agricultural methodology and production processes to validating agricultural modeling [65][66][67][68][69]
Real estate appraisal – audit reporting and authentication [70]
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| See also | |
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Accreditation
Change control
Certification of voting machines
Comparability
Cross-validation
Formal verification
Independent Verification and Validation Facility
Integrity Testing
ISO 17025
Specification (technical standard)
System testing
Systematic political science
Usability testing
Validation (drug manufacture)
Functional verification
Verification and Validation (software)
[edit] Tags: | |
| Further reading | |
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Majcen, N.; Taylor, P. (2010). Practical examples on traceability, measurement uncertainty and validation in chemistry. 1. European Union. p. 217.
[edit] Tags: | |
| External links | |
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Maturity of verification and validation in ICT companies
Organisational maturity and functional performance
[edit] Tags: | |
| Notes and references | |
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^ a b Barry boehm, Software Engineering and Economics, 1981
^ Validation Online. "Design qualification". http://www.validation-online.net/design-qualification.html. Retrieved 17 March 2008.
^ Validation Online. "Installation qualification". http://www.validation-online.net/installation-qualification.html. Retrieved 17 March 2008.
^ Validation Online. "Operational qualification". http://www.validation-online.net/operational-qualification.html. Retrieved 17 March 2008.
^ Validation Online. "Performance qualification". http://www.validation-online.net/performance-qualification.html. Retrieved 17 March 2008.
^ Analytical & Precision Balance Co.. "Welcome". http://www.analyticalandprecision.com/. Retrieved 18 March 2008.
^ Scientech. "External Calibration". http://www.scalenet.com/scientech/factors.html. Retrieved 18 March 2008.
^ Torres, Rebecca E.; William A. Hyman (2007). "Replacement Parts-Identical, Suitable, or Inappropriate?". http://pt.wkhealth.com/pt/re/jce/abstract.00004669-200710000-00028.htm;jsessionid=HnHfvQKXh1nGWbpxR9LsvgcGQQ1111QBXgnq7ncT2Fvfrvh38CL9!923867264!181195629!8091!-1. Retrieved 29 March 2008.
^ AppLabs. "ISV, IHV Certification Programs". Archived from the original on 16 February 2008. http://web.archive.org/web/20080216214101/http://www.applabs.com/html/certificationprograms.html. Retrieved 26 March 2008.
^ AppLabs. "AppLabs attains ISO27001:2005 accreditation". http://www.applabs.com/html/ISO270012005Accreditation_230.html. Retrieved 26 March 2008.
^ a b c "Guideline on general principles of process validation". U.S. Food and Drug Administration. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm. Retrieved 12 July 2008.
^ "Prospective validation". Groupe Novasep. http://www.novasep.com/misc/glossary.asp?defId=169&lookfor=&search=P. Retrieved 24 September 2008.
^ Quinn, James et al.; McDermott, D; Stiell, I; Kohn, M; Wells, G (2006). "Prospective Validation of the San Francisco Syncope Rule to Predict Patients With Serious Outcomes". Annals of Emergency Medicine (Elsevier) 47 (5): 448–454. doi:10.1016/j.annemergmed.2005.11.019. PMID 16631985.
^ Sangiovanni, A. et al.; Manini, M; Iavarone, M; Fraquelli, M; Forzenigo, L; Romeo, R; Ronchi, G; Colombo, M (2007). "Prospective validation of AASLD guidelines for the early diagnosis of epatocellular carcinoma in cirrhotic patients". Digestive and Liver Disease (Elsevier) 40 (5): A22–A23. doi:10.1016/j.dld.2007.12.064.
^ 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 the classification of myelodysplastic syndromes". Haematologica 91 (12): 1596–1604. PMID 17145595. http://haematologica.org/cgi/content/abstract/91/12/1596. Retrieved 24 September 2008.
^ Sciolla, Rossella et al.; Melis, F; Sinpac, Group (2008). "Rapid Identification of High-Risk Transient Ischemic Attacks: Prospective Validation of the ABCD Score". Stroke (American Heart Association) 39 (2): 297–302. doi:10.1161/STROKEAHA.107.496612. PMID 18174479.
^ Pfisterer, Matthias et al.; Bertel, O; Bonetti, P; Brunnerlarocca, H; Eberli, F; Erne, P; Galatius, S; Hornig, B et al. (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.) 115 (4): 609–614. doi:10.1016/j.ahj.2007.11.011. http://pt.wkhealth.com/pt/re/amhj/abstract.00000406-200804000-00005.htm;jsessionid=LZBJTyL1zvPbLLyTqcYVCLhhfJ3KWKKXjvkTn91r3c1vJYyDhpWR!1455807198!181195628!8091!-1. Retrieved 24 September 2008.
^ Van Geest-Daalderop, Johanna H. H. et al.; Hutten, Barbara A.; Péquériaux, Nathalie C. V.; Levi, Marcel; Sturk, 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 (Springer) 27: 207. doi:10.1007/s11239-008-0203-4.
^ Ames, D. et al.; Keogh, A.M.; Adams, J.; Harrigan, S.; Allen, N. (1996). "Prospective validation of the EBAS-DEP — A short sensitive screening instrument for depression in the physically ill elderly". European Psychiatry (Elsevier) 11 (Supplement 4): 361s. doi:10.1016/0924-9338(96)89148-6.
^ Kidwell, Chelsea S. et al.; Starkman, S; Eckstein, M; Weems, K; Saver, JL (2000). "Identifying Stroke in the Field: Prospective Validation of the Los Angeles Prehospital Stroke Screen (LAPSS)". Stroke (American Heart Association) 31 (1): 71–76. PMID 10625718. http://stroke.ahajournals.org/cgi/content/abstract/strokeaha;31/1/71. Retrieved 24 September 2008.
^ U.S. Food and Drug Administration. "Ch. 4 PROCESS VALIDATION in Medical Device Quality Systems Manual". http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122439.htm. Retrieved 2009-08-06.
^ Groupe Novasep. "Retrospective validation". http://www.novasep.com/misc/glossary.asp?defId=185&lookfor=&search=R. Retrieved 24 September 2008.
^ Validation-online.net. "Retrospective validation Rationale". http://www.validation-online.net/retrospective-validation.html. Retrieved 24 September 2008.
^ Vieth, Erich. "Who changed the Bible and why? Bart Ehrman’s startling answers". http://www.dangerousintersection.org/?p=668. Retrieved 26 September 2008.
^ Arlandson, James M.. "Domestic violence in Islam". http://www.answering-islam.org/Authors/Arlandson/beating.htm. Retrieved 17 October 2008.
^ Hart, D.; S.W. Smith (2007). "Retrospective Validation of a Clinical Decision Rule to Safely Rule Out Subarachnoid Hemorrhage in Emergency Department Headache Patients". Annals of Emergency Medicine 50 (3): S102–S103. doi:10.1016/j.annemergmed.2007.06.388.
^ Kluger, Michael D. et al.. "Retrospective Validation of a Surveillance System for Unexplained Illness and Death: New Haven County, Connecticut". http://www.ajph.org/cgi/content/abstract/91/8/1214. Retrieved 26 September 2008.
^ Fine, Leon G. et al.. "How to evaluate and improve the quality and credibility of a Tags: | |
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