Verification and validation are independent procedures used together to check that a product, service or system meets the requirements and specifications and meets its intended purpose. This is an important component of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded by "independent", indicating that verification and validation should be performed by uninterested third parties. "Independent verification and validation" can be abbreviated as " IV & amp; V ".
In practice, as a term of quality management, the definition of verification and validation may be inconsistent. Sometimes they are even used interchangeably.
However, the PMBOK guidelines, the standards adopted by the IEEE, define it as follows in its fourth edition:
- "Validation Guarantees that a product, service or system meets the needs of customers and other identified stakeholders This often involves acceptance and compliance with external customers contrast with verification ."
- "Verify Evaluate whether a product, service or system complies with rules, requirements, specifications or conditions imposed This is often an internal process Contrast with validation ."
Video Verification and validation
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Verification is intended to check whether a product, service, or system (or its part, or set) meets a set of design specifications. In the development stage, the verification procedure involves conducting a special test to model or simulate a part, or the whole, a product, a service or a system, then perform a review or analysis of modeling results. In the post-development phase, the verification procedure involves periodic repetition tests designed specifically to ensure that the product, service or system continues to meet initial design requirements, specifications and regulations over time. This is the process used to evaluate whether a product, service or system complies with the rules, specifications, or conditions imposed at the start of the development phase. Verification can be either development, upgrades, or production. This is often an internal process.
Validation is intended to ensure that the product, service, or system (or any part thereof, or organize it) produces products, services, or systems (or parts thereof, or arranges) that satisfy the user's operational needs. For new development flows or verification flows, a validation procedure may involve flow modeling and simulation use to predict errors or loopholes that may lead to invalid or incomplete verification or development of a product, service or system (or part thereof, or thereof) ). ). A set of validation requirements (as defined by the user), specifications and regulations can then be used as a basis to qualify the development flow or verification flow for the product, service, or system (or portion thereof, or organize it). Additional validation procedures also include procedures designed specifically to ensure that modifications made to qualifying development flow or flow verification will have the effect of producing a product, service, or system (or parts thereof, or arranging) that meet the initial design requirements, specifications and regulations; this validation helps keep the flow quality up. This is a process of building evidence that provides a high level of assurance that a product, service or system meets the intended requirements. This often involves receiving fitness for a 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 question "Are you building things right?" and verify with "Did you build it correctly?". "Building the right thing" refers back to the needs of the user, while "building it up properly" checks that the specification is correctly implemented by the system. In some contexts, written requirements are required both for formal procedures and protocols or protocols for determining compliance.
It is likely that a product qualifies when it is verified but fails when it is validated. This can happen when, say, a product is built to specification but the specification itself fails to meet the needs of the user.
Maps Verification and validation
Activity
Engine and equipment verification usually consists of design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). DQ may be performed by the vendor or by the user, by confirming through review and testing that the equipment meets the written acquisition specifications. If the relevant document or manual of the machine/equipment is provided by the vendor, the next 3Q should be completely done by users working in an industry regulatory environment. Otherwise, IQ, OQ and PQ processes are validation tasks. A typical example of such a case is the loss or absence of vendor documentation for legacy or do-it-yourself (DIY) equipment (eg cars, computers, etc.) and, therefore, users should attempt to obtain DQ documents first.. Each DQ, IQ, OQ and PQ template can usually be found on the internet respectively, whereas DIY qualification machines/equipment can be assisted either by course training materials and vendor tutorials, or by published manuals, such as i> step-by-step series if the acquisition of the machine/equipment is not bundled with the on-site qualification service. This type of DIY approach also applies to software qualifications, computer operating systems and manufacturing processes. The most important and important task as the last step of this activity is to generate and archive engine/equipment qualification reports for audit purposes, if regulatory compliance is mandatory.
Engine/equipment qualification depends on place, especially shock sensitive items and requires balance or calibration, and re-qualification is required after the object is relocated. The full scale of some equipment qualifications even time depends when the consumable consumables (ie filters) or springs are stretched, require re-calibration, and therefore recertification is required when a specified time interval is determined. Re-qualification of the machine/equipment should also be made when replacement parts, or connections with other devices, or installing new application software and computer restructuring that affect primarily the initial settings, such as the BIOS, the registry, the disk drive of the partition table, dynamic (shared), or this file, etc., is required. In such situations, the specification of the piece/device/software and the restructuring proposal should be added to the qualification document whether the original piece/device/software is or not. Torres and Hyman have discussed the appropriateness of non-genuine parts for clinical use and provide guidance for equipment users to choose the right replacement that can avoid side effects. In cases where the original component/device/software is requested by some regulatory requirements, then re-qualification does not need to be performed on an unauthentic assembly. Instead, assets should be recycled for non-regulatory purposes.
When the qualification of the machine/equipment is performed by a third party supported by such standards by an accredited ISO standard company for a particular division, this process is called certification. Currently, ISO/IEC 15408 certification coverage by ISO/IEC 27001 accredited organizations is limited; this scheme requires considerable effort to be popularized.
Category validation
Validation work can generally be categorized by the following functions:
- Validate candidates - missions performed before new items are released to ensure the characteristics of interests that work properly and that meet safety standards. Some examples may be legislative rules, guidelines or proposals, methods, theories/hypotheses/product models and services
- Retrospective validation - processes for items already in use and distribution or production. Validation is performed against written specifications or predetermined expectations, based on documented/recorded historical/documentary data. If any important data is missing, then the work can not be processed or can only be partially completed. Assignment is considered necessary if:
- prospective validation is missing, inadequate or defective.
- changes to legislative rules or standards affect the compliance of items released to the public or the market.
- revive unused items.
- Some examples can be validation:
- ancient scriptures that remain controversial
- clinical decision rule
- data system
- Full-scale validation
- Partial validation - often used for research and pilot studies if time is limited. The most important and significant effects are tested. From the perspective of analytical chemistry, the effect is selectivity, accuracy, repetition, linearity, and range.
- Cross validation
- Resubmit/Location Validation or Periodic - done, for interesting items that are closed, fixed, integrated/merged, moved, or after a certain time interval. Examples of these categories may include re-licensing/renewing the SIM, re-certifying an outdated or relocated analytical balance, and even re-validating the professional. Re-validation can also be made when/when changes occur during activities, such as scientific research or transition phase of clinical trials. An example of this change may occur
- sample matrix
- production scale
- profile and population size Investigate
- out-of-specification (OOS), due to test reactant contamination, glasswares, aging equipment/devices, or depreciation of related assets etc.
- In GLP-accredited laboratories, verification/revalidation will even be done very often to monographs from Ph.Eur., IP to meet multinational or USP and BP needs to meet national needs. These laboratories must have validation methods as well.
- Co-validation - performed during routine processing of services, manufacturing or engineering, etc. This example can be
- sample analysis duplicated for chemical test
- triplicated sample analysis to track impurities at marginal level of detection margins, or/and quantification limits
- Single sample analysis for chemical tests by skilled operators with online conformity system testing
Validation aspect
The most commonly tested attributes in a validation task may include, but are not limited to
- Selectivity/specificity
- Accuracy and precision
- Repeat
- Reproducibility
- Detection limits - especially for trace elements
- Quantification limit
- Pas curve and range
- System compatibility - In general, this typically includes rudeness tests among intercolaborators, or endurance tests within an organization. However, the US Food and Drug Administration (FDA) specifically defines it for administration, as "System suitability testing is an integral part of many analytical procedures.Testing is based on the concept that equipment, electronics, analytical operations and samples to be analyzed are integral systems that can be evaluated as such: The system suitability testing parameters to be specified for a particular procedure depends on the type of validated procedure ". In some cases of analytical chemistry, the system suitability test can be more specific than the universal method. The examples are chromatographic analysis, which is usually sensitive media (column, paper or cellular solvent). However, to date of this writing, such an approach is limited to several pharmaceutical compendium methods, by which detecting dirt, or the quality of the intest being analyzed is essential (ie, life and death). This is probably mostly due to
-
- the demands of intensive work and the consumption of their time
- their confinement by definition of terms defined by different standards.
- To overcome such difficulties, some regulatory bodies or compendial methods usually provide suggestions as to what circumstances or conditions should be performed by the specified and compulsory system specification testing suitability.
Industry reference
These terms generally apply widely throughout industry and institutions. In addition, they may have very specific meaning and requirements for specific products, regulations, and industries. Some examples:
- Software and computer systems
- Food and Drugs
- Pharmaceutical The design, production, and distribution of drugs is highly regulated. This includes software systems. For example, in the United States, the Food and Drug Administration has regulations in Section 21 of the Federal Code Rules. Nash et al. has published a book that provides comprehensive coverage on various validation topics of pharmaceutical manufacturing processes. Some companies take a risk-based approach to validate their GAMP system if one understands the regulatory requirements very well while most others follow the conventional process This is part of GxP management. The validation and verification aspects are even more intense and emphasized if OOS happens. Very often under these circumstances, multiple sample analysis is required to conduct OOS investigations in the testing laboratory.
- FDA medical equipment (21 CFR) has validation and verification requirements for medical equipment. See the guide: and ISO 13485
- The cleaning and validation process of cleaning is required and regulated by the US Food and Drug Administration
- Food hygiene: example
- Clinical laboratory medicine: ISO 15198: 2004 Clinical laboratory medicine - In vitro diagnostic medical device - Validation of user quality control procedures by manufacturer
- Health care: example
- Greenhouse gases: ISO 14064 ANSI/ISO: Greenhouse gases - Requirements for validation of greenhouse gases and verification bodies for use in accreditation or other forms of acknowledgment
- Traffic and transportation
- Road safety audit
- Periodic motor inspections
- Airplane sound: example
- Planes: [2]
- Model: [3] Cell
- (Ni-Cd): example
- The ICT industry: example
- Civil engineering
- Buildings -
- Road -
- Bridge -
- Economy
- Accounting
- Agriculture - applications vary from verifying agricultural methodology and production processes to validating agricultural modeling
- Real estate appraisal - auditing reporting and authentication
See also
Notes and references
Further reading
Majcen, N.; Taylor, P. (2010). "Practical examples of traceability, measurement uncertainty and validation in chemistry". 1 . EU: 217. ISBN: 978-92-79-12021-3.
External links
- Maturity verification and validation at ICT company
- Organizational maturity and functional performance
Source of the article : Wikipedia
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