What does the word validation mean. Validation is in simple terms. Hello dear readers! Welcome to the blog

Hello dear readers! Welcome to the blog!

Validation - what is it in simple words? What is the difference between validation and verification? The answers to these questions are in the article.

Many words "validation" and "verification" are considered synonymous. But this is not the case. There is a difference, but it is very subtle. Let's figure it out.

Validation and verification - what is it in simple words?

For the sake of fairness, I must say that in different areas of activity (in banks, in payment systems, on the Internet), in different industries, these terms are used in different ways. I decided to bring here definition of validation and verification from ISO 9000 standard.

We see that the definitions coincide in a significant part, but not completely. However, despite such a great coincidence validation and verification are different actions.

To make it easier to understand what validation is, let's first figure out how validation differs from verification.

Quite often, when it comes to the standards of performance and conformity of products to the requirements established in the documentation, the concept of validation is encountered. To the uninitiated in the intricacies of the matter, the reader may not be completely clear, but what does it mean. The situation is complicated by the fact that the words "validation" and "verification" are often confused with each other. These concepts are increasingly flashing on various sites during registration or purchase payment. Therefore, it is very important to separate the wheat from the chaff and understand what both of these terms mean and in what cases each of them should be used.

In general, the translation of English technical terms and their use in Russian are accompanied by conceptual difficulties. The terms "validation" and "verification" appeared in the Russian technical language with the emergence of the technological standard ISO 9000. Based on this document, some time later its Russian counterpart, GOST R ISO 9000-2008, was developed. Both of these documents regulate terminological use and indicate the basic concepts of the technical dictionary. Including there you can find an explanation of the meaning of the terms of interest to us.

What is validation and how it differs from verification

In simple terms, validation is a check of a product to see if it meets the stated characteristics. That is, any mobile phone will not pass validation until customers make sure that it has exactly the camera and the exact amount of memory for which they were willing to pay.

Verification is precisely the process that precedes product validation. That is, when the customer of the phone from the previous example checked it for compliance with the stated requirements, then he verified mobile phone... At the same time, the product verification process usually includes an analysis of the product: are all the necessary parts in place, are they working correctly, and so on.

And now again, but in comparison. Validation is an analysis of a product for its performance (whether the phone turns on and can it ring). Verification is a bureaucratic option, that is, during this process, testers check whether the component parts of the product meet the established technical manufacturing standards.

Perhaps standardization professionals will say that this is too crude and incomplete explanation, but it gives a general picture of what these words are so incomprehensible.

Let's give one more example. Let's imagine that a new drink is planned to enter the market. The manufacturing method and the required standards are sent to the factory. At the end of the production process, the manufacturer checks (verifies) the composition of the drink and its compliance with the declared standard. The customer of a batch of drinks conducts a series of tests on how much the drink is liked by potential customers in terms of taste. If no problems arise at this stage of the verification, then the drink can be considered valid.

That is, during the validation process, it is checked whether the manufactured product has the result that manufacturers and developers expected during its design. It happens that the product goes through the verification process, but in fact it turns out that it does not work. Thus, a validated product is more credible.

Using validation and verification in online services

Often, when registering on sites that do not want to produce fake pages, new users need to go through a verification process. It consists in receiving an SMS notification or letter to email with a code that you will then need to enter in order to confirm that you are in fact a real person, and not a bot.

Various payment systems also put forward such requirements to their users.

Most often, new users do not have access to the full functionality until they send their passport data and confirm their phone number. After confirming the reality of your identity, your account is considered valid and now you can use the services of the site to the fullest.

In this case, if we use the method of selection of synonyms, then the first version of verification is verification, but validation is confirmation, attestation.

I would like to believe that this article gave you a rough understanding of what such a beast as validation is, and how it differs from its verification cousin. Do not confuse these two terms, because the purity and correctness of your language is the key to understanding words by other people.

ISO 9000: 2000 defines these terms as follows:

« Verification - confirmation, based on the provision of objective evidence, that the specified requirements have been met. "

« Validation - confirmation, based on the provision of objective evidence, that the requirements for a particular use or application have been met. "

It would seem that the definitions almost coincide, and if not completely, then in a significant part. And, nevertheless, verification and validation are fundamentally different actions.

Let's figure it out.

Already the translation of these terms from English provides some food for understanding the difference: verification - verification, validation - legalization.

To make it easier to understand, I will immediately give an example of a typical verification: testing a program or testing equipment. With certain requirements in hand, we test the product and record whether the requirements are met. The result of verification is the answer to the question "Does the product meet the requirements?"

But it is far from always that a product that meets the established requirements can be applied in a specific situation. For example, a medicine passed all the required tests and went on sale. Does this mean that it can be applied to some specific patient? No, because each patient has its own characteristics and specifically for this, the medicine can be destructive, i.e. someone (the doctor) must confirm: yes, this patient can take this medicine. That is, the physician must perform validation: to give legal effect to a specific application.

Or another example. The enterprise produces pipes intended for burial in accordance with some TU (Technical Specifications). The products comply with these TUs, but an order has been received for pipe laying on the seabed. Can pipes corresponding to the existing specifications be used in this case? It is validation that gives the answer to this question.

It is easy to see that another difference is that verification is always performed, but there may be no need for validation. It appears only when requirements arise related to a specific application of the product. If a pharmaceutical plant produces drugs, then it will only check their compliance with the requirements, and will not deal with the problems of using specific drugs by specific patients. Or the same AvtoVAZ.

Thus, we can state the following:

verification - carried out almost always, performed by the method of checking (comparing) the characteristics of products with the specified requirements, the result is a conclusion about the conformity (or nonconformity) of the product,

validation - carried out if necessary, performed by analyzing the specified conditions of use and assessing the compliance of product characteristics with these requirements, the result is a conclusion about the possibility of using the product for specific conditions.

ISO 9001: 2000 refers to these terms in two places.

Let's check if the interpretation I have given is consistent with the content of Sections 7.3.5, 7.3.6 and 7.5.2.

"7.3.5. Project and development verification. Verification should be carried out in accordance with the planned arrangements (clause 7.3.1) to ensure that the design and development outputs meet the input requirements ... ".

"7.3.6. Project and development validation. Design and development validation should be carried out in accordance with planned arrangements (clause 7.3.1) to ensure that the resulting product meets the requirements for the specified or intended use, if known. Where practicable, validation should be completed prior to product delivery or use ... ”.

It is easy to see that my interpretation is in complete agreement with the text of these sections. At the same time, I would like to draw your attention to the fact that in cl.

Testing, Verification and Validation - Concept Differences

7.3.5 refers to the conformity of the output, and clause 7.3.6 refers to the product. This is essential! This means that validation is not performed for output data, but for products designed for specific conditions. For example, in the activities of the institute for the development of standard projects of residential buildings, validation is not required - only verification. But for the activity on the development of a project for the construction of a residential building according to the same standard project, but in a specific place, validation is already necessary.

"7.5.2. Validation of production and service processes. The organization shall confirm all production and service processes whose results cannot be verified through consistent monitoring or measurement. These include all processes whose deficiencies become apparent only after the product has been used or after the service has been provided. Validation should demonstrate the ability of these processes to achieve planned results ... ”.

There is also no discrepancy here. But it should be noted that in cases falling under clause 7.5.2 product characteristics cannot be measured directly and will be evaluated indirectly (for more details, see the lecture on special processes).

Question: what is the activity of the Quality Control Department?

Answer: this is verification.

Question: what should be attributed to the activities of auditors?

Answer: to verification.

Question: what function does the signing act on the commissioning of an object (services, etc.) perform?

Answer: it does validation.

What is production validation and verification

What is verification and validation in simple words

Verification and validation: definition from Wikipedia

In various spheres of human activity, verification (from Lat. Verus - "true" and facere - "to do") can mean different concepts, for example:
verification, verifiability, a method of confirming with the help of evidence any theoretical provisions, algorithms, programs and procedures by comparing them with experimental (reference or empirical) data, algorithms and programs. The principle of verification was put forward by the Vienna Circle;
confirmation of compliance of the final product with predefined reference requirements;
a technique for recognizing lies (concealment, distortion).
In the meaning of provability, verifiability of explanations (models) of objects / phenomena, depending on the degree of confirmation by reality (empirically, facts), forms the concepts:
A hypothesis is an unproven falsified plausible statement based on a number of observations or judgments, concepts, postulates (in science) that confirm it.

What is the difference between validation and verification

Hypotheses based on false judgments, wrong concepts, postulates constitute pseudoscience.
A concept is a model with and / or without facts confirming its truth (see Philosophy).
Theory is an explanation with the provision of evidence of the maximum degree (see Science).
The root of the different understanding of the concept of verification lies in the spectrum of possibilities for comparing the conformity of the final product to predefined requirements. It is possible to verify the conformity of the final product to the predetermined requirements, depending on the situation, by direct and indirect characteristics of this final product. And also there process approachthat tracks the progress of the product towards predefined requirements.

The current page defines the word verification and validation. simple language... We hope that after reading this explanation in simple words, you no longer have any questions about what verification and validation are.

Content

In the spoken language, new terms often appear, the sound of which may seem unfamiliar and meaningless to the opponent. It is not very convenient to ask the interlocutor again, and I would not like to demonstrate my incompetence in public either. Therefore, it is recommended to learn new words of colloquial speech, to find out their meaning.

What is validation

This is one of the thematic terms that is difficult for a simple layman to explain, it is even more difficult to understand the exact definition in scientific language. Primary sources provide a difficult interpretation, so it is better to use simple, accessible examples from life. So, there is a concept of validation - what is it in simple words? After examining the scientific explanation, we can conclude. This unfamiliar word in its meaning is close to such a concept as certification, denotes a global verification of a product according to all parameters set initially by the customer.

For example, if we are talking about a mountain bike, this vehicle is considered validated if the customer rode it and was satisfied with the speed, quality of the work performed, functions, design and other parameters initially specified by the project. Simply put, this is control testing so that the user is personally convinced of the result, a truly profitable purchase.

Validation in civil law

This word can mean the legal force of a particular document, it is often found in civil law. In simple terms, this is legalization, acceptance as a norm, approval. For example, upon the expiration of the specified period, a document enters into legal force, becomes valid in the legal field, jurisprudence. Thus, the validation confirms the final decision of the judge, and the appeal is no longer possible.

Validation in systems programming

In this area, the meaning of the word is associated with the receipt, processing, verification and transmission of data. Validation is relevant for any user of the account, since it confirms and officially proves the correctness of the actions. To understand what this word means in an accessible language, you can give good example about customer satisfaction:

  • A copywriter sells his articles.
  • Before the sale, he checks the data for errors and plagiarism using various systems online.
  • If, according to the results, the article turns out to be unique, and the spelling meets the requirements of the Russian language, the publication is valid. The verification service account itself is referred to as a validator.

Manufacturing process validation

Thinking about the pharmaceutical industry or industry, it is easy to see that the word validation means that the product meets all the requirements of the manufacturer, so as not to undermine his impeccable reputation in the market for services and goods. Simply put, the company is responsible for high quality and the correctness of the manufacture of products that must meet the declared standards:

  • For example, the release of a car takes place after checking all components, in accordance with international requirements.
  • The validator confirms the declared specifications, personal data, and the passed testing makes the auto valid.
  • The buyer, carrier or intermediary, in the event of a mismatch in the parameters, can make a claim to the validator. Then additional testing of the product is carried out in production.

How verification and validation differ

In simple terms, both terms have a similar meaning, are synonymous. On this topic, there are many simple examples, but there is still a significant difference. If the validation is complex check goods, then verification focuses more on adherence to the technological process, consistent performance of all stages of production. When the finished product does not satisfy a person in terms of quality parameters, the word verification does not matter to the stated claim.

ISO 9000: 2000 defines these terms as follows:

« Verification - confirmation, based on the provision of objective evidence, that the specified requirements have been met. "

« Validation - confirmation, based on the provision of objective evidence, that the requirements for a particular use or application have been met. "

It would seem that the definitions almost coincide, and if not completely, then in a significant part. And, nevertheless, verification and validation are fundamentally different actions.

Let's figure it out.

Already the translation of these terms from English provides some food for understanding the difference: verification - verification, validation - legalization.

To make it easier to understand, I will immediately give an example of a typical verification: testing a program or testing equipment. With certain requirements in hand, we test the product and record whether the requirements are met. The result of verification is the answer to the question "Does the product meet the requirements?"

But it is far from always that a product that meets the established requirements can be applied in a specific situation. For example, a medicine passed all the required tests and went on sale. Does this mean that it can be applied to some specific patient? No, because each patient has its own characteristics and specifically for this, the medicine can be destructive, i.e. someone (the doctor) must confirm: yes, this patient can take this medicine. That is, the physician must perform validation: to give legal effect to a specific application.

Or another example. The enterprise produces pipes intended for burial in accordance with some TU (Technical Specifications). The products comply with these TUs, but an order has been received for pipe laying on the seabed. Can pipes corresponding to the existing specifications be used in this case? It is validation that gives the answer to this question.

It is easy to see that another difference is that verification is always performed, but there may be no need for validation. It appears only when requirements arise related to a specific application of the product. If a pharmaceutical plant produces drugs, then it will only check their compliance with the requirements, and will not deal with the problems of using specific drugs by specific patients. Or the same AvtoVAZ.

Thus, we can state the following:

verification - carried out almost always, performed by the method of checking (comparing) the characteristics of products with the specified requirements, the result is a conclusion about the conformity (or nonconformity) of the product,

validation - carried out if necessary, performed by analyzing the specified conditions of use and assessing the compliance of product characteristics with these requirements, the result is a conclusion about the possibility of using the product for specific conditions.

ISO 9001: 2000 refers to these terms in two places. Check if the interpretation I have given is consistent with the content of Sections 7.3.5, 7.3.6 and 7.5.2 .

"7.3.5. Project and development verification. Verification should be carried out in accordance with the planned arrangements (clause 7.3.1) to ensure that the design and development outputs meet the input requirements ... ".

« 7.3.6. Project and development validation. Design and development validation should be carried out in accordance with planned arrangements (clause 7.3.1) to ensure that the resulting product meets the requirements for the specified or intended use, if known. Where practicable, validation should be completed prior to product delivery or use ... ”.

It is easy to see that my interpretation is in complete agreement with the text of these sections. At the same time, I would like to draw your attention to the fact that clause 7.3.5 refers to the conformity of the output data, and clause 7.3.6 - to products. This is essential! This means that validation is not performed for output data, but for products designed for specific conditions. For example, in the activities of the institute for the development of standard projects of residential buildings, validation is not required - only verification. But for the activity on the development of a project for the construction of a residential building according to the same standard project, but in a specific place, validation is already necessary.

"7.5.2. Validation of production and service processes. The organization shall confirm all production and service processes whose results cannot be verified through consistent monitoring or measurement. These include all processes whose deficiencies become apparent only after the product has been used or after the service has been provided. Validation should demonstrate the ability of these processes to achieve planned results ... ”.

There is also no discrepancy here. But it should be noted that in cases falling under clause 7.5.2 product characteristics cannot be measured directly and will be evaluated indirectly (for more details, see the lecture on special processes).

The question is: what is the activity of the Quality Control Department?

Answer: this is verification.

Question: what should be attributed to the activities of auditors?

Answer: to verification.

Question: What is the function of the signing act on the commissioning of the facility (services, etc.)?

Answer: it does validation.

The concept of "validation" is used in various fields of human activity. The main point of validation is to reconcile the stated requirements that are required to achieve the stated goal.

Basic meanings of the term "validation"

Two terms should not be confused - "validation" and "verification", there is a significant difference between them. What is validation? In simple words, we can say this: it is the process of bringing objective evidence that the requirements of a certain external consumer or user of a service / product / system are fully satisfied.

When do you need to validate?

According to the international quality standard ISO 9001, the company is obliged to carry out certification of all activities of the implementation of production and services, if the final product cannot be checked by monitoring or subsequent measurement, and, as a result, deficiencies can only be identified after the provision of the service or the use of the product. It follows that for all actions of obtaining products that are carried out outside the walls of production, it is necessary to carry out validation.

What does validation mean? The procedure involves a set of measures that are aimed at proving that all systems, algorithms, equipment, materials used, etc. lead to the desired results. If, during validation or on the basis of the results, the indicators receive a bad score, all used resources are written off as losses automatically.

Equipment validation

During the production of equipment, all manufacturers indicate the conditioned properties of the product. These include:

  • Terms of Use.
  • Weight.
  • Dimensions.
  • Power supply parameters and so on.

Typically, users are primarily interested in: performance range, reliability, and stability. It is the last two indicators that are studied during the audit. Validation - what is it in simple words? Indications:

  • For equipment that was installed for the first time, it is necessary to carry out validation, it is also recommended to do this after any movement.
  • The frequency of validation repetitions determines the stability of the equipment performance.
  • The frequency of equipment validation and analysis of the results are discussed with the customer. In some cases, equipment inspection must be carried out on the eve of launch or after a long downtime.

Process validation

Manufacturing validation involves justifying that the process will lead to specified results. Verification should be carried out when starting a new production process or when making amendments. The conditions for secondary validation after changes are made are negotiated with the customer or established based on the internal requirements of the enterprise.

For certain types of production, process validation is required at each line start-up or after a long downtime. In this case, a simplified validation plan is applied, but the assessment is more rigorous.

Product validation

Product validation differs from other types in that it takes into account (but does not replace) the entire production chain, including equipment and process verification. The purpose of the audit is to certify that all procedures and processes carried out will lead to the production of the required product. Product validation is a complex of studies:

  • Numerical indicators.
  • Qualitative indicators.

The check is carried out at the initial stage of production and is repeated when any amendments are made to the product configuration.

Validation in the quality management system in accordance with ISO 9000 samples

Validation is confirmation based on the provision of evidence that the requirements for a specific application or use have been fulfilled (ISO 9000: 2005). There is a procedure for confirmation by means of examination and provision of objective information.

Validation stages:

  • In development and design, an approval denotes that an examination of the product has been carried out to determine whether it meets the needs of the consumer.
  • The approval process is usually carried out on the final product and under specified operating conditions. In some cases, validation occurs early in production.
  • The term “approved” is used to indicate the respective status. When the product is used in many ways, the approval is repeated several times (ISO 8402: 1994, clause 2.18).

Differences between validation and verification

Verification is usually an internal process of regulating the quality of a product, which takes place in accordance with instructions, samples and specifications. What's the difference between validation and verification?

  • Validation is confirmation that you have produced the correct product.
  • Verification - confirmation that the product turned out the way you wanted to produce it.

An example of standard verification is performing equipment testing.

  • Receipt / confirmation of requirements and norms for a product.
  • Implementation of tests.
  • Fixing the results, checking for compliance with the requirements.
  • Verification results.

Even if the product fully meets the requirements, it is not always possible to use it in a specific situation.

Examples of

For example, a medical product passed all the necessary checks and went into sale. Does this mean that any patient can take it? No, since any patient has the characteristics of the organism, and directly in his situation, the drug can be harmful, therefore the patient should consult with the attending doctor, who, in turn, must testify: yes, the use of this drug is indicated for this patient. Here is the answer to the question: what is validation? In simple words, this is a verification of the product for its applicability in a given situation, that is, the doctor performs the validation process.

Another example: the company is engaged in the production of pipes for laying in the ground according to TU ( technical specifications). The product fully meets the requirements, but an order has been placed for laying pipes on the seabed. In this case, can pipes intended to be laid in the ground be used for laying under water? It is the validation that will answer the question.

Another difference between these processes is that verification is always performed, but there may be no need for validation. Validation - what is it in simple words, what are the indications for its implementation?

The need arises only in cases where requirements are formed associated with a specific use of the product. If a pharmaceutical factory produces drugs, it only checks for compliance with the established requirements, and will not deal with the use of certain drugs by patients.

Hence the following can be distinguished:

  • Verification is an ongoing process, and it is performed by checking the characteristics of the product with the requirements set, as a result, a decision is made on compliance / non-compliance with these requirements.
  • Validation is done on demand and is performed through research established conditions use and assessment of the conformity of product characteristics to these conditions, as a result, a decision is made on the use of the product in a particular situation.

Summing up, let's answer the question: what is validation? In simple words, this is confirmation, which is created on the basis of objective evidence that the conditions for a specific use or application have been met with accuracy and in full, which means that the goal has been achieved.