Validation, verification, special process. Validation - what is it in simple words

The two concepts of validation and verification are often confused. In addition, system requirements validation is often confused with system validation. I suggest looking into this issue.

In the article, I considered two approaches to object modeling: as a whole and as a structure. In the current article, we will need this division.

Suppose we have a designed functional object. Let this object be considered by us as a part of the construction of another functional Object. Let there be a description of the construction of the Object, such that it contains a description of the object. In such a description, the object has a description as a whole, that is, its interfaces of interaction with other objects are described within the framework of the Object's construction. Let the description of the object as a structure be given. Let there be an information object containing requirements for the design of the description of the object as a structure. Let there be a body of knowledge that contains inference rules, on the basis of which a description of the object as a structure is obtained from the description of the object as a whole. The body of knowledge is what designers are taught in institutes - a lot, a lot of knowledge. They allow, on the basis of knowledge about the object, to design its structure.

So, you can start. We can assert that if the object as a whole is correctly described, if the body of knowledge is correct, and if the rules of inference were observed, then the resulting description of the object's construction will be correct. That is, on the basis of this description, a functional object corresponding to the actual operating conditions will be built. What risks may arise:

1. Use of incorrect knowledge about the Object. The model of the Object in people's minds may not correspond to reality. They did not know the real danger of earthquakes, for example. Accordingly, the requirements for the object may be incorrectly formulated.

2. Incomplete record of knowledge about the Object - something is missed, mistakes are made. For example, they knew about the winds, but forgot to mention it. This may lead to insufficient full description object requirements.

3. Wrong body of knowledge. We were taught the priority of mass over other parameters, but it turned out that we had to increase speed.

4. Incorrect application of inference rules to the object description. Logical errors, something is missing in the requirements for the object design, the requirements trace is broken.

5. Incomplete record of the obtained conclusions about the design of the system. Everything was taken into account, everything was calculated, but they forgot to write.

6. The created system does not match the description.

It is clear that all project artifacts appear, as a rule, in their completed form only by the end of the project, and even then not always. But, if we assume that the development is waterfall, then the risks are as I described. Checking each risk is a specific operation that can be given a name. If anyone is interested, you can try to come up with and voice these terms.

What is verification? In Russian, verification is a check for compliance with the rules. The rules are in the form of a document. That is, there should be a document with documentation requirements. If the documentation meets the requirements of this document, then it has passed verification.

What is validation? In Russian, validation is the verification of the correctness of the conclusions. That is, there should be a body of knowledge that describes how to get a description of a design based on object data. Checking the correctness of the application of these conclusions is validation. Validation is, among other things, checking the description for consistency, completeness, and comprehensibility.

Requirements validation is often confused with the validation of a product built on those requirements. It's not worth doing that.

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

Basic meanings of the term "validation"

Two terms - "validation" and "verification" should not be confused with each other, there is a significant difference between them. Validation - what is it? In simple words, this 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 is validation required?

According to international standard ISO 9001 quality standards, the enterprise is obliged to certify all activities of production and services, if the final product cannot be verified by monitoring or subsequent measurement, and, as a result, defects can be identified only after the provision of the service or the application of the product. It follows that for all actions of obtaining products that are carried out outside the walls of the 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 required results. If during the validation or following the results the indicators get a bad rating, all the resources used are written off as losses automatically.

Equipment validation

In the production of equipment, all manufacturers indicate the conditional properties of the product. These include:

• Terms of Use.
• Weight.
• Dimensions.
• Power supply settings and more.

As a rule, 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 terms? Indications:

• For equipment that was first installed, it is necessary to carry out validation, it is also recommended to do this after any movement.
• The frequency of validation repetitions determines the performance stability of the equipment.
• The frequency of equipment validation and analysis of the results are negotiated with the customer. IN individual cases Checking the equipment should be carried out on the eve of start-up or after a long downtime.

Process Validation

Production validation involves justifying that a process will produce specified results. Checking should be done when starting a new production process or when amending. The conditions for secondary validation after making changes are negotiated with the customer or established based on the internal requirements of the enterprise.

For certain types In production, process validation is required every time a line is started up or after a long downtime. In this case, a simplified validation plan is applied, but the evaluation is more thorough.

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 verification 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 on initial stage 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 requirements are met that are intended for a particular application or use (ISO 9000:2005). There is a confirmation procedure by the method of conducting an examination and providing objective information.

Validation steps:

• In development and design, approval means that an examination of the product has been carried out to establish compliance with 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 is carried out at an early stage of production.
• The term "approved" is used to indicate the respective status. With a variety of product applications, approval occurs multiple times (ISO 8402:1994, clause 2.18).

Differences between validation and verification

Verification is usually internal process regulating the quality of a product that occurs in accordance with instructions, samples and specifications. What is the difference between validation and verification?

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

An example of a standard verification is performing a hardware test.

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

Even if the product is fully compliant, it may not always be possible to use it in a particular situation.

Examples

For example, a medical product has passed all the necessary checks and entered the market. Does this mean that any patient can take it? No, since any patient has the characteristics of the body, and directly in his situation, the drug can be harmful, so 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: validation - what is it? In simple words, this is a test of the product for the possibility of using it in a given situation, that is, the doctor performs the validation process.

Another example: an enterprise is engaged in the production of pipes for laying in the ground according to the specifications (technical specifications). The product fully complies with the requirements, but an order has been placed for laying pipes on the seabed. IN this case Can pipes intended for underground installation be used for underwater installation? It is the validation that will answer the question.

Another difference between these processes is that verification is always carried out, 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 those cases when requirements are formed associated with a certain use of the product. If a pharmaceutical factory manufactures medicines, it only performs compliance testing, and will not deal with the use of certain medicines by patients.

From this we can distinguish the following:

• Verification is a continuous process, and it is performed by comparing the product characteristics with the set requirements, as a result, a decision is made on compliance / non-compliance with these requirements.
• Validation is carried out on demand and is performed by examining the established conditions of use and evaluating the compliance of product characteristics with 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: validation - what is it? In simple words, this is a confirmation that is created on the basis of objective evidence that the conditions for a particular use or application are met with accuracy and in full, which means that the goal has been achieved.

— legalization, approval, legalization, ratification
(common civil law);

- a process that allows you to determine how accurately, from the perspective of a potential user, a certain model represents given entities real world
(system Programming);

- a procedure that a high degree confidence that a particular process, method or system will consistently produce results that meet predetermined acceptance criteria; in particular, the validation of technological processes is carried out using samples of at least three batches of a real product in order to prove and provide documentary evidence that the process (within the established parameters) is repeatable and leads to the expected results in the production of an intermediate or finished product of the required quality; validation of analytical methods consists in determining: accuracy, reproducibility, sensitivity, stability (interlaboratory reproducibility), linearity and other metrological characteristics
(GMP - Good Manufacturing Practice, is a mandatory requirement in the manufacture of medicines).

In relation to quality management systems according to ISO 9000 series standards:

Validation— confirmation, based on the presentation of objective evidence, that the requirements for a particular use or application are met
(ISO 9000:2005)

Validation— confirmation by examination and provision of objective evidence that the specific requirements for a particular application are met.
Notes:

1. In design and development, approval means the examination of a product to determine whether it meets the needs of the customer.
2. Approval is usually carried out on end products under specific operating conditions. It may be necessary at an earlier stage.
3. The term "approved" is used to indicate the corresponding status.
4. Multiple assertions may be made if different uses are intended.

(ISO 8402:1994, clause 2.18)

As defined by PIC/S, these are:
"Actions that, in accordance with the principles of GMP, prove that a certain technique, process, equipment, raw material, activity or system actually leads to the expected results."

Validation

Validation studies should contribute to good manufacturing practice; they should be carried out in accordance with established procedures. The results and conclusions must be documented in protocols.

If a new production recipe is introduced or new way production, steps must be taken to demonstrate their suitability for mass production. It must be proven that the established process, using the specified substances and equipment, consistently produces products of the required quality.

Significant changes to the manufacturing process, including any change to equipment or materials that could affect product quality and/or process reproducibility, should be validated.

Processes and procedures should be subject to periodic critical revalidation to ensure that they continue to deliver the expected results.

Validation and its documentation

The purpose of validation is simple: to prove that the object of validation actually leads to the expected results. In other words, validation must show that the manufacturer is in complete control of the production process. Validation is an integral part of "quality assurance", showing that the manufacturer understands the reasons for process variability and, above all, understands what parameters need to be controlled to ensure process stability. Effective validation is based on risk management and modern level Sciences.

The procedures for the validation process should be recorded in a series of protocols and the results of the validation should be recorded in records or reports.

These documents are used in various forms for marketing authorization and inspection in accordance with GMP rules, and also for internal production purposes, so that the management of the organization can be sure that they control their processes. Documentation of the validation process is the basis for the necessary regulation. But in order to avoid
of the mistake that is often encountered in the implementation of GMP principles in Russia, we deliberately discuss the process of documenting validation in the section on documentation.

There is a rather serious difference between Russian and international approaches. IN Russian rules GMP, validation "consists in a documented confirmation of the compliance of the equipment, production conditions, quality of raw materials and the finished product with the current regulations and / or the requirements of regulatory documentation." This approach is outdated. Its consequences are quite harmful. From various publications, one might get the impression that the validation process is nothing more than a documenting process, or that words such as “validation”, “verification”, “qualification” and “test” are, in fact, analogues of each other. Lack of understanding of "validation" reinforces the misunderstanding of GMP, and creates a situation where staff resist the implementation of GMP, simply accepting it as "an ever-growing mountain of documents."

In EC GMP (and, by the way, FDA GMP) validation is a regular examination of systems, processes, engineering systems and, of course, the pharmaceutical product itself, in order to ensure high level confidence that the processes have been properly designed and are under control.

Effective validation requires a risk-based approach, a full understanding of production processes and increasing their sustainability through the introduction of new technologies. Thus, validation is a dynamic process. This fact obviously presents some difficulties for the regulatory authorities.

From the point of view of drug developers and manufacturers, validation can provide the following benefits:

• a deeper understanding of the processes and therefore, a reduction in risk while preventing problems and ensuring smooth process control;
• reducing the cost of eliminating deficiencies;
• reducing the risk of non-compliance with regulatory requirements.

After a full process validation, it is possible that the amount controlled parameters decrease at the end of the process. Developers, by fully understanding the parameters that affect the variability and therefore the stability of the process, have the necessary information to control the process, for example, by reducing variability or increasing its speed. Although "validation" is an integral part of "quality assurance", there is a relationship between validation and the management system. In order to effectively conduct validation, company management must define its policy in this issue. One of the first elements that an FDA or PIC/S inspector wants to check is the validation policy.

ISO 9000:2000 defines these terms as follows:

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

« Validation— confirmation, based on the presentation of objective evidence, that the requirements for a particular use or application are met.”

It would seem that the definitions almost coincide, and if not completely, then to a large extent. And yet, verification and validation are fundamentally different activities.

Let's figure it out.

Already the translation from English of these terms 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 not always a product that meets the established requirements can be used in a particular situation. For example, the drug has 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 his own characteristics, and specifically for this, the medicine can be fatal, i.e. someone (physician) must confirm: yes, this patient can take this medicine. That is, the doctor must perform validation: to validate a specific application.

Or another example. The enterprise produces pipes intended for laying in the ground, in accordance with some specifications ( Specifications). Products comply with these specifications, but an order has been received, involving the laying of pipes along the seabed. Can pipes that comply with the existing specifications be used in this case? Validation is 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 there are requirements associated with a particular 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 the use of specific drugs by specific patients. Or the same AvtoVAZ.

Thus, the following can be stated:

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

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 products for specific conditions.

ISO 9001:2000 refers to these terms in two places. Let's check whether the interpretation given by me corresponds to the content of sections 7.3.5, 7.3.6 and 7.5.2 .

"7.3.5. Verification of the design and development. Verification shall be carried out in accordance with the planned activities (clause 7.3.1) to ensure that the design and development outputs meet the input requirements…”.

« 7.3.6. Design and development validation. Design and development validation shall 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 delivery or use of the product…”.

It is easy to see that my interpretation is in full agreement with the text of these sections. At the same time, I would like to draw attention to the fact that paragraph 7.3.5 refers to the conformity of the output data, and paragraph 7.3.6 - products. This is essential! This means that the validation is not carried out for output data, but for products developed for specific conditions. For example, in the activities of the institute for the development of standard projects for residential buildings, validation is not required - only verification. But for the activity of developing 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 validate 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 start of use of the product or after the provision of the service. Validation should demonstrate the ability of these processes to achieve planned results…”.

There are no differences here either. But at the same time, it should be noted that in cases falling under clause 7.5.2, product characteristics cannot be measured directly and their assessment will be carried out indirectly (for more details, see the lecture on special processes).

Question: what is the activity of the OTK?

Answer: This is verification.

Question: what is the activity of auditors?

Answer: for verification.

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

Answer: it performs validation.

1. ISO Validation

2. What is different validation from verification?

3. Validation documents

4. XML and XHTML Validation

5. GMP validation

6. What is EITI Validation?

Validation- This legalization, approval, legalization, ratification (general civil law);

Validation- This, which allows you to determine how accurately, from the standpoint of a potential user, a certain model represents the given entities of the real world (system programming);

Validation- This a procedure that gives a high degree of confidence that a particular process the method or system will consistently produce results that meet predetermined acceptance criteria; in particular, the validation of technological processes is carried out using samples of at least three batches of real goods in order to prove and provide documentary evidence that process(within the established parameters) is repeatable and leads to the expected results in the production of intermediate or finished goods the required quality; validation of analytical methods consists in determining: accuracy, reproducibility, sensitivity, stability (interlaboratory reproducibility), linearity and other metrological characteristics

Validation ISO

In relation to quality management systems according to ISO 9000 series standards:

Validation - confirmation, based on the presentation of objective evidence, that the requirements for a particular use or application are met (ISO 9000:2005)

Validation is the confirmation by examination and the provision of objective evidence that the specific requirements for a particular application are met.

Notes:

1. In design and development, approval means the examination of a product to determine whether it meets the needs of the purchaser.

2. Approval is usually carried out on end products under certain operating conditions. It may be necessary at an earlier stage.

3. The term "approved" is used to indicate the corresponding status.

4. Multiple approvals may be made if different uses are intended. (ISO 8402:1994, clause 2.18)

Analysis of ISO 9001 requirements:

ISO 9001 clause 7.3.6: Design and development validation shall be carried out in accordance with planned activities to ensure that the resulting product meets the requirements for the specified or intended use.

ISO 9001, clause 7.5.2: Validation of production and service processes. must validate all production and service processes, the results of which cannot be verified through consistent monitoring or measurement. These include all processes whose deficiencies become apparent only after the start of use of the product or after the provision of the service. Validation should demonstrate the ability of these processes to achieve planned results.

ISO 9000, note 3, 3.4.1: where it is difficult or not economically feasible to verify the conformity of the end product, is often referred to as a "special process".

Generally accepted requirements for special production processes that ensure their validation:

1) certification of the production process (technology, methodology, work instructions ...)

2) qualification of production equipment (calibration of welding machines or robots, spray guns and paint supply systems...)

3) certification of materials (electrodes, gas, fluxes, paint, solvents, primers...)

4) personnel certification ( qualification requirements to welders or operators of welding robots, adjusters, service companies...)

with appropriate documentary evidence.

Specialist. (SP) must be under controlled conditions.

Managed conditions include:

Availability of information describing the characteristics of products and joint ventures;

Availability of regulatory, design and technological documentation;

Use of suitable equipment;

Availability and use of means of control and measurement;

Carrying out control, measurements and tests;

Implementation of activities for the implementation of the joint venture;

Availability of qualified and certified personnel implementing the JV;

re-validation;

Availability of records containing the results achieved or evidence of the activities carried out in the implementation of the SP.

How is validation different from verification?

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

Validation is confirmation, based on the presentation of objective evidence, that the requirements for a particular use or application are met.

Already the translation from English of these terms 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 goods and check if the requirements are met. The verification result is the answer to the question "Does it meet the requirements?".

But not always a product that meets the established requirements can be used in a particular situation. For example, the drug has 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 his own characteristics and specifically for this medicine can be detrimental, i.e. someone (physician) must confirm: yes, this patient can take this medicine. That is, the doctor must perform validation: to validate a specific application.

Or another example. produces pipes intended for laying in the ground, in accordance with certain specifications (technical conditions). Products comply with these specifications, but an order has been received, involving the laying of pipes along the seabed. Can pipes that comply with the existing specifications be used in this case? Validation is 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 there are requirements associated with a particular 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 the use of specific drugs by specific patients. Or the same AvtoVAZ.

Thus, the following can be stated:

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

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 products for specific conditions.

ISO 9001 refers to these terms in two places. Let's check whether the interpretation given by me corresponds to the content of sections 7.3.5, 7.3.6 and 7.5.2.

"7.3.5. Design and development verification. Verification shall be carried out in accordance with the planned activities (clause 7.3.1) to ensure that the design and development outputs meet the input requirements:".

"7.3.6. Design and development validation. Design and development validation shall 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 delivery or use of the product."

It is easy to see that the interpretation is in full agreement with the text of these sections. At the same time, I would like to draw attention to the fact that paragraph 7.3.5 refers to the correspondence of holidays data, and in clause 7.3.6 - products. This is essential! This means that the validation is not for the weekend data, but for products designed for specific conditions. For example, in the activities of the institute for the development of standard projects for residential buildings, validation is not required - only verification. But for the activity of developing 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. Company must validate all production and service processes, the results of which cannot be verified through consistent monitoring or measurement. These include all processes whose deficiencies become apparent only after the start of use of the product or after the provision of the service. Validation should demonstrate the ability of these processes to achieve intended results."

In technology or in the system management quality validation confirms that the requirements of the external acquirer or the user of the product, service or system is satisfied. Verification is usually an internal quality management process that ensures compliance with a rule, standard, or specification. Easy way to remember difference The difference between validation and verification lies in the fact that validation confirms that "you created the right product", and verification confirms that "you created the product as you intended to do it."

Document Validation

A valid web document is one that has gone through a similar procedure and has no comments on the code. The code of a web page must follow certain rules, called a specification, which is developed by W3 (www.w3c.org) with the support of browser developers.

At first glance, it seems that validation is necessary, because we are talking about reducing the number of developers' mistakes and writing the "correct" code. In reality, things are much more complicated, and validation is still hotly debated about its relevance. In order to objectively reveal this issue, we will further consider the pros and cons of such a check.

Although HTML code has a fairly simple hierarchical structure, it is easy to get confused in the code as the document grows, and therefore it is easy to make a mistake. Browsers, despite the obviously incorrect code, will try to display the web page anyway. But since there is no single regulation on how a “crooked” document should be displayed, each browser tries to do it in its own way. And this, in turn, leads to the fact that the same document may look different in popular browsers. Correcting obvious mistakes and systematizing the code leads, as a rule, to a stable result.

The times when browser manufacturers added unique features to their product against all standards are beginning to fade into the past. Each a new version browsers are becoming more specification-aware and render documents with little or no errors. Developers of sites that also adhere to the canons of web standards thus comply current trends development of web technologies.

Don't forget about XML (eXtensible Markup Language, Extensible Markup Language). This language is becoming the de facto standard for storing data and exchanging information between different applications. XML syntax is more rigid than HTML and does not forgive the slightest mistake. In a sense, XML is similar to programming languages ​​in which the program will not compile until the code is debugged. HTML is the first step to learning XML, so teaching yourself how to code properly will make it easier to move on to the next stage of HTML development.

Surprisingly, web developers also have their own fashion. The current fashion is to create valid documents and display a special icon in the form of a picture that the site complies with the HTML specification. This trend has even affected site customers, and when writing a technical task for the development of a site, some of them specifically stipulate that the site be made according to web standards.

In many ways, following standards brings many benefits that show up in small things and become noticeable when a certain critical mass is reached. In particular, the amount of code becomes smaller, more compact and more readable. Accordingly, for users, the loading speed of the site as a whole increases.

Websites, of course, are made for people to visit. It is the visitors who are the measure of the work of the site, and they are also interested in the way it is received. The user wants the site to display correctly in his favorite browser, load quickly and contain the materials that he needs. Note that this list does not contain anything about the document code and its validity, visitors are simply not interested in this. Therefore, a completely invalid site, but made with soul, filled with interesting materials will attract more visitors than an empty resource, but made according to all the "rules".

Browser developers do not always follow the specification and in some cases interpret the code not according to the given rules, but in their own way. Ultimately, this leads to the fact that a web page that is displayed correctly (that is, as the developers intended) in one browser is displayed with errors in another. Following the spec in cases like this is likely to turn off users of some browsers. For example, Internet Explorer (IE) currently occupies a leading position among browsers, but at the same time it does not support the HTML and CSS specification better than Firefox and Opera. Obviously, when IE users visit a site made according to all standards, but not taking into account the specifics of this browser, they will see an unsightly picture.

Customers of the site, as well as their developers, do not like this situation, so when faced with a choice: standards or a browser, they mostly choose a browser.

It turns out a disappointing picture - there is no particular need to spend time debugging the code to comply with the specification. It is better to devote this time to ensuring that the document works without problems in different browsers - this is how web developers mostly think.

XML and XHTML validation

In order to validate content, it must first be retrieved. The source (what we have to check against a set of certain rules) can be completely unpredictable:

remote source.

We abstract from the above sources, because in fact it doesn’t really matter to us where we get the data for validation from: they all end up as a string. After we have received the string, we need to process it in such a way as to obtain elements that we can work with in the programming language in which we are programming. To begin with, we must decide what entities we can turn the input data into. Recall that the basic unit in XML/XHTML is the element. From him we will repel. In addition to the element, we need a container of elements, which we will call a document.

Every XML/XHTML document consists of a set of elements, and there is always a root element that contains all the other elements. Wait! But it's just a normal tree! Yes, yes, that's right: we see a tree of elements in front of us. We have come to a rather important conclusion: any XML document (and a document in any XML-like language) can be represented as a tree. After that, with this tree, we can perform a very different set of operations: comparison, deletion, permutation, traversing (the operation of passing through all nodes of the tree), and others.

XML validation is incomparable easier to check XHTML: We just need to make sure a few requirements are met, which we can do quite easily given that we have a tree of elements. We systematize the necessary rules:

The first element in a document is always an XML header declaration of the view, where […] are XML header attributes;

All elements must be named correctly and must not contain extraneous characters (spaces, for example);

All attributes must be written in correct form(it is checked quite simply, with the same regular expression);

The document must contain only one root element;

The nesting of elements must be respected (checking this statement is achieved by using a stack of elements, with which we check the correspondence of opening and closing elements);

If all of the above rules are met, then the document is considered a valid XML document. Otherwise, the document contains errors, the list of which the validator can display to the user for review and correction.

XHTML validation is based on XML validation. First, we must make sure that the document is valid from the point of view of XML (that is, nesting of tags is observed, elements and their attributes are correctly formatted, and others), and only then impose additional rules. If a document is not valid in terms of XML, then it is certainly not valid in terms of XHTML.

To apply any XHTML rules to a document, you first need to describe those rules in a way that is easy to obtain and stencil on the document. For validating XHTML documents, rules can be stored in several formats:

DTD documents;

Regardless of the format, the following set of checks are performed:

Checking all used elements in the document for their presence in XHTML (if the element specified in the document does not exist, then an appropriate error is generated);

Availability check required attributes at the corresponding elements;

Checking the content type of some attributes for compliance with the types specified in the rules;

The element's content type must match the one specified in the rules;

Since XHTML defines element classes (block and text), the validator must make sure that elements of one class (level) must be correctly nested within elements of another class (level). Similar patterns are also described in the rules.

After executing the specified set of rules, we can say whether the document is valid or, on the contrary, contains some errors that the validator can indicate to the user.

GMP validation

GMP is a complex end-to-end solution for design, construction, operation and companies production requires a large financial and labor investment. This has already become a mandatory level for a pharmaceutical plant.

In practice, real experience and professional advice can help prevent design and equipment errors that can cause huge unrecoverable losses in investment, time and effort.

For a running plant: inspection of the plant in relation to the building, general technical condition, product range and related workshops, condition of equipment, structure and personnel, and knowledge and skills of personnel about GMP rules, quality control documentation and management, analyzing the degree of compliance with the requirement of the current GMP standard , will be overall plan work improvements and schedule. The two sides confirm and begin to materialize.

For a new facility: plant layout: general plan, design of technology, warehousing, quality, production process and gives comments or advice. Checks equipment selection and supplier

GMP accreditation not only requires appropriate facilities and equipment, but also a documentation system: duties of departments and positions, rules management, operation rules, quality control rules, quality standard, production batch records.

What is EITI Validation?

EITI Validation is a quality assurance mechanism and is an integral part of the EITI process. It has two main functions. First, it stimulates dialogue and learning at the country level. Second, it maintains a single global EITI standard across all implementing countries. Validation is not an audit. It is not a repetition of the disclosure and comparison process that is part of the EITI reporting process. Validation has more overarching goals: with stakeholder input, it evaluates the implementation of the EITI; evaluates the results for compliance with the global standard; and seeks ways to strengthen the development of the EITI process.

In addition, validation is a mechanism that is used to determine the status countries as a candidate country or countries meeting the EITI. IN currently 23 countries are candidates. All of these countries meet the four entry requirements and are at various stages of EITI implementation. In order to assess EITI compliance, the EITI requires countries to complete the validation process within two years.

Through validation, countries that demonstrate compliance with (or measurable progress towards) EITI requirements receive international recognition their efforts and achievements. If validation is not completed, or if it shows no measurable progress towards meeting EITI requirements, the EITI Board revokes Candidate country status.

The validation process takes place at the international level and is controlled by a multi-stakeholder group at the state level. validation is set out in the EITI Rules, including the Validation Guide.

The first step is the appointment of a validator by the multistakeholder group. The EITI Board has compiled a list of accredited EITI Validators and has provided guidance to implementing countries on nominating a Validator.

The selected validator uses three main documents in his work.

These are:

Country Work Plan

Validation Requirements and Method of Performance Evaluation, and

Company profiles

Using these documents, the validator meets with the multi-stakeholder group, is engaged by the company to verify data disclosed by companies, the government and other key stakeholders (including organizations and the public that are not part of the multi-stakeholder group).

Using this information, the validator completes a report that includes:

Concise overview report on progress in implementing the country workplan;

A concise overview report on progress towards the targets of the validation schedule;

Completed validation schedule;

Overview report on implementation by companies;

Aggregate questionnaires of companies;

Overall assessment of EITI implementation: whether the country is a Candidate, meets the requirements, whether or not there is notable progress.

This report first goes to the multi-stakeholder group, the government and the EITI Board. If these groups agree on the validation report, it is published and comments are accepted for execution. If there is disagreement about the validation process, then it is considered first at the local level. The EITI Board is only involved in cases of serious disagreement.

Sources

en.wikipedia.org Wikipedia - the free encyclopedia

htmlbook.ru For those who make websites

certicom.kiev.ua CertiCom

enumerate.ru In Search of Ordered Truth

luxunig.com Pharmaceutical engineering

Encyclopedia of the investor. 2013 .

Synonyms:

See what "Validation" is in other dictionaries:

Validation- giving legal force, approval, legalization, ratification. Dictionary of business terms. Akademik.ru. 2001 ... Glossary of business terms