The concept of “validation” is used in various areas of human activity. The main point of validation is to verify the stated requirements that are required to achieve the established goal.
Basic meanings of the term "validation"
The two terms “validation” and “verification” should not be confused; there is a significant difference between them. Validation - what is it? In simple terms, we can say this: it is the process of providing objective evidence that the requirements of a certain external consumer or user of a service/product/system are fully satisfied.
When is validation necessary?
According to the international quality standard ISO 9001, an enterprise is obliged to certify all production and service activities if the final product cannot be verified by monitoring or subsequent measurement, and, as a result, deficiencies can only be identified after the provision of the service or use of the product. It follows that for all actions to obtain products that are carried out outside the production walls, 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 obtaining the required results. If, during validation or based on the results, the indicators receive a poor rating, all resources used are automatically written off as losses.
Equipment Validation
When producing equipment, all manufacturers indicate the specified properties of the product. These include:
- Terms of Use.
- Weight.
- Dimensions.
- Power supply parameters, etc.
Typically, users are primarily interested in: performance range, reliability and stability. It is the last two indicators that are studied during the inspection. Validation - what is it in simple words? Indications:
- For equipment that has been installed for the first time, it is necessary to carry out validation, and it is also recommended to do this after any movement.
- The frequency with which the validation is repeated determines the consistency of the equipment's performance.
- The frequency of equipment validation and analysis of the results is agreed upon with the customer. In some cases, equipment testing must be carried out on the eve of launch or after a long period of inactivity.
Process Validation
Production validation involves proving that the process will produce the specified results. The check 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 must be carried out each time the line is started or after a long period of inactivity. In this case, a simplified validation plan is used, but the evaluation is more thorough.
Product Validation
Product validation differs from other types in that in this case the entire production chain is taken into account (but not replaced), including equipment and process verification. The purpose of the audit is to certify that all procedures and processes performed will result in 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 a quality management system in accordance with ISO 9000 standards
Validation is confirmation, based on the provision of evidence, that requirements that are intended for a specific application or use have been fulfilled (ISO 9000:2005). There is a confirmation procedure by conducting an examination and providing objective information.
Validation steps:
- In development and design, approval indicates that a product has been assessed to determine whether it meets consumer needs.
- The approval process is usually carried out on the final product and under specified operating conditions. In some cases, validation is carried out early in production.
- The term "approved" is used to indicate the appropriate status. When a product is used in many ways, approval occurs multiple times (ISO 8402:1994, clause 2.18).
Differences between validation and verification
Verification is generally an internal process of regulating the quality of a product, which occurs in accordance with instructions, samples and specifications. What is the difference between validation and verification?
- Validation is confirmation that you have produced the correct product.
- Verification is confirmation that the product turned out the way you wanted it to be produced.
An example of standard verification is performing equipment testing.
- Obtaining/confirming requirements and standards for the product.
- Carrying out tests.
- Recording results, checking for compliance with requirements.
- Verification results.
Even if a product fully meets the requirements, it may not always be possible to use it in a particular situation.
Examples
For example, a medical product passed all the necessary tests and went on sale. Does this mean that any patient can take it? No, since any patient has characteristics of the body, and the drug can cause harm directly in his situation, so the patient should consult with the treating 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 terms, this is a test of a product for use 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 in accordance with specifications (technical conditions). The product fully meets the requirements, but an order has been placed for laying pipes on the seabed. In this case, can pipes intended for laying in the ground be used for laying under water? It is the validation that will answer the question posed.
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 cases where requirements arise related to a specific use of the product. If a pharmaceutical factory produces medications, it only checks for compliance with established requirements and will not deal with the use of certain medications by patients.
From this we can highlight the following:
- Verification is a constant process, and it is performed by comparing product characteristics with the stated requirements, as a result of which a decision is made on compliance/non-compliance with these requirements.
- Validation is carried out as needed and is carried out by examining the established conditions of use and assessing the compliance of product characteristics with these conditions, as a result of which a decision is made on the use of the product in a specific situation.
To summarize, we will answer the question: validation - what is it? In simple terms, this is a confirmation that is created on the basis of objective evidence that the conditions for a specific use or application have been accurately and fully met, which means that the stated goal has been achieved.
There is more than one interpretation of what validation is and what verification is, but all of them are not written in the simplest words, and to understand what the essence is is a task worthy of a prize.
We will look at these two terms from a slightly different angle to show an easy-to-understand example.
So, verification And validationusing the example of a pirate ship:
So, verification:
Ship hull? - There is
Mast? - There is
Jolly Roger? - No
Steering wheel? - No
Sail? - There is
Is everything there? - No
Validation:
Does the ship even float? Does the ship float on the water?
Verification–confirmation that certain requirements have been met.
Validation–checking that the product meets user expectations and needs.
Let's consider the above terms in practice.
Let's assume there is a website/application or some other creation.
To enter “this” we need to register/log in.
So, we have a form with fields that need to be filled in:
To begin with, let's conductverification:
We are checking availability of fields. All fields must comply with the specification. Their presence is determined by the designers creating the layouts. The necessary information is entered into the technical specification, and in the absence of such – It is advisable to have access to mockups.
When conducting verification, we initially assume that all fields are working, and it is possible to enter various data in them according to their names.
As part of the validation, it is checkedinformation entered into the fieldsand its compliance with the specification:
Let's look at another, more detailed example based on the login/authorization of the social network Facebook:
Let's assume that we have a specification and the presence of fields on the landing page corresponds to it. Based on thisverification was successful.
As you can see in the screenshot, the entered data was not validated and we were not allowed to proceed further, which is what needed to be checked.
Brief summary:
- during verification, the presence of something is checked;
- during validation – the performance of this “something”.
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 presentation of objective evidence, that the requirements intended for a particular use or application are fulfilled.”
It would seem that the definitions almost coincide, and if not completely, then to a significant extent. And, nevertheless, verification and validation are fundamentally different actions.
Let's figure it out.
Already the translation from English of these terms provides some food for understanding the difference: verification - verification, validation - giving legal force.
To make it easier to understand, I’ll 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 verification result 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 specific situation. For example, the medicine passed all the required tests and went on sale. Does this mean that it can be used by any specific patient? No, because each patient has his 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 doctor must perform validation: give legal validity to a specific application.
Or another example. The company produces pipes intended for laying in the ground in accordance with certain specifications (Technical Conditions). The products comply with these specifications, but an order has been received that involves laying pipes along the seabed. Can pipes that comply with the existing specifications be used in this case? It is validation that provides 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 only appears when requirements arise related to a specific product application. If a pharmaceutical plant produces drugs, 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, the following can be stated:
verification - is almost always carried out, performed by checking (comparing) the characteristics of products with specified requirements, the result is a conclusion about the conformity (or non-conformity) 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 whether my interpretation corresponds to the contents of sections 7.3.5, 7.3.6 and 7.5.2 .
"7.3.5. Verification of design and development. Verification shall be carried out in accordance with planned activities (clause 7.3.1) to ensure that the design and development outputs meet the input requirements...”
« 7.3.6. Validation of design and development. Validation of the design and development shall be carried out in accordance with the planned activities (clause 7.3.1) to ensure that the resulting product meets the requirements for its 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 clause 7.3.5 talks about compliance of output data, and clause 7.3.6 - products. This is significant! This means that 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 designs 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 location, 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 product has been used or the service has been provided. Validation must demonstrate the ability of these processes to achieve planned results...”
There are no discrepancies here either. But 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 are the activities of Quality Control Department?
Answer: this is verification.
Question: what are the activities of auditors?
Answer: to verification.
Question: what function does the signer of the act of commissioning an object (service, etc.) perform?
Answer: It does validation.
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Validation - what is it in simple words?How is validation different from verification? The answers to these questions are in the article.
Many words “validation” and “verification” are considered synonymous. But that's not true. There is a difference, but it is very subtle. Let's figure it out.
Validation and verification - what is it in simple words?
To be fair, it must be said that in different areas of activity (in banks, in payment systems, on the Internet), in different industries, these terms are used differently. I decided to bring it here definition of validation and verification from the ISO 9000 standard.
We see that the definitions coincide to a large extent, but not completely. However, despite this great coincidence validation and verification are different actions.
To make it easier to understand what validation is, let’s first understand how validation differs from verification.
— legalization, approval, legalization, ratification
(general civil law);
- a process that allows you to determine how accurately a certain model represents given entities of the real world from the perspective of a potential user
(system Programming);
— a procedure that provides a high degree of 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 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 of determining: accuracy, reproducibility, sensitivity, stability (interlaboratory reproducibility), linearity and other metrological characteristics
(GMP - Good Manufacturing Practice, is a mandatory requirement in the production of medicines).
In relation to quality management systems according to ISO 9000 series standards:
Validation— confirmation, based on the provision of objective evidence, that the requirements intended for a particular use or application are fulfilled
(ISO 9000:2005)
Validation— confirmation by examination and provision of objective evidence that the specific requirements intended for a particular application are met.
Notes:
- In design and development, approval means an examination of the product to determine whether it meets customer needs.
- Approval is usually carried out on the final product under specified operating conditions. It may be necessary at earlier stages.
- The term "approved" is used to indicate the appropriate status.
- Multiple approvals may be made if different uses are expected.
(ISO 8402:1994, clause 2.18)
According to PIC/S definition, this is:
“Actions that demonstrate, in accordance with GMP principles, that a particular technique, process, equipment, raw material, activity or system actually produces the expected results.”
Validation
Validation studies should promote good manufacturing practices; they should be carried out in accordance with established procedures. Results and conclusions must be documented in protocols.
If a new production recipe or a new manufacturing method is introduced, steps must be taken to demonstrate its suitability for mass production. It must be proven that the established process, using specified substances and equipment, consistently produces products of the required quality.
Significant changes to the manufacturing process, including any change in equipment or materials that may affect product quality and/or process reproducibility, must be validated.
Processes and procedures should be subject to periodic critical revision to ensure that they continue to achieve the expected results.
Validation and documentation
The goal of validation is simple: to prove that the object being validated actually produces the expected results. In other words, validation must show that the manufacturer has complete control over the production process. Validation is an integral part of "quality assurance", showing that the manufacturer understands the reasons for process variability and, mainly, understands what parameters need to be controlled to ensure process stability. Effective validation is based on risk management and the state of the art.
The procedures for the validation process should be documented in a set of protocols and the results of the validation should be documented in records or reports.
These documents are used in various forms when obtaining marketing authorization and inspection in accordance with GMP rules and also for internal production purposes so that the management of the organization can be confident that it is in control of its processes. Documentation of the validation process is the basis for the necessary regulation. But in order to avoid
Because of the error that often occurs when implementing 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 GMP rules, validation “consists of documented confirmation of the compliance of equipment, production conditions, quality of raw materials and finished product with current regulations and/or requirements of regulatory documentation.” This approach is outdated. Its consequences are quite harmful. From various publications one may get the impression that the validation process is nothing more than a documentation process or that words such as “validation”, “verification”, “qualification” and “test” are, in fact, analogues of each other. Lack of understanding of “validation” perpetuates misunderstanding of GMP, and creates a situation where staff resist implementation of GMP, simply accepting it as an “ever-growing mountain of paperwork.”
In EC GMP (and, by the way, FDA GMP), validation is the regular examination of systems, processes, engineering systems and, of course, the pharmaceutical product itself, to provide a high level of confidence that processes have been properly designed and controlled.
Effective validation requires a risk-based approach, a thorough understanding of manufacturing processes and improving their sustainability through the implementation of new technologies. Thus, validation is a dynamic process. This fact obviously poses some challenges for regulators.
From the point of view of drug developers and manufacturers, validation can provide the following benefits:
- better understanding of processes and therefore, reducing risk while preventing problems and ensuring smooth process management;
- reducing the cost of eliminating deficiencies;
- reducing the risk of non-compliance with regulatory requirements.
Once a process has been fully validated, it is possible that the number of parameters monitored at the end of the process will be reduced. Designers, by fully understanding those parameters that influence variability and therefore process stability, have the necessary information to control the process, for example, by reducing variability or increasing process speed. Although "validation" is an integral part of "quality assurance", there is a clear relationship between validation and the management system. In order to effectively conduct validation, company management must determine its policy on this issue. One of the first elements that an FDA or PIC/S inspector intends to examine is the validation policy.
