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Software Validation

Software Validation
The concept of validation includes all the processes that need to be done in order to prove that the preferred and applied method is correct. In addition, validation ensures that expectations are fully met. If a study has been carried out with a validated method, then it is assured that that process is undoubtedly consistent and reliable. In this sense, it is interpreted as a powerful validation and provisioning mechanism. The starting point is compliance with predetermined criteria.


Software Validation / Software Validation also forms the basis of ISO 9000-like quality systems. Validation is not performed by users of that system. This process is absolutely managed by independent third parties. This is a very important detail for the reliability of the result. Software Validation / All processes specific to Software Validation must be officially documented. A rule called "write what you have done" appears to apply. Validation is sometimes used interchangeably with the concept of qualification.


Software validation is clearly articulated in the ISO 13485:2016 revision. With this update, software validation becomes a necessity. Software Validation / Software Validation is extremely important and necessary for businesses. In particular, manufacturers´ compliance with legal regulations plays a critical role in terms of their corporate image and reliability. At the same time, this compliance will provide signs that businesses are proactive and open to improvement. Compliance of the products or services with the rules can be ensured through validation procedures. Information systems preferred in production processes directly affect production decisions. The accuracy and efficiency of the software used to achieve this is completely controlled by Software Validation.


Why is Software Validation Important?


Software validation can be thought of as a type of validation concept. In many other areas these controls are provided reliably. Software Validation / Software Validation minimizes the value losses of the brand. It increases the level of security and creates tests for performance. This means that your business will gain certain financial advantages in the medium or long distance. In particular, minimizing the mistakes that will be reflected on the patients can be interpreted as an important development for a sensitive area such as health.

In addition to the firmware, it is necessary to prove that the criteria determined in many stages, from design to after-sales follow-up, are met. Software Validation basically supports this proofing process. For example, software such as aftermarket monitoring or enterprise resource planning are examples of this. Software Validation establishes a comprehensive testing process. The fact that it is a fast and reliable test makes it much more special. With this validation, you can see how much below or above the targeted quality the software operating from production devices is.

Software Validation / Software Validation is generally considered as a new concept. Manufacturers may have difficulties at certain stages from time to time, especially due to the lack of experience and practice of personnel in this regard. In particular, manufacturing companies that do business at a universal level even create a sub-team assigned only to this job. Manufacturers who do not have such a technical and financial means seek professional support. As Aşan Danışmanlık, we offer a consultancy service in which we convey our experience in Software Validation. You can contact us at any time for fast and professional solutions.

Software Validation is a must for very sensitive software such as ERP or e-KYS. You can easily find out from the companies you supply whether this type of software has any validation.


How does validation take place?


Every software you use needs to be validated in accordance with the target in your production processes. The expression "Software Validation Protocol" is used for this process. In this way, you can more clearly determine which software needs validation.

Software Validation / Software Validation is required to improve the performance and security of medical devices. For this, some important standards, especially ISO 13485:2016, serve as a guide. The extent of data integrity, storage of data or transfer of data has an important role in quality management systems. All controls that make up parameter limits, system architecture, hardware features and test methods are documented. If you are outsourcing the software directly, planning, testing and coding should be done at all stages of design before purchasing, if you prefer to develop the software yourself.

Software Validation topics approaches it as a risk. It proves the validation in a way that is intended for use, in accordance with the purpose of use, with documents. Software Validation is now considered a GMP requirement today. These needs need support.


Software Validation Phases


Software Validation, which is extremely important for the success of companies, consists of basic stages:

• Software validation in ISO standards

• Dairy life to software

• The place where the risk analysis is done

• For software

• Checking students from the right education

• Software design and implementation

• Migration documentation of preference software

• Traceability and giveaway

• Quality control for software