# Cybernetic Model Design for the Qualification of Pharmaceutical Facilities
## 3 Discussion and Model Verification, Validation, and Application
### Documentation Review Process and Release
Also, it is very important to understand the requirements of the regulation and the expectations of the regulatory authorities and how complex and comprehensive the process is. This is shown in [56], where the author defines complex actions and methods that auditors should implement during the inspection of pharmaceutical companies. The newly designed model shown in this paper is universal because its implementation satisfies regulatory guidelines and standards at the global level, where there are agreements on the recognition of jurisdictions, which aim to facilitate regulatory co-operation at the global level. The first model that could be applied to the qualification of pharmaceutical systems is defined as the \"V\" model, shown in Figure 1[7], which is too general and refers to different systems as well as process verifications. Even though little can be deduced from it, this model created the basis for the development of newer models. The model shown in Figure 3[10], has excellent practical application and is aimed at the qualification of pharmaceutical facilities in accordance with GMP, focusing on the traditional way of testing, DQ-IQ-QQ. A major drawback of the mentioned models is the absence of risk management throughout the entire qualification phase. Also, tests are vaguely defined, which defines the mentioned models as general. In accordance with the recommendations for the pharmaceutical industry, ISPE [17] defines a risk-based model: the model is not focused and fully applicable to the commissioning of pharmaceutical plants, but it provided the basis for the creation of the aforementioned cybernetic model for the qualification of pharmaceutical plants. The mentioned model does not provide the possibility for the qualification of computerized systems, decommissioning activities, or proposals for optimal plant operation and the qualification of plants that will \"save\" energy, resources, materials, or personnel. Additionally, in the mentioned guide, it is not stated how and on the basis of which research the conclusions were drawn. All existing models that can be applied to the qualification of pharmaceutical plants were created before August 2022, after which the new version of Annex-1 [39] was published, which significantly tightened the current standards and requirements for sterile production. The newly designed cybernetic model for pharmaceutical facilities qualification differs from previous models in several key aspects:  
* Comprehensive approach--unlike existing models that often focus on individual parts of the qualification process or provide a general overview, the cybernetic model presented in this paper takes a comprehensive approach. It considers all stages necessary for the qualification of pharmaceutical plants, providing a detailed and thorough framework. * Integration of practical experience--the model is based on practical experience gained from participating in 99 reconstructions, which has allowed for the standardization and definition of processes during system commissioning and qualifications. This integration of real-world experience sets it apart from purely theoretical models. * Focus on risk management and optimization--the model emphasizes aspects such as risk management, scientific approaches, experimental testing, numerical simulations, and energy-saving opportunities. By incorporating these elements, the model aims to enhance the efficiency and effectiveness of the qualification process. * Regulatory compliance--the model is designed to meet the requirements of regulatory authorities, ensuring that it aligns with industry standards and guidelines. This focus on regulatory compliance enhances the model's applicability and relevance in the pharmaceutical industry. * Universality and adaptability--the cybernetic model that has been presented is universal and adaptable, making it suitable for application in various types of pharmaceutical production technologies. Its flexibility allows for implementation in different settings, contributing to its versatility and practical utility.