Redator Kivalita em 27 de September de 2021 em Articles

System Validation: How to validate systems according to Guide 33/2020

Industrial plants cover a number of automation systems, aimed not only at accelerating productivity, but especially to ensure that the products produced are delivered to the market with the proper quality standard that the consumer deserves.

Managers need to understand, in detail, each of these systems that integrate the manufacturing phases of the products. More than that, it is necessary to maintain its constant updating and validation according to the best practices of the “Guide to Validation of Computerized Systems”, Guide No. 33/2020. Otherwise, there may be a critical commitment of the performance of the systems, which cease to generate the expected benefits and become a threat to production processes and, consequently, to the entire business.

Managing risks

Critical Process Parameters should be considered in order to be controlled, monitored and tracked by manufacturing systems throughout operations in the day-to-day production, in order to ensure effectiveness.

Quality risk management represents a systematic process that requires evaluation, control, communication and review, focusing on critical aspects of systems that can impact patient safety, product quality and data integrity. Here, quantitative and qualitative techniques can be applied to identify and manage risks.

Understanding the Life Cycle within the Quality Management System (QMS)

The Life Cycle within the QMS comprises from conception to retirement of the system. By deeply knowing each stage it is possible to gain greater visibility to promote improvements and continuous maintenance to the systems, through Good Practices. This helps anticipate solutions to potential failures, which could potentially unexpectedly disrupt system performance, comtain them, or worse: generate incalculable damage to the entire organization.

Several factors need to be addressed when moving forward with the validation of systems within the company such as their complexity, integration, impacts that can cause the business, scaling capacity, among others. Each employee will act as a Process Owner, Owner of the Specialist System in the Subject of the software installed in its industrial plant.

The life cycle approach refers to the definition of systemic activities, which cover the design, understanding of requirements, in addition to development, release and operational use, until the retirement of the system.

The ComputerIzed Systems Validation Guide (Guide No. 33/2020) outlines systems lifecycle activities as follows:

Concept: the company to be regulated considers the opportunity to automate one or more processes, based on their needs and benefits desired to the business. Here, the company decides to change an activity performed manually, to run it through a computerized system.

Design: This phase involves planning, evaluating and selecting the supplier, in addition to the various specification levels, configuration (or coding for custom applications), and finally a check that leads to acceptance and release to advance the operation. It is essential to address risk management in order to identify it, exclude or minimize it to an acceptable level. It is also at this stage that the acquisition and validation of the systems to be implemented are carried out.

Operation:This is undoubtedly the longest phase. It is managed from the use of operational procedures. We can say that it is equivalent, in practice, to the time of use of the computerized system validated by the company. It is necessary to be attentive to the need to manage possible changes arising from different impacts, scope and complexity. 

Retirement: refers to the final phase of the system lifecycle, involving decisions about data retention, migration or destruction and the management of these processes.

Therefore, in general, the purpose of system validation is to ensure that they are being properly used for their intended purposes. Failure to invest in advanced systems for proper data storage and validation can threaten business continuity. In addition to being a regulatory issue, system validation ensures data protection and, consequently, the ownership, integrity and quality of products to companies. 

Does your organization require system validation and risk management? See how Kivalita Consulting can help you!

Kivalita Consulting specializes  in the development of quality management and technology validation for companies, especially in the area of Life Science. That’s why we know the relevance of system validation and risk management to ensure data integrity for industries as part of efficient quality management. 

All systems can have a direct impact on product quality, and their validation is essential. Kivalita Consulting can help your business in mapping, from simple systems to larger systems such as “ERPs” or other industrial-scale automation.

Contact our experts and learn more!

By Bárbara Guelfi, Founder and CEO of Kivalita Consulting

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