Why does system validation need to be considered in your company's cybersecurity plan?
By Barbara Guelfi, Kivalita's CEO
The issue of cybersecurity in business - which is the fact that companies have resources to protect their privacy and the data that travel on their computers, servers and corporate networks against cybercriminal attacks - should be a priority issue on the part of entrepreneurs and managers of organizations of any size and segment. For the Life Science sector (which includes the pharmaceutical, food, cosmetic and chemical industries), for example - it is no different.
Cybercriminals are increasingly audacious, applying more sophisticated attacks that target consumers and businesses. This scenario has also worsened due to the conflicts between Russia and Ukraine. Avast, a global digital security and privacy company, recently warned that it has seen shared initiatives on social media that encourage ordinary people to become hackers by downloading tools to support so-called DDoS attacks against targets in Russia. This type of attack (DDoS) is a way to make online services unavailable to your users. However, an analysis of this type of tool shows that it is not secure because it collects sensitive data that can make users identifiable, such as their IP address, country code, city, location from IP address, user name, hardware configuration, and system language.
Another important disclosed data released by Avast in the last year was that the probability of a corporate user in Brazil finding any type of malware for PC is 17.52%.
The importance of system validation
For all these reasons, it is essential that the company's cybersecurity plan includes systems with strong layers of data protection and privacy, and more than that, consider validating these software in a way that meets business expectations.
With systems validation ( VSC) it is possible to ensure the integrity of corporate data, including as part of efficient quality management. By failing to invest in advanced and appropriate data protection systems, it can expose them to vulnerabilities that can impact business continuity.
In cases where companies fail to validate their systems, such as manufacturing systems (MES), LIMS (Laboratory information management system) and others that store patient data, (e.g. pharmacovigilance), they increase the risk of errors in production processes, data loss and recall needs, for example. Not to mention, this lack of validation in the cybersecurity scenario can expose vulnerabilities that could lead to the leak of sensitive corporate information.
In addition to being a regulatory issue, system validation ensures the protection of company information and, consequently, the ownership, integrity and quality of its products for the Life Science market. In these validations, the premises of ABNT ISO/IEC 27001 and Anvisa Guide 33 for companies regulated by it in the area of Life Science (Pharmaceutical, cosmetic, chemical, sanitist, veterinary and food industries and importers are considered.)
If you want to learn more about system validation, also read our article "Why validate your computerized system?"
Helping your business with validation challenges
In addition to being an important part of the cybersecurity plan for companies, system validation has a direct impact on product quality.
To advance the issue, Kivalita Consulting can help your company map its systems, ranging from excel spreadsheets to higher-scale software such as "ERPs" or other industrial-scale automation. Our professionals can contribute to the construction of a real history of the actions performed in the system by its users, facilitating the structuring, treatment, management and protection of more reliable information for efficient and assertive use in the future.
Talk to our experts and learn more!