Systems Validation: what should we consider?

What are the differences in Systems Validation within various industry segments?

Understanding the distinctions in Systems Validation is a common concern for regulated industries entering these activities, such as cosmetics, health products, medical gases, among others.

This is a critical topic because computerized systems have replaced functions once performed by humans, impacting various processes like batch traceability, raw material and product release, input management, proper positioning of materials and products, temperature, humidity, pressure management, and product handling. The absence of validation and periodic monitoring can jeopardize data security, product quality, and efficacy.

While specific aspects may vary, some points are universally relevant to all regulated industries, as outlined in ANVISA’s Computerized Systems Validation Guide from 2010. It’s important to note that this guide is not exclusive to the pharmaceutical segment, despite its simultaneous publication with RDC 17/2010 (pharmaceutical application).

Key considerations include functionalities related to access control. Regardless of the product, proper handling, packaging, and analysis must be based on correct parameters and data. ANVISA’s guide emphasizes access control as a crucial part of the validation process, addressing user security requirements and access levels based on roles within the company.

Beyond these general aspects, specific considerations are essential for system validation across various regulated industries. For instance, when validating an ERP system, ensuring the use of only approved raw materials is critical. Different standards provide requirements for this control, emphasizing the importance of validating this point in both the pharmaceutical and non-pharmaceutical sectors.

In conclusion, several critical points must be addressed when following Good Practices, necessitating comprehensive and clear documentation specifying system requirements. Whether acquiring a new system or assessing an existing one, the use of documents like the user requirements specification or risk analysis matrix is vital to ensuring compliance with industry standards.

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