Ana Paula Anton is a Product and Market Analyst at SoftExpert. She has a degree in Chemical Engineering and a post-graduate diploma in Production Engineering. She has experience in the areas of Processes and Pharmaceutical Quality Systems, in addition to expertise in Good Manufacturing Practices, Risk Management, Audits, Process Validation and Qualification, Cause Analysis, CAPA, FMEA and Validation of Computerized Systems.
ISO 42001 (also known as IEC 42001) is an international standard that sets standards for the adoption of an Artificial Intelligence Management System (AIMS). Although it is not mandatory, it is widely used in the market because it allows companies to create, implement, maintain, and continuously improve Artificial Intelligence management. In this way, the ISO 42001 standard ensures that AI tools are used responsibly, reliably, transparently, and ethically.
Quality assurance and regulatory compliance are vital for medical devices industries around the world to ensure product safety and efficacy. To facilitate global cooperation and improve the efficiency of audit processes, the Medical Device Single Audit Program (MDSAP) was developed. In this article, we will discuss MDSAP and its benefits for the medical device sector. … <a href="https://blog-cms.softexpert.com:8080/en/mdsap-single-system-for-medical-devices/" class="more-link">Continue reading<span class="screen-reader-text"> "MDSAP: A single audit system for quality in the medical device sector."</span></a>
In the highly regulated pharmaceutical industry, every process, however controlled it may be, is subject to deviations, occurrences or unusual production situations that can impact product quality. These deviations pose a serious threat to the efficacy, safety and quality of drugs and should be addressed as nonconformities. In this article, we will discuss the importance … <a href="https://blog-cms.softexpert.com:8080/en/nonconformities-capa-pharmaceutical-companies/" class="more-link">Continue reading<span class="screen-reader-text"> "Nonconformities and CAPA: how to ensure the quality and safety of drugs in the pharmaceutical industry"</span></a>
