Guilherme Not is a journalist and works as a Content Marketing Analyst at SoftExpert, specializing in SEO and content marketing strategies for highly regulated industries. With extensive experience in digital marketing, traffic generation, and lead qualification, he develops in-depth and strategic content. Guilherme combines advanced data interpretation with market analysis to develop the most relevant content across multiple channels and for diverse audiences. Author of articles, ebooks, infographics, social media, case studies, and many other formats, he writes about digital transformation, processes, and management solutions for companies seeking to connect valuable information with high-level insights in regulated markets.
RDC 982/2025 establishes a new health risk management model and continuous compliance monitoring as the basis for granting, renewing, or canceling the Certificate of Good Manufacturing Practices (CBPF) and the Certificate of Good Distribution and/or Storage Practices (CBPDA).
The essential guide to Regulatory Standard 7 of the PCMSO. Understand what the regulation is, its legal obligations, required medical exams, and the step-by-step compliance process. Avoid fines!
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.
File management software allows you to store documents, track versions and audit trails with traceability, and manage configurable permissions per user. With all this, it is possible not only to store items but also to act collaboratively in real-time with secure access between different sectors of a company.
A RDC 658 dispõe sobre as diretrizes gerais de Boas Práticas de Fabricação (BPF) de Medicamentos no Brasil. Publicada em 30 de março de 2022 pela Diretoria Colegiada da Anvisa, ela revogou a resolução anterior de 2019, que já tinha sido um marco para a categoria. Na prática, a RDC 658/22 não modifica o entendimento … <a href="https://blog-cms.softexpert.com:8080/en/rdc-658-22-good-manufacturing-practices-for-medicines/" class="more-link">Continue reading<span class="screen-reader-text"> "RDC 658/22: good manufacturing practices for medicines"</span></a>
A GRC (Governance, Risk & Compliance) system is a comprehensive tool that integrates governance, risk management, and regulatory compliance processes into a single platform. It unifies policies, controls, and reporting by eliminating organizational silos, automating workflows, and providing centralized visibility into a company’s risks and compliance obligations. This type of software is based precisely on … <a href="https://blog-cms.softexpert.com:8080/en/grc-systems/" class="more-link">Continue reading<span class="screen-reader-text"> "The 8 Best GRC Systems: How to Choose the Right Solution for Your Business"</span></a>
A CAPA (Corrective and Preventive Action) process is part of the good practices of quality management systems, such as the ISO 9001 and ISO 13485 standards. It is critical to ensure quality and compliance in the manufacturing industry. By proactively identifying the root causes of non-conformities and implementing effective actions, companies reduce rework, operating costs, … <a href="https://blog-cms.softexpert.com:8080/en/capa-in-the-manufacturing-industry/" class="more-link">Continue reading<span class="screen-reader-text"> "How an efficient CAPA process reduces non-conformities in the manufacturing industry"</span></a>
GFSI is the acronym for the Global Food Safety Initiative. This is the name given to a global collaboration of food industry stakeholders. This organization aims to promote continuous improvement in food safety management systems throughout the supply chain. Keep reading to find out how this organization became a global reference on the subject. Today, … <a href="https://blog-cms.softexpert.com:8080/en/gfsi/" class="more-link">Continue reading<span class="screen-reader-text"> "What is GFSI and what is its role in food safety"</span></a>
With the beginning of the year, it’s time to plan activities, strategies, and goals for the coming months. So that you can complete this challenge with maximum efficiency, we have prepared a list of the eight best quality management software that your company needs to know. Free Download: Quality Management Template Kit What is software … <a href="https://blog-cms.softexpert.com:8080/en/best-quality-management-software/" class="more-link">Continue reading<span class="screen-reader-text"> "8 best quality management software for 2025"</span></a>
