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).
Product design centered on compliance transforms regulations into competitive advantage. Discover how modular frameworks and AI create scalable, user-friendly solutions for regulated markets.
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!
A certification audit is the entire process of analyzing and evaluating a company to find out if it meets the requirements of a specific standard. This evaluation needs to be thorough and impartial and can be done internally or by an independent entity. A quality certification audit is usually conducted when a company wants to … <a href="https://blog-cms.softexpert.com:8080/en/certification-audit/" class="more-link">Continue reading<span class="screen-reader-text"> "Certification audit: what it is, how to do it and its benefits"</span></a>
The acronym RDC stands for Collegiate Board Resolution, which is a type of regulatory standard created by the collegiate board of Anvisa (Brazil’s National Health Surveillance Agency). In general, an RDC establishes the rules, guidelines, and procedures that a corporation must follow. The most common resolutions regulate areas such as health, education and the environment. … <a href="https://blog-cms.softexpert.com:8080/en/what-is-rdc/" class="more-link">Continue reading<span class="screen-reader-text"> "What is RDC (Resolution of the Collegiate Board)?"</span></a>
Regulatory affairs are the norms, rules, and procedures created to set limits on the work done by companies in various sectors. These rules can be established by government agencies, regulatory entities, or even by the companies themselves. These compliances are the laws, regulations, and guidelines specific to each industry. See how regulatory affairs help maintain … <a href="https://blog-cms.softexpert.com:8080/en/regulatory-affairs/" class="more-link">Continue reading<span class="screen-reader-text"> "What are regulatory affairs and why is they important?"</span></a>
Information protection is an extremely important topic for the interconnected and globalized world in which we live today. The entire digital infrastructure of modern society, including business, international trade and social media, depends on technologies and services that need to be protected. We can mention threats such as intrusions, unauthorized access, data loss, among others. … <a href="https://blog-cms.softexpert.com:8080/en/iso-27001-10-step-implementation-guide/" class="more-link">Continue reading<span class="screen-reader-text"> "ISO 27001: Complete 10-step implementation guide"</span></a>
Information security is a corporate governance responsibility. It cannot be seen as an isolated initiative of the Information Technology team and should be handled as a business strategy topic. Within this perspective, organizations have struggled to protect controlled, critical, or confidential information from improper access that could cause irreversible damage to the business. The ISO … <a href="https://blog-cms.softexpert.com:8080/en/do-you-know-latest-features-iso-iec-270012022/" class="more-link">Continue reading<span class="screen-reader-text"> "Do you know the latest features of ISO/IEC 27001:2022?"</span></a>
