Quality control is a process within an organization to ensure that the quality of its product will be maintained or improved. It requires the company to create an environment of continuous improvement, where management and employees strive for perfection. This is just one of the many definitions created for quality control over the years, many … <a href="https://blog-cms.softexpert.com:8080/en/quality-control/" class="more-link">Continue reading<span class="screen-reader-text"> "What is quality control and how to implement it in your company"</span></a>
In the 1990s, the MedDRA (Medical Dictionary for Regulatory Activities) terminology was created to facilitate the international exchange of medical device regulatory information. The WHODrug is an international classification of medicines developed by the World Health Organization (WHO) and used in about 150 countries. Together, these initiatives help unify pharmacovigilance efforts around the world and … <a href="https://blog-cms.softexpert.com:8080/en/meddra-and-whodrug/" class="more-link">Continue reading<span class="screen-reader-text"> "MedDRA and WHODrug: understand how they impact the pharmaceutical market"</span></a>
A Normative Instruction (IN) from Anvisa (National Health Surveillance Agency) is a document that establishes the rules to be complied with by companies and professionals in various areas. With IN 134, quality standards were established for the computerized systems used in the manufacture of medicines. Thus, IN 134 includes in the form of Good Manufacturing … <a href="https://blog-cms.softexpert.com:8080/en/in-134/" class="more-link">Continue reading<span class="screen-reader-text"> "IN 134: what it is and how it affects the manufacture of medicines"</span></a>
Cloud security is a collection of security measures designed to protect a cloud-based infrastructure. These measures ensure user and device authentication, control over access to data and resources, and protect data privacy. The field of knowledge of cloud security also enables compliance of your data storage method with the legislation of the region where your … <a href="https://blog-cms.softexpert.com:8080/en/cloud-security/" class="more-link">Continue reading<span class="screen-reader-text"> "Cloud security: learn how to safeguard your business"</span></a>
Supplier management is not limited to the purchasing stage. Here are some aspects to improve the performance of your suppliers in a sustainable way.
Companies are looking for recognition when they acquire ISO certifications, but is that all they need? Learn more about the most important reasons to become ISO certified.
Enterprise cloud computing is here to stay: By 2025, 85% of organizations will adopt a cloud-first approach, according to Gartner, a renowned technology consulting firm. These companies are not joking, as the study states that they will not be able to execute their digital strategies without the use of native cloud-based architectures and technologies. There’s … <a href="https://blog-cms.softexpert.com:8080/en/cloud-computing-advantages/" class="more-link">Continue reading<span class="screen-reader-text"> "7 advantages of cloud computing to transform your business"</span></a>
Process management encompasses a variety of methods used to analyze, improve, and automate business processes. These actions aim to enable an organization to achieve its long-term strategic goals by ensuring that it stays on track. This approach focuses primarily on the results of procedures, rather than the tasks themselves. It dictates that teams and organizations … <a href="https://blog-cms.softexpert.com:8080/en/process-management-key-issues-and-how-to-solve-them/" class="more-link">Continue reading<span class="screen-reader-text"> "What is process management and what advantages does it bring to your business?"</span></a>
The Resolutions of the Collegiate Board are regulations created by Anvisa (National Health Surveillance Agency) to regulate several areas. In the Health sector, RDC 654 was published in 2022 and brings guidelines that talk about Good Manufacturing Practices for Active Pharmaceutical Ingredients. Thus, compliance with this RDC is essential for companies seeking to carry out … <a href="https://blog-cms.softexpert.com:8080/en/rdc-654/" class="more-link">Continue reading<span class="screen-reader-text"> "RDC 654: How it affects drug manufacturing"</span></a>
RDC 749/2022 is the Resolution of the Collegiate Board, created by Anvisa to regulate the exemption of bioequivalence/bioavailability studies in producing new drugs — which is called biowaiver. After being published, this resolution led to the revocation of the former RDC 37/1 RDC 37/11. The main objective of the new RDC is to ensure the … <a href="https://blog-cms.softexpert.com:8080/en/rdc-749-2022/" class="more-link">Continue reading<span class="screen-reader-text"> "Understand the changes of RDC 749 2022 in the pharmaceutical sector"</span></a>
A good and efficient design budget can be easily created, especially when you know what it should contain.
Cloud compliance is the process of ensuring compliance with national and international regulatory requirements within the scope of cloud computing. The practice also involves seeking compliance with industry best practices using frameworks and benchmarks. Companies that offer or use cloud-based services must comply with different laws in different territories. In Europe, the current law is … <a href="https://blog-cms.softexpert.com:8080/en/cloud-compliance/" class="more-link">Continue reading<span class="screen-reader-text"> "What is cloud compliance and how to implement it in your organization"</span></a>