CFR 21 part 11 and the electronic registry in the Life Sciences industry
The CFR 21 Part 11 is a standard of the United States Food and Drug Administration (FDA). It establishes the requirements and rules for the use of computerized automation systems in the pharmaceutical, biotechnology, and medical device industries. Therefore, it is widely followed all over the world. The CFR 21 Part 11 guidelines are part … <a href="https://blog-cms.softexpert.com:8080/en/cfr-21-part-11/" class="more-link">Continue reading<span class="screen-reader-text"> "CFR 21 part 11 and the electronic registry in the Life Sciences industry"</span></a>
What is the Digital Operational Resilience Act (DORA) and how to prepare for it
The Digital Operational Resilience Act (DORA) is a European Union regulation aimed at strengthening Information and Communication Technology (ICT) security in financial institutions such as banks, insurance companies, and investment firms. The goal is to enable the European financial sector to withstand critical operational disruptions. With the financial sector increasingly dependent on digital technologies, the … <a href="https://blog-cms.softexpert.com:8080/en/digital-operational-resilience-act/" class="more-link">Continue reading<span class="screen-reader-text"> "What is the Digital Operational Resilience Act (DORA) and how to prepare for it"</span></a>
What is quality assurance (QA) and how to apply it in your organization
Learn about the differences between Quality Assurance and Quality Control in our infographic, including their different focuses and objectives.
Electronic batch records (EBR): the traceability management of industry 4.0
Check out in this article how the Electronic Batch Records (EBR) assists pharmacists in ensuring compliance with your product.
What is quality control and how to implement it in your company
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>
MedDRA and WHODrug: understand how they impact the pharmaceutical market
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>
IN 134: what it is and how it affects the manufacture of medicines
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: learn how to safeguard your business
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>
What is supplier management and how to do it sustainably
Supplier management is not limited to the purchasing stage. Here are some aspects to improve the performance of your suppliers in a sustainable way.
What is the importance of ISO 9001 and what is it for?
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.
7 advantages of cloud computing to transform your business
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>
What is process management and what advantages does it bring to your business?
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>