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>
HACCP is a food safety management system that involves the analysis and control of biological, chemical, and physical hazards. The hazard study is conducted from the production of raw materials to the consumption of the final product, covering the processes of acquisition, handling, manufacturing, and distribution. Its acronym stands for Hazard Analysis and Critical Control … <a href="https://blog-cms.softexpert.com:8080/en/haccp/" class="more-link">Continue reading<span class="screen-reader-text"> "What is the HACCP system and how can you create your food safety strategy"</span></a>
The Non-Conformity Report (NCR) is a document that identifies and records discrepancies between the requirements defined by quality standards and the actual condition of a product, service, or process. It can be created by any area of a given organization, although it is more common in the manufacturing, production, and operations sectors. Non-conformity is an … <a href="https://blog-cms.softexpert.com:8080/en/non-conformance-report/" class="more-link">Continue reading<span class="screen-reader-text"> "Non-conformance report: what it is for and how to create one"</span></a>
Corrective action is a measure that aims to eliminate the cause of a problem. On the other hand, preventive action aims to eliminate the cause of potential issues that have not yet occurred. Both can be used to increase quality as well as prevent non-conformities – especially if you want to comply with ISO 9001. … <a href="https://blog-cms.softexpert.com:8080/en/corrective-and-preventive-action/" class="more-link">Continue reading<span class="screen-reader-text"> "Corrective and preventive action: what they are, their differences and how to apply them in your company"</span></a>
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>
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>
Learn about the differences between Quality Assurance and Quality Control in our infographic, including their different focuses and objectives.
Check out in this article how the Electronic Batch Records (EBR) assists pharmacists in ensuring compliance with your product.
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>