Knowledge

Document management: what it is, its benefits and tools to put into practice

Document management encompasses all the processes and actions that a company uses to manage its documents efficiently and securely. This requires a defined and effective structure to create, store, organize, control access and dispose of this type of material — whether physical or digital. Thus, electronic document management is essential for companies that seek not … <a href="https://blog-cms.softexpert.com:8080/en/document-management/" class="more-link">Continue reading<span class="screen-reader-text"> "Document management: what it is, its benefits and tools to put into practice"</span></a>

7 methods and tools for risk identification

Read this article to learn about 7 methods and tools for risk identification and improve your organization's competitiveness and performance.

What is change management, what is it for, and what are the methodologies

Change management is a systematic approach to dealing with the transition or transformation of an organization’s goals, processes, or technologies. It involves preparing and supporting employees, leaders, and teams during the process of organizational changes. The main objective of change management is to implement strategies to control transformations and help people adapt to them. To … <a href="https://blog-cms.softexpert.com:8080/en/change-management/" class="more-link">Continue reading<span class="screen-reader-text"> "What is change management, what is it for, and what are the methodologies"</span></a>

Quality Week 2024: from compliance to performance!

Learn more about World Quality Week 2023 and discover how to achieve your competitive potential through quality.

Certification audit: what it is, how to do it and its benefits

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>

What is the HACCP system and how can you create your food safety strategy

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>

Non-conformance report: what it is for and how to create one

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 and preventive action: what they are, their differences and how to apply them in your company

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>

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.