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medAspis, a pioneering pharmtech company, stands at the forefront of the market in providing cutting-edge Software as a Service (SaaS)...

In this continuation of our review of FDA and EMA compliance actions in 2024, we delve deeper into some of the most significant warning...

As we continue to reflect on the cybersecurity landscape of 2024, it's evident that this year has been marked by numerous significant...

In 2024, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) took significant actions to ensure...

As we look back at 2024, it’s clear that the cybersecurity landscape has been more challenging than ever. Here, we highlight some of the...

Nonconformance management ensures that any deviation from internal procedures, contractual agreements, laws and regulations are...

Although many companies understand the importance of the Software Development Lifecycle (SDLC) in producing quality software, they often...

In the dynamic world of software development, updates are a constant but they come with their own set of risks. This article explores...

A Quality Management System (QMS) is a collection of processes and responsibilities, part of organizational governance, aimed at...

Agile Software Development Software Development - Quality Assurance - Regulatory Compliance Test automation offers numerous benefits that...

Computerized Systems Validation (CSV) Part 10 Quality Assurance - CSV - Software Validation - SDLC Once a system is validated it needs to...

Computerized Systems Validation (CSV) Part 9 Quality Assurance - CSV - Software Validation - SDLC Data migration, the transfer of data...

Computerized Systems Validation (CSV) Part 8 Quality Assurance - CSV - Software Validation - SDLC Testing is a whole subject in itself....

Computerized Systems Validation (CSV) Design review is an essential part of computer systems validation. At this phase, the quality of...

Computerized Systems Validation (CSV) Following the specification of user requirements, the design specification outlines how the system...

Computerized Systems Validation (CSV) This is the fifth in a series of posts on general aspects of Computerized Systems Validation (CSV)...

Computerized Systems Validation (CSV) This is the fourth in a series of posts on general aspects of Computerized Systems Validation (CSV)...

Computerized Systems Validation (CSV) This is the third one in a series of posts on general aspects of Computerized Systems Validation...

Computerized Systems Validation (CSV) This is the second one in a series of posts on general aspects of Computerized Systems Validation...

Computerized Systems Validation (CSV) This is the first one in a series of posts on general aspects of Computerized Systems Validation...