In pharmaceutical operations, effective software compliance is vital for regulatory adherence, data ...

In the pharmaceutical industry, maintaining software compliance is a continuous process that extends...

In the pharmaceutical industry, ensuring compliance in software systems is vital for safeguarding da...

Imagine your pharmaceutical company has rolled out new software to manage your drug manufacturing pr...

The AI Act was formally adopted by the full European Parliament on 13 March, and we have reviewed th...

In earlier blog posts, we spotlighted the EU member states – Germany, Belgium, and France – and thei...

U.S. Basic Requirements for DTx Products Subject to the U.S. Health Authority (FDA) regulations, spe...

Digital therapeutics (DTx) represent an exciting frontier in healthcare, leveraging clinically valid...

Germany has always been renowned for its meticulous attention to detail, often described by the term...

All Digital Therapeutics (DTx) must adhere to the EU’s foundational CE marking requirements as detai...

In a landscape marked by escalating healthcare expenses and budgetary restrictions, mobile health (m...

In the rapidly evolving pharmaceutical industry, computerized systems play a vital role in drug deve...

Nowadays, pharmaceutical companies have an ever-increasing number of equipment, automation activitie...

Digital health in pharma is not just an emerging trend; it’s shaping the future of the pharmaceutica...

Automated software testing is becoming increasingly crucial in the GxP world, where Pharma 4.0 is th...

Pharmaceutical, clinical, MD, and IVD companies pursuing robustness in their software validation act...

Digital technology is transforming the way clinical trials are conducted, offering new opportunities...

Using software for your life sciences operations requires high integrity and security in the data pr...

In the world of life sciences, an endless stream of compliance documents is thrown around. It’s no d...

At the beginning of yet another new year, it is always interesting to take a moment to reflect on th...

Change control management is an essential part of any quality assurance system. It enables us to mai...

Artificial intelligence (AI) and machine learning (ML) are on the rise in our society, changing the ...

‘Digital health‘ is on the rise. It’s a term we use more and more often. But what is digital health?...

In the post-COVID pharmaceutical landscape, electronic records and signatures are indispensable, gui...

In the life science industry, Artificial Intelligence (AI) and Machine Learning (ML) validation have...

Current regulations require that manufacturing processes in the pharmaceutical industry be validated...

GAMP 5, which stands for “Good Automated Manufacturing Processes”, is an approach that has been wide...

Ever wondered why it is necessary – and sometimes absolutely essential – to perform a Data Migration...

Changes in business needs or technology are inevitable. They often lead to the retirement or “decomm...

During the pandemic, electronic signatures gained tremendous importance for companies in heavily reg...

New to validating computerized systems? If so, it might be difficult to get started on this type of ...

What does an automation pyramid entail? An automation pyramid visualizes the integrated layers of te...

GxP Processes At first glance, business processes are not important from a regulatory point of view....

When categorizing, GAMP5® takes two main aspects of a system into account: the complexity and the in...

In our first blog we discussed the definitions of validation and computerized systems. Assessing the...

The past of Computer Systems Validation has served us well and provided us with the foundation of wh...

Over the last couple of years, the data integrity topic has received more and more attention. Recent...