In the pharmaceutical industry, a Quality Management System (QMS) is the backbone of your compliance...
Life Sciences Blog
Whether you're in pharma, biotech, medical devices, or any other industry, our diverse services and expert guidance are designed to keep you informed and ahead of industry trends. Dive into our content and stay connected with the latest advancements and best practices.
Life Sciences Blog
No Items Found! Please Try Some Different Keywords
The adoption of AI in the pharmaceutical industry is accelerating, but at a much slower pace than in...
Medical Device Software (MDSW) development can feel like a regulatory labyrinth, especially for star...
In the ever‑evolving life sciences industry, digitization is no longer optional — it’s a strategic i...
Cybersecurity has become a fundamental requirement under the Medical Device Regulation (MDR). Medica...
The European Commission is revising Annex 11 of the EU GMP guidelines, and it’s about time. Annex 11...
A Laboratory Information Management System (LIMS) is more than just software; it’s the operational b...
As of February 2, 2025, Article 4 of the EU AI Act is in force. This means AI providers and deployer...
In regulated environments such as pharmaceutical manufacturing, laboratory research, and clinical tr...
The pharmaceutical industry has seen its fair share of revolutions. From early mechanisation to comp...
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...
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...
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...
Over the last couple of years, the data integrity topic has received more and more attention. Recent...