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The Quality Audits should be managed according to the Quality Management System requirements , which...
Life Sciences Blog
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Life Sciences Blog
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...
On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regu...
With rapid advancements in medical technology reshaping healthcare, new devices and innovations are ...
Imagine your pharmaceutical company has rolled out new software to manage your drug manufacturing pr...
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...
The last two years have seen significant changes in the approval management of clinical trials. In t...
Are you performing clinical research with medical devices? In this blog post, we provide a brief ove...
GAMP 5, which stands for “Good Automated Manufacturing Processes”, is an approach that has been wide...
A job in life sciences consultancy offers plenty of challenges, variety, career opportunities, and g...
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...
Hurdles to be taken As ATMPs progress towards commercialization, engineering challenges increase alo...
In our first blog we discussed the definitions of validation and computerized systems. Assessing the...
First of all, let’s take a look at the manufacturing flow of vaccines. The production process consis...
Imagine guiding someone through Excel’s myriad functions in a written manual. Where to begin? With b...
After months of revision and many questions raised, it now appears that the time is coming to implem...
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