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Life Sciences Blog

Stay updated with the latest insights in life sciences! Our blog explores cutting-edge advancements, regulatory updates, and expert perspectives across pharmaceuticals, biotechnology, and medical devices. From innovation to implementation, discover valuable knowledge to support quality and compliance in the life science industry.

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Life Sciences Blog

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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Operational%20Software%20Compliance%20that%20Adds%20Value%20Essential%20Pharma%20Q&A%20.jpg

Operational software compliance that adds value: essential pharma Q&A

In pharmaceutical operations, effective software compliance is vital for regulatory adherence, data security, and the integrity of patient-critical...
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Operational software compliance in pharma: a practical guide

In the pharmaceutical industry, maintaining software compliance is a continuous process that extends beyond initial validation. The computerized system...
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Essential steps for pharma software compliance in the operational phase

In the pharmaceutical industry, ensuring compliance in software systems is vital for safeguarding data integrity, patient safety, and regulatory adherence....
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Status of the medical device regulatory landscape: An interview between QBD Group and Irdeto

On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regulatory landscape. This is the transcribed...
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Technovigilance in Action: Safeguarding Health with Post-Market Surveillance of Medical Devices

With rapid advancements in medical technology reshaping healthcare, new devices and innovations are emerging faster than ever before. From innovative...
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Why Combining Scripted and Unscripted Testing Boosts Your CSV Strategy

Imagine your pharmaceutical company has rolled out new software to manage your drug manufacturing processes, believing the system was fully validated....
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Digital Therapeutics in the UK: The Post-Brexit Landscape

In earlier blog posts, we spotlighted the EU member states – Germany, Belgium, and France – and their adoption of the fast-track procedure for...
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Exploring the U.S. Regulatory Framework for Mobile Health

U.S. Basic Requirements for DTx Products Subject to the U.S. Health Authority (FDA) regulations, specifically under ‘CFR Title 21...
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Mobile Health Ascending and the WHO’s Global Strategy on Digital Health

Digital therapeutics (DTx) represent an exciting frontier in healthcare, leveraging clinically validated digital technologies to enhance health and...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/Digital-Therapeutics-DTx-in-Germany-Pioneering-Deutsche-Grundlichkeit-with-Quality-by-Design-1.png

Digital Therapeutics (DTx) in Germany: Pioneering “Deutsche Gründlichkeit” with Quality by Design

Germany has always been renowned for its meticulous attention to detail, often described by the term ‘Deutsche Gründlichkeit’. It’s no wonder then,...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/The-DTx-Landscape-in-Belgium-France-and-their-inspiration-from-the-German-Model-1.png

The DTx Landscape in Belgium, France, and Their Inspiration from the German Model

All Digital Therapeutics (DTx) must adhere to the EU’s foundational CE marking requirements as detailed in our blog post on the ‘ EU regulatory landscape...
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Quality Audits Management: Quality Audits managed according to QMS 

The Quality Audits should be managed according to the Quality Management System requirements , which should include: A risk-based planification...
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The Rise of Mobile Health: Taking a Closer Look at the EU Regulatory Landscape

In a landscape marked by escalating healthcare expenses and budgetary restrictions, mobile health (mHealth) has emerged as a game-changer. Endorsed by the...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/Computer-Software-Assurance-CSA-in-Pharma-Industry-First-Steps-to-move-from-CSV-to-CSA--1.png

Computer Software Assurance (CSA) in Pharma Industry: First Steps to move from CSV to CSA 

In the rapidly evolving pharmaceutical industry, computerized systems play a vital role in drug development, manufacturing, quality control, and...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Blog%20-%20A%20Deep%20Dive%20into%20Clinical%20Trials%20Regulations%20Shifts%20and%20Strategies%20in%20the%20UK%20and%20EU%20-%20QbD%20Group.jpg

A Deep Dive into Clinical Trials Regulations: Shifts and Strategies in the UK and EU

The last two years have seen significant changes in the approval management of clinical trials. In the UK, the Combine Review system became mandatory...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/Essential-Documents-in-Clinical-Investigations-with-Medical-Devices-a-brief-overview-QbD-Group-1.jpg

Essential Documents in Clinical Investigations with Medical Devices: a brief overview

Are you performing clinical research with medical devices? In this blog post, we provide a brief overview of essential documents required during a...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/New-edition-of-the-GAMP-5-guide-%E2%80%98A-Risk-Based-Approach-to-compliant-GxP-Computerized-Systems-expected-in-2022-1.jpg

GAMP 5 guide 2nd edition: what’s new?

GAMP 5, which stands for “Good Automated Manufacturing Processes”, is an approach that has been widely used in life science industries for validating...
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6 common myths about life sciences consultancy

A job in life sciences consultancy offers plenty of challenges, variety, career opportunities, and growth, but it is still shrouded in myth and mystery
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Automation Pyramid – FAQ

What does an automation pyramid entail? An automation pyramid visualizes the integrated layers of technology used in manufacturing or industry combined...
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What to focus on when validating a computer system? (3)

GxP Processes At first glance, business processes are not important from a regulatory point of view. However, it is necessary to assess them if the...
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What to focus on when validating a computer system? (2)

When categorizing, GAMP5® takes two main aspects of a system into account: the complexity and the inherent risk. The more standard and tested software is, the...
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ATMP manufacturing for the market: main hurdles to be tackled to ensure a high-quality end product.

Hurdles to be taken As ATMPs progress towards commercialization, engineering challenges increase along with the increased number of patients and collection...
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What to focus on when validating a computer system

In our first blog we discussed the definitions of validation and computerized systems. Assessing the health of the system means checking whether the system...
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Market release of vaccines: European Union versus the United States of America

First of all, let’s take a look at the manufacturing flow of vaccines. The production process consists of various stages. It all starts with the raw...
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Technical Writing in Pharma and Biotech: Essential Tips

Imagine guiding someone through Excel’s myriad functions in a written manual. Where to begin? With basics like opening the program and creating...
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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/EU-GMP-Annex-I-Are-we-ready-for-the-challenges-posed-after-its-revision-1.png

EU GMP Annex I: Are we ready for the challenges posed after its revision?

After months of revision and many questions raised, it now appears that the time is coming to implement the new requirements contained in the revision of...
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