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How to keep computerized systems in the operational phase?

Computerized systems play a crucial role in the life sciences, as these systems are used in daily activities such as data management, key processes, and...

From IVDD to IVDR: avoid these pitfalls to get your CE marking in time

In vitro diagnostic (IVD) medical devices (Manufacturers | Internal Market, Industry, Entrepreneurship and SMEs (europa.eu)) have gained a lot of...

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Are systems in compliance with ISO 80002-2 if we follow the guidelines described in GAMP5?

In the world of life sciences, an endless stream of compliance documents is thrown around. It’s no different for computerized systems. It’s not always that...

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What is a medical device? Key definitions and regulations around the world.

What is a medical device? This crucial question often arises when bringing medical devices to market. Determining whether your product qualifies as a...

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SCADA Automation in Pharma: Boosting Efficiency and Compliance

Imagine a world where countless operators meticulously monitored dials and switches, ensuring the precise production of life-saving...

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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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IVDR Transitional Extension: Why full speed ahead is still the best strategy

In the dynamic landscape of medical device regulations, the recent proposal by the European Commission to extend the transitional...

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Starting a new job in Corona times: this is how Katrien experienced it at QbD

Katrien Coppens has joined our QbD back office team and is mainly responsible for finance topics. Her onboarding is an adventure she won’t easily forget. “Not...

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State Of The Art Literature Review – Process and Documentation

A comprehensive, objective, and thorough systematic literature review to describe the general State of the Art and identify all relevant clinical safety,...

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Maintaining Validation Excellence: Continuous Improvement Through Periodic Validation Reviews in Pharma

What’s the Goal of a Periodic Validation Review?

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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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Mastering EU Product Information: The Role of the EMA’s Linguistic Review Process in Centralised Procedures

For Medicinal Products, the Product Information (PI) is a key document that provides a summary of officially approved information for Healthcare...

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The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical Devices

The European Parliament has adopted the proposal to extend the transitional period for legacy devices (i.e. those covered by a certificate or...

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Friability and disintegration for oral solid dose forms: the forgotten tests

Friability and disintegration testing are often overlooked during pharmaceutical development or testing; however, they play a certain role in...

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Article 31 Referrals in Pharmacovigilance: A Brief Overview

In the world of pharmaceuticals, ensuring the safety and efficacy of medicines is paramount. One crucial mechanism for maintaining these standards within...

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Analytical Method Transfer: Common Pitfalls and How to Avoid Them

Analytical method transfers (AMTs) are a critical step in the drug-development timeline. AMTs often occur due to sequential activities, such as...

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Elevate Pharma Imports with EU GMP Annexes 16 and 21

In the world of pharma imports, maintaining Good Manufacturing Practice (GMP) standards is a shared responsibility that transcends borders. The...

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The Role of Artificial Intelligence (AI) in Pharmacovigilance in Europe: Advances and Legislation

The safety of medicines is a fundamental concern in the field of public health, and in Europe, pharmacovigilance plays a crucial role in ensuring...

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In-House Devices (IHDs): The Impact of IVDR, ISO 15189:2022’s Update, and MDCG 2023-1 in the EU

In May 2022, the European Union (EU) ushered in the In Vitro Diagnostic Regulation (IVDR), marking a significant transition from the previous In...

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What to expect when being inspected?

In a previous blog post “Regulatory Inspection Readiness: A Proactive Approach to CAPA and Compliance” we talked about the steps to take after the...

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Why do I still need to look at my QMS under the IVDR if it is ISO 13485 certified?

In the In Vitro Diagnostic (IVD) medical device industry, adhering to regulatory requirements is paramount to ensure IVDs are...

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Impact of PDE values on cleaning validation design in pharmaceutical manufacturing

Toxicology is fundamental throughout the drug life cycle, beginning with the evaluation of active substances in animals during the pre-clinical...

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Safeguarding Drugs: Controlling Elemental Impurities (ICH Q3D)

Elemental impurities might not be the first thing you think of when it comes to drug safety, but they are crucial to understand. These impurities ...

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Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment

As we strive to improve our health with new medicines, it’s crucial we don’t forget the impact these advances could have on the environment. The...

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A Deeper Dive into the MHRA Good Pharmacovigilance Practice (GPvP) Inspection Metrics and Findings

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has been conducting Good Pharmacovigilance Practice (GPvP) inspections since 2003. Any...

Declaration of Equivalence for Medical Devices under the MDR

With the Medical Device Regulation (MDR 2017/745) being more stringent than the previous European Medical Device Directive (MDD) or the Active...

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ICH Q2(R2) Validation of Analytical Procedures: An Overview of the Revised Guideline

Introduction Did you know that the precision of analytical methods directly influences the safety and efficacy of pharmaceutical products? Understanding...

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How to create a GMP-Compliant Stability Protocol?

Introduction to Stability Testing in Pharmaceuticals Stability testing is a regulatory and scientific mandate to guarantee that pharmaceutical...

Digital Therapeutics in the UK: The Post-Brexit Landscape

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Pharmacovigilance (PV) Audits: importance, process, and challenges

In healthcare, safeguarding patient safety and upholding the integrity of pharmaceutical interventions are paramount. Enter pharmacovigilance (PV), a...

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Quality and Regulatory Affairs: Key Elements of a Robust QMS in Pharma for Compliance and Success

In the complex and highly regulated world of pharmaceuticals, thesynergy between Quality and Regulatory Affairsis not just crucial, it’s indispensable....

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Continuous manufacturing in the pharmaceutical industry: enhancing drug production

A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutical industry. Unlike the more commonly used batch...

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MHRA’s International Recognition Procedure Post Brexit: Navigating Medicinal Product Registration in the UK

One of the initial changes implemented by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) following Brexit was introducing a...

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Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations

Software Medical Devices (or Medical Device Software, as it is generally referred to in the EU), is often mistaken to be the same as Software As Medical...

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CE approval for Medical Devices under MDR: key requirements for your device class

Conformity assessments for CE approval As indicated on the website of the European Commission, a medical device can only be...

Qualifying a new GMP facility: from pitfalls to best practices

In pharmaceutical production, a GMP (Good Manufacturing Practices) facility stands as a testament to stringent quality control and precision....

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Importing medicinal products into the EU? A brief guide to EU GMP compliance.

In an era of increasing globalization, the pharmaceutical landscape is undergoing significant changes. This blog post offers a structured insight...

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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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Understanding plasmids: small molecules with big implications

Plasmids are used in various research and biotechnology applications, such as gene therapy, vaccine development, and recombinant protein production.

Paperless Validation in Pharma: embrace the future

Nowadays, pharmaceutical companies have an ever-increasing number of equipment, automation activities, and computerized systems to streamline their...

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The regulatory pathway for your custom-made medical device

Custom-made medical devices are the odd ones out when it comes to the Medical Devices Regulation (EU) 2017/745. The MDR mentions “other than...

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GMP-compliant design of climate or stability chambers: the key to ensuring product integrity

Stability testing serves as the backbone of regulatory compliance for pharmaceutical companies, providing crucial insights into the durability and...

4 Factors Influencing the Stability of Medicinal Products

Ensuring the stability of medicinal products is crucial for maintaining their effectiveness and safety throughout their shelf life. Numerous factors come...

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Mastering Cleanroom Qualification: navigating the latest regulatory updates

In 2022, significant updates were made to the main standards that impact the qualification of cleanrooms. These updates include: EU GMP...

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Computerized System Validation in clinical trials: key considerations

Computerized systems have become an integral part of clinical research, from data collection to analysis and reporting. However, ensuring the accuracy,...

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State of the Art (SOTA) Literature Review – What, Why, When, and Who?

State of the Art (SOTA) literature review is part of the clinical evaluation process of a medical device, which is defined as an ongoing collection,...

Pharma 4.0: The Future of Pharmaceutical Manufacturing

Industry 4.0 refers to the fourth industrial revolution, and within the pharmaceutical industry, there is a specific term called Pharma 4.0. It involves...

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The Importance of Stability Testing in Pharmaceutical Development

Stability testing plays a crucial role in the development of medicinal products, ensuring that they maintain their quality, safety, and efficacy...

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EudraLex Volume 4 Annex 11: compliance checklist and future prospects

What is EudraLex Volume 4 Annex 11? EudraLex Annex 11 serves as a reference document within the European Union‘s pharmaceutical industry. It...

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MDR transition: how to plan MDR compliance for your Medical Device?

In June 2022, concerns were expressed that severe challenges related to the implementation of Regulation (EU) 2017/745 on medical devices (MDR) would...

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Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare

Nowadays, regulations on medical devices and medicinal products have very strict expectations on documents outlining the benefits and performance and...

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Analytical Method Validation: are your analytical methods suitable for intended use?

What is Analytical Method Validation? Analytical method validation is a critical process in the pharmaceutical, biotechnology, and food industries...

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ILAP: Introduction to the UK’s Innovative Licensing and Access Pathway

In order to give patients quicker access to cutting-edge treatments and therapies, the UK government introduced a pathway in 2021 called “Innovative...

What is the Agile model in Computerized System Validation?

Pharmaceutical, clinical, MD, and IVD companies pursuing robustness in their software validation activities can use either the V-model or the Agile model....

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EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products – Summary and first insights

EU GMP Annex 1’s revision – the 2022 update to ‘ Manufacture of Sterile Medicinal Products‘ – aimed to eliminate ambiguities and inconsistencies while...

7 key areas to focus on during internal or supplier audits

Regulatory agencies require internal and supplier auditsin the pharmaceutical and medical device industry to ensure products are safe and effective....

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8 steps to successfully respond to non-conformities in an inspection report

Pharmaceutical companies are often inspected by competent authorities to verify the manufacturer’s compliance with regulatory requirements to ensure...

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Introduction to Digital Health in Clinical Trials

Digital technology is transforming the way clinical trials are conducted, offering new opportunities to improve patient experience, data quality, and trial...

What is the GAMP 5 V-model in Computerized System Validation?

Using software for your life sciences operations requires high integrity and security in the data processing. Your computer systems must be designed to...

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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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Qualification of laboratory equipment: key considerations and challenges

The introduction of a new product into your company’s portfolio may require expanding your existing laboratories or even building a new laboratory to...

UDI for software: how to mark your MDSW with a UDI?

We recently published a blog post about Unique Device Identifiers (UDI). While this blog post briefly explains what a UDI is and how to implement it on...

Change Control Management: how to keep your systems compliant?

Change control management is an essential part of any quality assurance system. It enables us to maintain control of the validated status and always be in...

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The Advent of Artificial Intelligence and Machine Learning in Medical Devices

Artificial intelligence (AI) and machine learning (ML) are on the rise in our society, changing the landscape of our daily lives, just think about...

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Medical Device development: the importance of Design Transfer and Process Validation

Bringing a Medical Device to market involves many hurdles, including medical device design and medical device development. While the design and development...

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Annual Product Quality Review (APQR / PQR) in Pharma: importance, benefits & challenges

Current regulations require written documentation for all existing products in the company; this documentation is known as the A nnual Product Quality...

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Finding your way through the maze of international, European, and harmonized standards for medical devices

ISO, IEC, EN ISO… References to standards can be confusing. What is the difference between these standards? What are harmonized standards and what is their...

AI and machine learning validation: strategies and examples

In the life science industry, Artificial Intelligence (AI) and Machine Learning (ML) validation have been the buzzwords of the past year. Every...

What is the purpose of Periodic Reviews in CSV?

Current regulations require that manufacturing processes in the pharmaceutical industry be validated , and once validated, they must be continuously...

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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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Why self-inspections or internal audits are essential for your QMS

Any company in the pharmaceutical or medical device industry with a certified GMP, GDP or ISO 13485 Quality Management System must conduct self-inspections...

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PRRC under MDR and IVDR: meaning, requirements, and responsibilities

PRRC: meaning of this new role under MDR and IVDR The Person Responsible for Regulatory Compliance or ‘PRRC’ is a mandatory role introduced by the ...

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New GMP Annex 21 ‘Importation of Medicinal Products’ – Are you ready?

Current EU regulatory framework for MIA holders In recent years, medicinal products for the EU market are increasingly manufactured outside the EU ...

What is decommissioning in CSV?

Changes in business needs or technology are inevitable. They often lead to the retirement or “decommissioning” of computerized systems. ERP systems, for...

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Clinical Evaluation Report (CER): a must-have for all medical device classifications

Clinical evaluation of a medical device – defined as an ongoing collection, generation, appraisal, and analysis of clinical data related to your device –...

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Clinical Evaluation Plan (CEP): roadmap of the clinical evaluation strategy

Clinical evaluation of a medical device is central to obtaining and maintain ing market approval in the EU. For planning and documenting...

EDQM and the CEP of the future

Before marketing a medicinal product, pharmaceutical companies must obtain a marketing authorization (MA) from the respective licensing authority. In...

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CAR-T cell therapy: main components, manufacturing, and prospects

CAR-T cell therapy, a groundbreaking advancement in the pharmaceutical industry over the last 20 years, exemplifies the innovative strides made in areas...

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GAMP categories for computerized systems: what are they and what are they for?

New to validating computerized systems? If so, it might be difficult to get started on this type of validation. Why? Because, even if you have experience...

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3D printing medical devices: enabling patient-specific solutions for a better quality of care

Additive manufacturing, particularly 3D printing, has attracted strong attention of the medical devices and medical community at large over the past...

Cell therapy as an ATMP: introduction, definition, and subtypes

Cell therapy, a key component of Advanced Therapy Medicinal Products (ATMPs), represents a groundbreaking approach in modern medicine. Defined by the EMA...

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10 Questions for ‘10Y anniversary boy’ Jeroen Verhoeven

Jeroen and Bart at Bart’s bachelor party If you know that QbD was founded 10 years ago, then it won’t come as a surprise to you...

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Natural Killer (NK) cells: a major breakthrough in the field of ATMPs

Natural Killer cells or NK cells are large lymphocytes (white blood cells) that play a crucial role in our innate immune system. The innate immune system,...

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Medical device combination products: what regulations should you apply before marketing them in the EU?

In recent years, more and more medicinal products (MP) are used in conjunction with a medical device (MD). These are called “ combination products”....

MDR impact on MDSW: what has changed from MDD?

Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)? Or will affect the CE marking of your first or next...

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QbD Academy welcomes 15 young graduates to jumpstart their careers in life sciences

QbD Academy in a nutshell What is the QbD Academy? The QbD Academy is a young graduates program that combines working and learning...

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SaMD versus MDSW: what’s the difference between Software as a Medical Device and Medical Device SoftWare?

Nowadays, digital healthcare is taking an increasingly important place in the medical world through medical software, image processing, diagnostic support,...

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10 things you should know before validating Computerized Systems

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The key role of Regulatory Affairs in the pharmaceutical industry: from development to commercialization

Regulatory Affairs plays a crucial role in the pharmaceutical industry, especially during drug development: a lengthy, complex, and extremely costly but...

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Stay up to date with the latest in life sciences

One of our previous blogposts discussed innovations in the medical technology field and how these can fulfill unmet patients’ and physicians’ needs by...

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Quality by design methodology for the pharmaceutical industry

How to guarantee medicine quality and patient safety To explain the quality by design methodology, it’s important to first pay attention to how the quality...

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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...

Antleron & QbD team up to create a landslide in healthcare

A whole new era in healthcare is coming closer every day. Thanks to the crossover of 3D printing and biology, medical solutions will be personalized like...

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Data integrity in the pharma industry – a short introduction

Over the last couple of years, the data integrity topic has received more and more attention. Recently, the American Food and Drug...

How to define your Clinical Performance Strategy?

1. Start with a clear intended purpose A strong clinical performance strategy begins with a well-definedIntended Purpose. This statement...

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Life Sciences Blog

Life Sciences Blog

Don't miss the latest updates in life sciences

How to keep computerized systems in the operational phase?

From IVDD to IVDR: avoid these pitfalls to get your CE marking in time

Are systems in compliance with ISO 80002-2 if we follow the guidelines described in GAMP5?

What is a medical device? Key definitions and regulations around the world.

SCADA Automation in Pharma: Boosting Efficiency and Compliance

Mobile Health Ascending and the WHO’s Global Strategy on Digital Health

IVDR Transitional Extension: Why full speed ahead is still the best strategy

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Starting a new job in Corona times: this is how Katrien experienced it at QbD

State Of The Art Literature Review – Process and Documentation

Maintaining Validation Excellence: Continuous Improvement Through Periodic Validation Reviews in Pharma

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

Mastering EU Product Information: The Role of the EMA’s Linguistic Review Process in Centralised Procedures

The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical Devices

Friability and disintegration for oral solid dose forms: the forgotten tests

Article 31 Referrals in Pharmacovigilance: A Brief Overview

Analytical Method Transfer: Common Pitfalls and How to Avoid Them

Elevate Pharma Imports with EU GMP Annexes 16 and 21

The Role of Artificial Intelligence (AI) in Pharmacovigilance in Europe: Advances and Legislation

In-House Devices (IHDs): The Impact of IVDR, ISO 15189:2022’s Update, and MDCG 2023-1 in the EU

What to expect when being inspected?

Why do I still need to look at my QMS under the IVDR if it is ISO 13485 certified?

Impact of PDE values on cleaning validation design in pharmaceutical manufacturing

Safeguarding Drugs: Controlling Elemental Impurities (ICH Q3D)

Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment

A Deeper Dive into the MHRA Good Pharmacovigilance Practice (GPvP) Inspection Metrics and Findings

Declaration of Equivalence for Medical Devices under the MDR

ICH Q2(R2) Validation of Analytical Procedures: An Overview of the Revised Guideline

How to create a GMP-Compliant Stability Protocol?

Digital Therapeutics in the UK: The Post-Brexit Landscape

Pharmacovigilance (PV) Audits: importance, process, and challenges

Quality and Regulatory Affairs: Key Elements of a Robust QMS in Pharma for Compliance and Success

Continuous manufacturing in the pharmaceutical industry: enhancing drug production

MHRA’s International Recognition Procedure Post Brexit: Navigating Medicinal Product Registration in the UK

Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations

CE approval for Medical Devices under MDR: key requirements for your device class

Qualifying a new GMP facility: from pitfalls to best practices

Importing medicinal products into the EU? A brief guide to EU GMP compliance.

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

Understanding plasmids: small molecules with big implications

Paperless Validation in Pharma: embrace the future

The regulatory pathway for your custom-made medical device

GMP-compliant design of climate or stability chambers: the key to ensuring product integrity

4 Factors Influencing the Stability of Medicinal Products

Mastering Cleanroom Qualification: navigating the latest regulatory updates

Computerized System Validation in clinical trials: key considerations

State of the Art (SOTA) Literature Review – What, Why, When, and Who?

Pharma 4.0: The Future of Pharmaceutical Manufacturing

The Importance of Stability Testing in Pharmaceutical Development

EudraLex Volume 4 Annex 11: compliance checklist and future prospects

MDR transition: how to plan MDR compliance for your Medical Device?

Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare

Analytical Method Validation: are your analytical methods suitable for intended use?

ILAP: Introduction to the UK’s Innovative Licensing and Access Pathway

What is the Agile model in Computerized System Validation?

EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products – Summary and first insights

7 key areas to focus on during internal or supplier audits

8 steps to successfully respond to non-conformities in an inspection report

Introduction to Digital Health in Clinical Trials

What is the GAMP 5 V-model in Computerized System Validation?

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

Qualification of laboratory equipment: key considerations and challenges

UDI for software: how to mark your MDSW with a UDI?

Change Control Management: how to keep your systems compliant?

The Advent of Artificial Intelligence and Machine Learning in Medical Devices

Medical Device development: the importance of Design Transfer and Process Validation

Annual Product Quality Review (APQR / PQR) in Pharma: importance, benefits & challenges

Finding your way through the maze of international, European, and harmonized standards for medical devices

AI and machine learning validation: strategies and examples

What is the purpose of Periodic Reviews in CSV?

GAMP 5 guide 2nd edition: what’s new?

Why self-inspections or internal audits are essential for your QMS

PRRC under MDR and IVDR: meaning, requirements, and responsibilities

New GMP Annex 21 ‘Importation of Medicinal Products’ – Are you ready?

What is decommissioning in CSV?

Clinical Evaluation Report (CER): a must-have for all medical device classifications

Clinical Evaluation Plan (CEP): roadmap of the clinical evaluation strategy