On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regulatory landscape. Read the interview here.
On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regulatory landscape. Read the interview here.
In this blog post, we explore Computer Software Assurance (CSA), a modern alternative to traditional Computer System Validation (CSV), focusing on its crucial role in the pharmaceutical industry. Discover the key differences between CSA and CSV, the initial steps for transitioning from CSV to CSA, and why the CSA approach is increasingly important for ensuring system reliability, security, and compliance in drug development and manufacturing.
Explore the essentials of plasmid manufacturing and regulations for applications like gene therapy and vaccine development.
Oncolytic viruses and cellular immunotherapy are creating significant new potential in the fight against cancer. Learn more about the working mechanism, risks, and specific biosafety requirements to be considered for oncolytic viruses.
Discover the future of pharma: enhancing efficiency and cutting costs with paperless validation. Learn how to navigate the path to agility and innovation in the digital era.
In this blog post, we delve into the world of GMP-compliant design for climate chambers, unraveling the vital role they play in the stability testing of pharmaceutical products.
In this blog post, we address key regulatory guidelines for stability testing to ensure high-quality products meet regulatory requirements and patient needs.
In this blog post, we would like to share with you the different steps and required documents for the execution of the systematic literature review for the clinical evaluation of your medical device.
In this blog post, we will explore the various factors that influence the stability of medicinal products and the parameters that need to be considered during their storage.
Discover the latest key changes in cleanroom qualification regulations, exploring the impact of the different test phases (qualification, classification, requalification, monitoring) with a focus on risk assessment.
Discover the importance of software validation in clinical trials. Learn how it applies to GCP and GMP systems. Stay ahead in the digital era.
In this blog post, we would like to share with you the definitions, time points, and resources required to execute a systematic State of the Art (SOTA) literature review as required.
In this blog post, we will delve deeper into the significance of stability testing in pharmaceutical development.
Discover how Pharma 4.0 is revolutionizing pharmaceutical manufacturing. Learn about the benefits, challenges and key components and how it improves efficiency, quality and patient safety.
In this blogpost, we are sharing our experience on the common gaps and hurdles that manufacturers are facing when undertaking this Systematic Literature Review (SOTA).
This article addresses the latest revision of EudraLex Volume 4 Annex 11 and provides a checklist for compliance. Download it now.
The EU Commission is proposing a general reform of pharmaceutical legislation. Read more about what this means for patients and the industry.
Maintaining computerized systems during the operational phase is critical to the proper functioning of organizations. In this article, we explore some of the best practices for doing so.
Explore the field of medical writing and the different types of medical writing projects in Healthcare. QbD Clinical is happy to help!
Struggling with CSV validation and testing automation? Tired of re-validating at every sprint? Discover expert tips to reduce time, and budget, and increase validation coverage in our latest blog post on automated software testing for the GxP world.
In this blog post, you will learn more about analytical method validation and the criteria to consider when validating your analytical method.
Although manufacturers will have more time to prepare their technical files for the MDR transition, it is wise not to delay implementation until the last minute. Learn how to plan MDR compliance for your medical device here.
The UK government introduced the Innovative Licensing and Access Pathway (ILAP) in 2021 to give patients quicker access to cutting-edge treatments and therapies by offering a streamlined approach to licensing and regulatory processes. Learn more about ILAP in this blog post.
QbD Group Ltd. attended the MHRA GMDP symposium, a highly anticipated annual event that brings together stakeholders in the pharmaceutical industry to discuss the latest trends and developments. Discover our insights here.
Want to introduce robustness into your software validation activities? In this article, you will learn what the Agile model is and how to use the GAMP 5 framework for agile development.
The EU GMP Annex 1 Manufacture of Sterile Medicinal Products was revised in 2022. In this blog post, we will provide a summary of the changes and our initial insights several months after the revision.
Annex XVI of the MDR EU 2017/745 lists products without an intended medical purpose that now fall under the MDR. In this blog post, you will learn more about the contents and requirements of the annex.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is developing a new IT system to streamline submissions related to product licensing and process licensing. The first release of the system is expected by the end of 2023, with subsequent releases incorporating wider elements such as medical devices and import notifications. An agile delivery model will enable continuous improvement based on user feedback.
Regulatory agencies impose internal audits and supplier audits in the pharmaceutical and medical device industries to ensure compliance with Good Manufacturing Practices and ISO standard requirements. These audits help identify potential problems that may affect product quality, efficacy or safety, and provide a mechanism for implementing corrective actions to minimize public health risks. In this blog post, we’ll discuss 7 key areas to focus on during internal or supplier audits.
Learn 8 logical steps to take prompt action when national competent authority inspection reports, EIRs, FDA Forms 483 or warning letters show non-conformities. Failure to act can have crippling consequences.
In celebration of International Women’s Day, we sat down with Elly De Bruyn, Chief Human Resources Officer (CHRO) at the QbD Group, to talk about her experiences and views as a power lady in the life sciences industry.
Want to introduce robustness into your software validation activities? In this article, you will learn what the GAMP 5 V-model is and the key steps within it.
This blog post provides an overview of essential documents required during medical device clinical investigations in accordance with ISO14155:2020.
The European Parliament has approved a proposal to extend the transitional deadlines for certain medical devices under the MDR to ensure availability of devices whose certificates have expired or will expire before 26 May 2024. Manufacturers must adhere to specific conditions to comply with the new transition periods. Learn more here.
Are you about to qualify your laboratory equipment? If so, here are the key considerations and challenges to consider.
Each individual medical device must have a Unique Device Identifier (UDI) with its carrier (barcode or QR code). But what about medical device software? Read the answer in this article!
Can the computerized system validation used in pharma be applied to non-product medical device software? In this article, we compare ISO 80002-2 with GAMP5 to find out.
In 2023, the IVD industry will continue to dominate the medical technology market due to rising demand for early diagnosis, treatment and point-of-care testing. Product trends include the accelerated consumerization of diagnostics, the rise of telemedicine and digital health, the growth of devices enabling personalized medicine and the emergence of AI and robotics-powered medical devices. Medical device manufacturing will undergo changes in the computerized system validation process due to the increased focus on critical thinking by GAMP5 and FDA.
In this article, you will learn a structured approach to ensure regulatory compliance and proper operation of your computer systems, throughout their life cycle.
December is often symbolized as the ‘Month of Giving’ as it revolves around giving something back to society, helping others and spreading joy. Supporting good causes is one way we put our company value ‘joy’ into practice at the QbD Group. Let’s highlight a few of them!
Artificial intelligence (AI) and machine learning (ML) are on the rise in the medical device and IVD industry. Learn more about the current landscape and regulatory framework here.
Learn more about the importance, benefits, and key challenges related to Annual Product Quality Review in Pharma.
Job fair season is upon us! Whether you’re looking for your first job or a new work adventure, we can all agree that applying for a job comes with a healthy dose of nerves. To make sure you are the best version of yourself, preparation is key! Want to succeed in your next interview and land your QbDream job in consulting? Put your foot in the door and kick it wide open with these 5 tips!
Bringing a Medical Device to market involves many hurdles, including design and development. In this blog post, you will learn more about the importance of Design Transfer and Process Validation in medical device development.
Today, on Nov. 14, 2022, we proudly received the Baanbrekende Werkgever ’23 certificate for the second year in a row, representing our commitment to put our employees at the center of our policies around hybrid work and mobility.
Digital health is on the rise, but what is digital health exactly? In this blog post, we’ll explore the landscape, key technology pillars and future opportunities.
21 CFR Part 11 regulates the use of electronic records and signatures in pharma and medical devices. Want to comply? Read more below and download our 21 CFR Part 11 compliance checklist.
Discover 5 reasons to engage with an experienced Contract Research Organization (CRO) specialized in medical device studies to support you in your clinical research.
It is important to understand how standards are written and how their references are constructed in order to properly reference them and purchase the correct version for your use.
In this blog entry, we explain the difference between ISO and IEC standards, what harmonized standards are, and how to use the appropriate standard references in your technical documentation. We also give you a hint on how to make sure you have identified all applicable standards for your products.
Want to learn more about the difference between Artificial Intelligence and Machine Learning and/or need insight into the right validation strategy for your AI- or ML-based systems and products? Read more here.
The quality of process gases and gas distribution networks is becoming increasingly important for biotech pharmaceutical processes and ATMP sites. In this blog, we highlight the importance of a qualified process gas and distribution network, even at an early stage of development.
Self-inspections or internal audits are an essential part of your QMS. In addition to determining whether your QMS meets guidelines and standards, you can benefit from them in several ways. They allow you to get to know departments better, explain to people why certain quality processes are necessary, gather useful feedback for further improvements to the QMS, and you have a tool to check your readiness for external audits.
Are you a manufacturer of custom-made medical devices and in need of regulatory guidance? This article summarizes key concerns to consider.
In Belgium, medicine advertising is subject to legislation in order to ensure the rational use of medicines. Each firm must appoint a Responsible Person for Information and Publicity, who checks the conformity of the advertising.
The Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Device Regulation (IVDR) (EU) 2017/746 introduced a new mandatory role in Article 15: the Person Responsible for Regulatory Compliance or ‘PRRC’. Wondering what the meaning of the PRRC-role is and where you can find the right person? Then read on!
Compressed air and other process gases are used in a lot of different steps during pharmaceutical manufacturing. Some examples are the use of compressed air in direct contact with products to clean, aerate, or move them through the processes or the using process gases in fluid pumps that take products through the production and filling processes. Compressed gases, such as nitrogen or argon, can also be used for blanketing or to spray or coat a product. The risks associated with the use of these gases, depend on the amount and type of product contact and based on this risk assessment, a suitable monitoring plan should be in place.
At the QbD Group, we want to take into account the opinion of our employees. Therefore, our Board of Ambassadors was elected to represent the voice of all QbD’ers, within and outside of the group. Thomas Van Looy has been elected as one of our Ambassadors for 2022. Congratulations, Thomas! As an Ambassador, he loves to share his QbD Group experiences. Want to find out more about Thomas’ #QbDream job? Then don’t miss out on the interview below.
Sometimes it is necessary to perform data migration in computer systems, applications, or software. Learn more about the goal, importance and risks here.
At QbD, we value the opinion of our employees. Therefore, QbD’s Board of Ambassadors was formed to represent the voice of all QbD’ers, across the QbD Group and across all borders. Catarina Cruz has been elected as one of our Ambassadors for 2022. Congratulations! As an Ambassador, Catarina loves to share how she experiences working at QbD. Want to find out more about her #QbDream job? Make sure to read the interview below.
On August 21, 2022, the new GMP Annex 21 will enter into force. This Annex contains the GMP requirements for MIA holders when importing medicinal products from outside the EU/EEA. Learn more here.
To document the clinical evaluation of your device and its output, a Clinical Evaluation Report or CER has to be compiled. Learn more about this key document, its content, common gaps and hurdles.
During the pandemic, electronic signatures gained tremendous importance for companies in the regulated sector. Learn more about electronic signatures, their use and safety here.
The Clinical Evaluation Plan, or CEP, is a crucial starting point and guide for the clinical evaluation of your medical device. Learn more about this key document and its requirements.
Steven Vinkx has been working for QbD for 10 years now, and counting. Congratulations! Curious about his career and insights? Then be sure to read this interview!
Clinical evaluation of medical devices is critical to obtaining and maintaining marketing approval in the EU. Learn more about clinical evaluation here.
A certificate of suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is considered to replace the relevant sections in the application for marketing authorization demonstrating the quality of substances for pharmaceutical use. The inclusion of a CEP in an MAA simplifies the review process for authorities and the submission procedures for industry. However, with the upcoming changes to the EU pharmaceutical legislation, the CEP procedure may be at risk. In this blog post, we outline the possible changes in the near future.
CAR-T cell therapy uses genetically engineered T cells to destroy tumor cells. Learn more about the main components, manufacturing process and prospects of this promising immunotherapy.
Dominiek Rossillion has been working for QbD for 10 years now, and counting! Our heartiest congratulations! Curious about Dominiek’s career and insights? Then be sure to read this interview!
The new medical device regulations and the associated implementation of EUDAMED are intended to give the general public access to relevant information on medical devices, ensuring greater transparency. However, EUDAMED also brings new requirements for market participants throughout the life cycle of medical devices. Read more about them here!
GAMP categories are very important to decide on the validation strategy of your computerized system. Learn more about all categories here.
10 years! That’s how long Katrien Janssens has been working at QbD now. Congratulations! Curious to know how Katrien has experienced the past decade at QbD? During a brief interview, we asked her 10 quick questions: one for each year she has worked with us!
3D printing offers unrivaled flexibility and personalization in medical devices as illustrated by the case of Joe DiMeo’s face and hand transplant. Curious? Be sure to read on!
Regulatory Affairs plays a key role in the pharmaceutical industry: from drug development to commercialization. Learn more about the roles and functions that RA teams can provide in the lifecycle management of your pharmaceutical product.
Sampling, testing, and preserving your medicinal product in closed systems often present difficult Quality Control challenges. As part of the solution, various AI-based in-process controls can be used. Discover them here!
Cell therapy includes various ATMPs to fight tumors or restore the physiological status of damaged tissue. Explore them here.
If you know that QbD was founded 10 years ago, then it won’t come as a surprise to you that the 10Y anniversary of an employee is an EXTRA big deal to us. After QbD founder Bart (obviously), Jeroen Verhoeven is the very first employee to reach that landmark.
In order to give this news the attention it deserves, we fired 10 questions at Jeroen, one for each year he’s been with us!
On November 15, 2021, QbD and TRIUM received the Baanbrekende Werkgever ‘22 certificate for pioneering Belgian employers striving to put people at the center of their policies on hybrid work and mobility.
Dendritic cells play an important role in recently developed DC-based immunotherapies for the treatment of cancer, autoimmune diseases and the prevention of graft rejection. Read all about DC cells and their potential in this article.
NK cells, as part of our innate immune system, are very effective in killing different types of cells, including tumor cells. Because of these properties, they become very interesting as ATMPs for immunotherapy.
Curious about the potential of NK cells and NK-cell-based immunotherapy? Learn all about them here, including the benefits and challenges.
In the EU, the IVDR will replace the IVDD. The compliance deadline is approaching, so act now to obtain CE marking of your IVD medical device in time.
Follow these steps before launching medical device combination products in the EU, including the application of MDR Article 117 and the EMA Guidance.
Learn more about the new risk-based approach to in-vitro diagnostic device classification under IVDR 2017/746, replacing outdated directives.
Curious about the latest medical device industry trends? Learn more on wearables, AI, POC testing, IoT, and more in this blog post!
The QbD Academy is a young graduates program that combines working, learning and intensive training. Last month, we welcomed 15 young graduates during our QbD Academy Week. Read all about it here!
Artificial Intelligence is the IT word in Medical Devices nowadays. Learn more on AI and its regulatory implications for manufacturers.
The terms SaMD (Software as a Medical Device) and MDSW (Medical Device SoftWare) are often used interchangeably within medical environments, but they are not. Learn the difference in meaning and regulatory scope here.
Brexit impacts the medical device markets of Scotland, England, Wales and Northern Ireland. Learn more on the consequences for manufacturers that place medical devices on the UK market here.
ATMPs are a promising new type of medicine. Learn more about the challenges in translating the expertise into a GMP process.
Sports have always been an essential part of QbD and TRIUM’s DNA. So – to celebrate both our 10-year anniversaries – we came up with an exciting event combining all of these values: our 10Y International Sports Challenge! Read all about it here.
Whether your product is a medical device depends on the markets you want to enter and their regulations. Here’s an overview to guide you.
Risk management, the key to medical device safety, involves much more than ticking the FMEA box. Jeroen Verhoeven, one of our specialists in the matter, explains why and guides you through the ISO14971 standard (application of risk management to medical devices).
At QbD, we’re going the extra mile to put hybrid working to everyone’s advantage after COVID-19. Need some inspiration? Follow our lead!