octobre 14, 2024
QC lab hplc
Published by Harris Bui-Vandeput at octobre 14, 2024
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What is Quality Control (QC)

Quality Control (QC) is the department which ensures that the incoming materials, products, utilities and cleanrooms are of sufficient quality for their use. The importance of QC stems from the undeniable obligation to deliver quality product that guarantees patient safety. Therefore, the need of a QC department has been made compulsory by several regulations including the EudraLex’s guidelines for GMP and FDA’s 21 CFR.   As the name suggests, the quality of incoming material, products, cleanrooms and utilities is verified in […]
octobre 7, 2024
Root Cause A
Published by Harris Bui-Vandeput at octobre 7, 2024
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Analyse de cause racine

Dans l’industrie pharmaceutique, la qualité n’est pas seulement un objectif, c’est une exigence. Pour répondre aux normes élevées de sécurité et d’efficacité, les entreprises doivent continuellement traiter et résoudre les déviations, les défauts de produits ou les problèmes inattendus qui surviennent. C’est là qu’intervient l’analyse des causes racines (ACR), une approche structurée qui permet de découvrir la cause sous-jacente de ces problèmes. L’ACR est essentiel pour plusieurs raisons. Tout d’abord, elle protège la sécurité des patients. En identifiant la cause […]
septembre 24, 2024
Published by Joachim Nuyttens at septembre 24, 2024
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Can AI Chatbots Pass the GMP test? Insights for QA in Life Sciences

In this follow-up to our exploration of conversational AI, we dive deeper into the accuracy and effectiveness of popular AI chatbots like ChatGPT, Google Gemini, Meta AI, and Anthropic Claude when it comes to crucial QA tasks in Life Sciences. We put these AI tools to the test with tasks such as: While these chatbots show potential, particularly in tasks like pre-writing and document review, our evaluation found significant limitations—especially with fabricating information on GMP regulations. So, are AI tools […]
septembre 5, 2024
Published by Joachim Nuyttens at septembre 5, 2024
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Unlock the Power of Conversational AI in Life Sciences QA

In today’s fast-evolving Life Sciences sector, Quality Assurance (QA) Officers face increasing pressures to manage documentation, compliance, and operational processes. Could Conversational AI be a solution to enhance efficiency and accuracy? AI chatbots like ChatGPT, Microsoft Copilot, and Google’s Gemini are revolutionizing how professionals operate. These AI tools can assist in various ways, from summarizing complex regulatory documents to brainstorming solutions, editing reports, and even automating repetitive tasks. How Can Conversational AI Help Your QA Team? However, while AI offers […]
février 9, 2023
Published by Joachim Nuyttens at février 9, 2023
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From lab to life: AI trends in the Life Science industry

by Tom Oostvogels, Jr. Consultant at Trevalco Artificial Intelligence (AI) is all around us nowadays and it is starting to transform industries in all sectors. As such, AI is also finding its way to the life science industry and will help healthcare as we know it. The incorporation of Artificial Intelligence in life sciences has opened doors to new possibilities and has created new opportunities for innovation and growth. In this post, we’ll explore 5 of the latest trends in […]
novembre 16, 2022
Published by Joachim Nuyttens at novembre 16, 2022
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Trevalco Academy – online training

Our brand new Trevalco Academy is now live, offering online courses in validation, quality assurance and GMP compliance for the pharmaceutical industry. Trevalco Academy is our online training center through which anyone can subscribe to and follow digital, self-paced courses. We currently have 4 online trainings to offer, including two one-day trainings: We want to offer qualitative training at a reasonable price, which is possible because this is all training material we used at clients and for training of our […]
septembre 21, 2022
Published by Joachim Nuyttens at septembre 21, 2022
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What’s in the new Eudralex Annex 1

A few weeks back the new and final version of Eudralex Volume 4 Annex 1 “Manufacture of Sterile Medicinal Products” was published on the website of the European Commission. This new version will come into operation on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. Where the current version of Eudralex Volume 4 Annex 1 is 16 pages, the new version has no less than 59 pages. The new EU annex 1 regulation provides […]
novembre 16, 2021
Published by Joachim Nuyttens at novembre 16, 2021
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How to get more value from risk assessments in the life sciences industry

If you’re working in the life sciences industry you have probably been involved in risk assessments, maybe more often than you would have liked to. Whether you are working in a clinical development or pharmaceutical production environment, on drug products or medical devices, risk management has to be in place. This article will give you tips to make your risk assessments even better. One of the main reasons why risk assessments are so omnipresent is because in most cases they […]
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