🔊 𝐍𝐨𝐰 𝐩𝐥𝐚𝐲𝐢𝐧𝐠: "𝐏𝐨𝐝𝐜𝐚𝐬𝐭: 𝐀𝐈 𝐢𝐧 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭" - In this podcast episode Chantal van Gorp and Josh Keliher dive into the use cases, the challenges you'll face, and the considerations you must be aware of before you start embracing AI in your Quality Management. Start listening: https://lnkd.in/eKCtE3up #QMS #QA #AI #QualityAssurance Ennov
ION Pharma
Geneesmiddelenproductie
Vlijmen, North Brabant 595 volgers
Project management, system implementations and data services for the Life Science Industry
Over ons
ION Pharma is a Netherlands based service provider in the GxP domain. We stand for the implementation of, and data services for GxP information systems in the pharmaceutical industry. Our drive is to ensure availability of correct, complete, and compliant information, in the right format, to the users that need to have it when they need to have it. We make a difference in the following areas: - Program Management & Project Delivery - Due Diligence & Assessments - System Implementation & Validation - System & Data Migration - Data Analytics & AI As a licensed Ennov partner both implement and perform related data activities for the following GxP systems: - Quality Management System (QMS) - Document Management System (DMS) - Learning Management System (LMS) - Regulatory Information Management System (RIMS) - Validation Management System (VMS)
- Website
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https://www.IONPharma.nl
Externe link voor ION Pharma
- Branche
- Geneesmiddelenproductie
- Bedrijfsgrootte
- 2-10 medewerkers
- Hoofdkantoor
- Vlijmen, North Brabant
- Type
- Particuliere onderneming
- Opgericht
- 2021
- Specialismen
- Quality Assurance, Data Extraction, Computer System Validation, Computer Software Assurance, QA Managed Services, Quality Management Software, RIMS, Regulatory Information Management, Regulatory Affairs, Regulatory Operations, Program Management en Project Delivery
Locaties
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Primair
Achterstraat 27
Vlijmen, North Brabant 5251 CS, NL
Medewerkers van ION Pharma
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Stijn van den Berkmortel
Life Sciences Marketeer 🖥️ | GxP System implementation, Data Services & Project Management
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Jip Haen
Junior Consultant in Life Sciences at ION Pharma | MSc. Biomedical Engineering
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Chantal van Gorp
Managing QA Consultant for Life Science | GxP, ISO9001 and QMS are my sweet-spots | Pragmatic and Efficient | Quality starts with me!
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Chantal van Gorp
Manging Consultant at ION Pharma
Updates
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A warm welcome to Jip Haen, who is strengthening the ION Pharma team as Junior Consultant. 🎉 With his broad background in Biomedical Engineering as well as his experiences from chemical biology and molecular physiology research studies he brings a fresh perspective to the team. 🧬 Welcome to #TeamIONPharma, Jip!
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We are happy to receive these positive words on our work from a current project! 🚀 “You are #RIM Superman and RIM Metropolis needs you.” shared by the IT Global Project Manager of a leading generics manufacturer. These words are addressed to the project manager of our project team that is currently working on the implementation of a #RIMS solution. Does your RIMS project also require a RIMS Superhero? Get in touch 👉 https://lnkd.in/eJCVyPRq #RegulatoryAffairs #RA #LifeSciences
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Last Friday we've again sponsored and visited Benelux's largest student soccer tournament, la Copa de Maastricht, to meet with young talents. Where the last couple of years we've adopted the iconic pink church, this year we've taken it to the next level with the UFO stage! 🛸 For us this symbolizes our applied intelligence based on real experiences during projects instead of endless what-if's. For some it might sound like science fiction, but to us it's reality. And how to visualize this better than with a futuristic spacecraft! Are you ready to take your career to new heights? 🚀 Check out our open vacancies: https://ionpharma.nl/jobs/
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How do you successfully execute your #eQMS Implementation project in 8 clear steps? This is how! 👇 Read more on these steps, valuable tips, and pitfalls commonly occurring throughout the implementation process and how to prevent them. 📄 Download your free copy: https://lnkd.in/ewugFppR #QMS #QA #QualityAssurance #pharmaceuticals #lifesciences
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You are almost done with your #eQMS Implementation, but you need to sign off these 3 things first! 👇 (And they also apply to other systems, f.e. RIMS, DMS or LMS) 1. Approved and effective policy, procedures, instructions and manuals are in place 2. Make sure your Business Admins are properly trained by the vendor 3. Is User Training in place? Because user acceptance starts with on-the-job training by knowledgeable trainers Do you have additions to the list? Share your thoughts in the comments! #QMS #QualityAssurance #pharmaceuticals #lifesciences
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Your computer systems are #validated, so now it is a matter of copy and paste to migrate your #data! Or isn't it? 📦 Where it looks like a simple copy-paste would do the trick, data migration is way more than just moving all data from one place to another. As a best practice we approach the data migration process from a series of 6 phases: Assess, Plan, Extract, Cleanse, Load, and Verify. 👉 See the attached document for a series of tips per phase of the data migration process. #eQMS #QMS #QualityAssurance #lifesciences
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What brings together #AI, Quality Management, improving Patient Safety and even reducing costs? 🧬 It starts with embracing a Single Source of Truth. What do Chantal van Gorp and Josh Keliher think about this? Find out in the podcast episode 'AI in Quality Management': https://lnkd.in/eY9rEQiv #LifeSciences #QA #QualityAssurance
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How do you make sure your #eQMS does what it should? That's where Computer System Validation (#CSV) and Computer Software Assurance (#CSA) come in! A well-designed validation process uses a risk-based approach to determine the system's areas with the highest risk. These focus areas will be validated to ensure minimal impact on Patient Safety, Data Integrity and Product Quality without making any concessions on quality. 🗎 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝: 𝐂𝐒𝐕 𝐝𝐞𝐥𝐢𝐯𝐞𝐫𝐚𝐛𝐥𝐞𝐬 𝐚𝐧𝐝 𝐯𝐢𝐬𝐮𝐚𝐥𝐢𝐳𝐞𝐝 𝐢𝐧𝐭𝐞𝐫𝐫𝐞𝐥𝐚𝐭𝐢𝐨𝐧𝐬𝐡𝐢𝐩𝐬 To get you started we've summarized all deliverables during the CSV phase as well as their interrelationships: https://lnkd.in/e9QGsNHM #eQMS #QMS #QualityAssurance #lifesciences #GAMP #GAMP5 #GxP
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Selecting the right #eQMS vendor is straightforward? Think again. Choosing the right vendor isn't just about meeting your current needs but about ensuring flexibility for the future. That's why a vendor selection process involves detailed research, clear communication of defined requirements, and a thorough evaluation of proposals and demonstrations. 🔍 𝐀𝐯𝐨𝐢𝐝𝐢𝐧𝐠 𝐕𝐞𝐧𝐝𝐨𝐫 𝐋𝐨𝐜𝐤-𝐈𝐧: Selecting the wrong vendor can lead to a costly and restrictive vendor lock-in. Learn more about these dangers in our article 'Preventing Vendor Lock-In – Better Safe than Sorry': https://lnkd.in/emZUS3x8 Are you looking for support in your vendor selection? See our Due Diligence & Assessment services for more information: https://lnkd.in/dzpgyJbM #QA #QualityAssurance #Pharmaceuticals #LifeSciences #QMS