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💡 Chemin de validation d'un système : de la définition des besoins à la validation finale ! 📊 Découvrez les étapes clés de notre processus de validation : VPM, URS, RTM, DQ, IQ, OQ, PQ et VSR. Chaque étape est cruciale pour garantir la qualité et la conformité de vos systèmes. #Validation #Système #Qualité #Conformité #GestionDeProjet #Ingénierie #Test #ValidationDesSystèmes #DOZLIFESCIENCES
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Connexio #hiringalert #catalogueoperations #quickcommercestartup #gurgaonlocation #productlistingexperience #productinformationmanagementtoolsexperience #cataloguemanagementsystems
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Discovering new paths by working together! At Carrier Mexico we make modern life possible by offering revolutionary systems and services that help homes, buildings and shipments become safer, smarter and more sustainable. We are seeking a Software QA Specialist to join our team, click the following link for more information ---->https://lnkd.in/g2WHfEPh Know someone perfect for the job? Tag them in the comments or share this post! #CarrierOpportunity #jobalert
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Un petit template qui peut vous servir si vous devez valider une méthode analytique 😉
📚 Analytical Test Method Validation/Verification 💡 Pre-Validation Requirements: 💡 ▶ Gather your tools and materials, ensuring they meet the highest standards of quality and #traceability. ▶ Verify the analytical system's design, maintenance, and #qualification to guarantee consistent performance. 💪 Specificity: 💪 ▶ Achieve unequivocal identification of your analyte, even in the presence of potential #impurities or matrix components. ▶ Employ identification and #purity tests to ensure accurate determination of impurities and content. 📏 Linearity and Range: 📏 ▶ Establish a #concentration range where your method delivers precise, accurate, and linear results. ▶ Verify that your method can handle samples within the expected #working range. 🎯 Accuracy and Precision: 🎯 ▶ Explore the accuracy and recovery studies to ensure your results are consistently within acceptable #limits. ▶ Assess #repeatability, within-day, and between-day precision to demonstrate the reliability of your method. 💪 Robustness: 💪 ▶ Test the resilience of your method against small variations in #parameters like flow rate, mobile phase composition, and injection volume. ▶ Ensure your method remains unaffected by these deliberate #changes, guaranteeing reliable performance. ✨ Limit of Detection & Quantitation: ✨ ▶ Determine the #lowest concentration at which your analyte can be detected and quantified with confidence. ▶ Calculate LOD and LOQ using standard #deviation and slope values. 👍 System Suitability: 👍 ▶ Perform system suitability tests to verify #reproducibility, efficiency, tailing, and resolution before analyzing unknown samples. ▶ Ensure your system meets predefined criteria for precision, #resolution, tailing factor, capacity factor, and theoretical plates. 📝 Observations and Deviations: 📝 ▶ Keep a watchful eye for any deviations from protocol #requirements and document them promptly. ▶ Investigate the causes, assess the impact on operations, and take corrective actions to maintain data #integrity. 📌 Analytical test method #validation is a cornerstone of scientific accuracy and precision. 👉 Follow Pharma Broadcast and Henry for more #Accuracy #Analytical #Validation #Verification #Precision #Research
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43 pages qui vous expliquent comment qualifier une chambre de maintien de température et /ou humidité. La norme française FD X 15 140, donne beaucoup de recommandations sur ce sujet aussi 😉 Merci Pharma Broadcast pour le partage 😊
💡 Stability Chambers 💡 🌟 Qualification: ▶ This process involves several stages, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). ▶ Periodic re-qualification is also conducted to maintain the integrity of the chambers over time. ⚙️ Calibration: ▶ Proper calibration of equipment used within stability chambers is crucial for accurate monitoring and control of temperature and humidity. ▶ Calibration should be performed regularly using certified tools and methods. 🧹 Maintenance: ▶ Regular maintenance is essential to keep stability chambers functioning optimally and prevent any potential issues. ▶ This includes periodical maintenance, technical support, microbiological monitoring, cleaning, and on-line monitoring. 🚨 Alarm Systems and Change Control: ▶ Stability chambers are equipped with alarm systems to monitor and alert for any deviations in temperature or humidity. ▶ A robust change control process is also in place to manage any modifications or changes to the chambers. ©Credit to Dr. Mathias Kramer @ Roche for this Succinct document 👍 👉Follow Pharma Broadcast for more #Pharmaceutical #Stability #Quality #Control #Qualification
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Los bancos de pruebas (bancos de pruebas) son componentes esenciales de la mayoría de los regímenes de pruebas de productos. Este breve artículo describe qué son los bancos de pruebas y su papel crucial en diversas industrias, por lo que podrá hacerlo. #DEWESoft #TeamDEWESoft #DAQ https://lnkd.in/eVirBJh6
Test benches (testbeds) are essential components of most product testing regimens. This short article describes what test benches are and their crucial role across diverse industries so you will be able to. #DEWESoftUSA #DEWESoft #TeamDEWESoft #DAQ https://lnkd.in/eVirBJh6
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La combo #Sealights, #Testim, #qTest et peut-être #Neoload peut faire mouche pour la #QA sur #DevOps. Pensez vous être dans le contrôle sur ces sujets ? Parlons-en
🥁🎉 We are excited to announce that Tricentis SeaLights has been selected as a finalist in the Best Testing Service/Tool category for the 🏆 2024 #DevOpsDozens Awards! We'd be honored if you could help cast your vote 🗳️ for Tricentis SeaLights: https://bit.ly/3OgtsAw (Voting ends December 31) #SeaLights #Testing #DevOps
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Our Diagnostics Division is looking for a Quality Auditor in Mexico. https://lnkd.in/gv-a3rXG
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