Paperless processes can revolutionize your pharma supply chain! 📄➡️💻 Paper-based systems plague the pharmaceutical industry with manual data entry, misplaced documents, and limited visibility into product history. 🤯 This translates to costly errors, incomplete data, and difficulty tracing product history, potentially leading to compliance violations, recalls, and production stoppages. 📉 Embrace the power of paperless quality systems: Accurate data capture: Digital forms and sensors capture data at the source, eliminating transcription errors and ensuring data integrity. 💯 Automated workflows: Streamline processes with automated workflows that eliminate manual tasks and improve efficiency. 🚀 End-to-end traceability: Gain real-time visibility into your entire supply chain, from raw materials to finished products, ensuring regulatory compliance and patient safety. 🔍 Reduced costs: Save time, resources, and money by eliminating paper-based processes and streamlining operations. 💰 Improved compliance: Ensure compliance with regulatory requirements and industry best practices. ✅ #pharma #supplychain #paperless #quality #efficiency #traceability #compliance #supplychainwizard Read more here 👇
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𝐌𝐄𝐃𝐕𝐀𝐂𝐎𝐍 𝐇𝐚𝐬 𝐚 𝐍𝐞𝐰 𝐁𝐥𝐨𝐠 𝐏𝐨𝐬𝐭 Transform Your Org Chart with #Lean Efficiency Learn how applying Lean #principles to your organizational chart #database can improve its design, #functionality, and #usability. ✅ #LeanDocuments Approach: Focus on essential information such as employee names, job titles, and reporting relationships. Simplify data entry by minimizing mandatory fields to reduce errors and save time. Standardize formatting for clarity and consistency. ✅#LeanConfiguration Approach: Customize fields to meet your organization's needs. Design a user-friendly interface with intuitive navigation and responsive design for easy access. Promote transparency by allowing employees to update their profiles and track changes. By embracing Lean principles, you can create a streamlined, efficient, and adaptable organizational chart that fosters clarity and communication. 𝐓𝐨𝐝𝐚𝐲’𝐬 𝐏𝐨𝐬𝐭: 𝐏𝐚𝐫𝐭 𝟓 𝐨𝐟 𝟖 – 𝐇𝐨𝐰 𝐋𝐞𝐚𝐧 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬 𝐂𝐚𝐧 𝐁𝐞 𝐀𝐩𝐩𝐥𝐢𝐞𝐝 𝐭𝐨 𝐚𝐧 𝐎𝐫𝐠𝐚𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐡𝐚𝐫𝐭 “Let's explore how lean principles can be applied to an organizational chart (Org Chart) database record to streamline its design and functionality while ensuring clarity and usability.” Come read the article now! https://lnkd.in/eUCWtAsD #discovery #lifescience #pharma #pharmaceutical #pharmaceuticals #biopharma #biopharmaceuticals #biopharmaceutical #biotech #biotechnology #biotechnologies #biotechindustry #biotechnologyindustry #pharmaceuticalindustry #pharmaceuticalmanufacturing #pharmaceuticalcompanies #pharmaceuticalresearch #pharmaceuticaltechnology #pharmaceuticalpackaging #pharmaceuticalsales #pharmaceuticaljobs #pharmaceuticalinnovation #pharmaceuticalsciences #biotechnologist #compliance #qualitycontrol #computersystemvalidation #cleaningvalidation #processvalidation #dataintegrity #technologytransfer #meddevice #medicaldevice #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicemanufacturing #medicaldevicesales #medicaldevicedevelopment #medicaldevicedesign #medicaldeviceresearch #laboratoryequipment #laboratories #laboratorymedicine #laboratoryservices #laboratoryprofessionals #capa #qualification #validationengineer #engineering #engineeringservices #engineeringsolutions #processengineering #processengineer #engineeringdesign #heretohelp #gettingthejobdone #gettingthingsdone
Understanding the regulatory updates for Aligning Quality System Regulations | P5
https://medvacon.com
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Read the blog below to learn how Dataworks transformed the manufacturing process of a large Multinational Medical Technology Company by significantly improving Efficiency, Quality and Compliance. #MedTech #PharmaceuticalIndustry #manufacturing https://bit.ly/3JkV05i
MES Works from Dataworks transforming Manufacturing
https://www.dataworks.ie
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Enabling Quality Compliance for the Life Science Organizations Part 3 – Records, Documents and Change Controls Visit my posts for part 1 & 2 This blog focuses on the second major quality function that life science companies must have in place: records, documents and change controls. Let’s look at how an organization can leverage PLM/QMS to maintain a secure central data and records management system. Not only are life science companies required to maintain a secure, comprehensive and centralized system for design, quality and manufacturing documents and procedures, but they are also required to be ready to identify all incidents impacting quality or resulting in product changes. This process must include detailed documentation. The FDA demands all of the above plus an easy way to track and retrieve all changes in support of Quality Systems Inspection Technique (QSIT) audit requirements*. PLM allows companies to streamline the process with instant and controlled access across product development, production and quality. Integrating with QMS will maintain quality compliance across all business units, standardize critical processes and develop detailed documentation storage as required by the FDA. The integration of a PLM/QMS system will allow organizations to: · Implement and maintain a comprehensive documentation and change control model, preserving data integrity · Keep one set of the correct data created by many functions to be accessed anytime and anywhere with role-based access · Facilitate regulatory submissions across international markets · Accelerate audit preparation · Realize lean product management by reducing cost of changes and providing instant visibility to the impact of change on the affected product and related data elements · Iterate safety measures and better decision making through cross-functional collaboration Consequently, the change process will be streamlined in many ways. For example, it can help identify impacted processes, parts and suppliers early on. It can also help keep the approval process lean by intelligently selecting approvers based on context during the change approval process, and it can provide workflows to track completion of the change during the implementation process. Leveraging advanced analytics and product lifecycle intelligence (PLI), companies can gain insights into the change process to describe how certain variables affect change performance, and to obtain descriptive, diagnostic, predictive and prescriptive data that will guide them to develop a compliant product that will meet regulatory requirements. PLM/QMS transforms records, documents and change controls process, providing an essential infrastructure for storing and sharing product data, managing change, ensuring authenticity and integrity of electronic records and ultimately, improving record reuse. *FDA 21 CFR Pts 11, 820.30, 820.40, 820.180 & ISO 14971-2007 #LifeScience #Pharma #Biotech #MedDev #PLM #QMS #ProjectManagement
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𝐌𝐄𝐃𝐕𝐀𝐂𝐎𝐍 𝐇𝐚𝐬 𝐚 𝐍𝐞𝐰 𝐁𝐥𝐨𝐠 𝐏𝐨𝐬𝐭 Transform Your Org Chart with #Lean Efficiency Learn how applying Lean #principles to your organizational chart #database can improve its design, #functionality, and #usability. ✅ #LeanDocuments Approach: Focus on essential information such as employee names, job titles, and reporting relationships. Simplify data entry by minimizing mandatory fields to reduce errors and save time. Standardize formatting for clarity and consistency. ✅#LeanConfiguration Approach: Customize fields to meet your organization's needs. Design a user-friendly interface with intuitive navigation and responsive design for easy access. Promote transparency by allowing employees to update their profiles and track changes. By embracing Lean principles, you can create a streamlined, efficient, and adaptable organizational chart that fosters clarity and communication. 𝐓𝐨𝐝𝐚𝐲’𝐬 𝐏𝐨𝐬𝐭: 𝐏𝐚𝐫𝐭 𝟓 𝐨𝐟 𝟖 – 𝐇𝐨𝐰 𝐋𝐞𝐚𝐧 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬 𝐂𝐚𝐧 𝐁𝐞 𝐀𝐩𝐩𝐥𝐢𝐞𝐝 𝐭𝐨 𝐚𝐧 𝐎𝐫𝐠𝐚𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐡𝐚𝐫𝐭 “Let's explore how lean principles can be applied to an organizational chart (Org Chart) database record to streamline its design and functionality while ensuring clarity and usability.” Come read the article now! https://lnkd.in/eUCWtAsD #discovery #lifescience #pharma #pharmaceutical #pharmaceuticals #biopharma #biopharmaceuticals #biopharmaceutical #biotech #biotechnology #biotechnologies #biotechindustry #biotechnologyindustry #pharmaceuticalindustry #pharmaceuticalmanufacturing #pharmaceuticalcompanies #pharmaceuticalresearch #pharmaceuticaltechnology #pharmaceuticalpackaging #pharmaceuticalsales #pharmaceuticaljobs #pharmaceuticalinnovation #pharmaceuticalsciences #biotechnologist #compliance #qualitycontrol #computersystemvalidation #cleaningvalidation #processvalidation #dataintegrity #technologytransfer #meddevice #medicaldevice #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicemanufacturing #medicaldevicesales #medicaldevicedevelopment #medicaldevicedesign #medicaldeviceresearch #laboratoryequipment #laboratories #laboratorymedicine #laboratoryservices #laboratoryprofessionals #capa #qualification #validationengineer #engineering #engineeringservices #engineeringsolutions #processengineering #processengineer #engineeringdesign #heretohelp #gettingthejobdone #gettingthingsdone
Understanding the regulatory updates for Aligning Quality System Regulations | P5
https://medvacon.com
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IP Asset Cataloging Techniques: Cataloging is not merely listing. A catalogue must give "intelligence" to the reader and not just "data". Cataloging your IP assets is about organizing your IP assets to understand their connections to the market, products, R&D pipeline, risks, and opportunities. The top management should be able to take important decisions by looking at the IP catalogue of your company. Effective IP cataloging can: - Enhanced Visibility - Informed R&D Strategies - Strategic Market Planning Some techniques for Powerful IP Cataloging: 1. Product based cataloging: Organize IP assets around specific products, highlighting their contribution to the final offering. 2. Market driven cataloging: Categorize IP by their relevance to specific market segments, prioritizing those with high commercial potential. 3. Tech area based cataloging: Group IP based on technological areas (e.g., drug delivery, formulation) assisting in the R&D and technology transfer strategies. By implementing a robust IP cataloging system, your company can unlock the true potential of its innovations, driving long-term success.
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Do you have challenges in real-time monitoring, quality control, and compliance in your pharmaceutical manufacturing? Our Smart Alert Solution Accelerator can help. It has Real-time Data Collection: Existing Data Loggers from Machines can be used used or Data loggers are strategically placed across critical production points to continuously collect real-time data on temperature, humidity, pressure, and other vital parameters. Intelligent Data Analysis: Leveraging advanced data analytics, the accelerator processes the incoming data, identifying patterns, trends, and anomalies that could potentially impact product quality or regulatory compliance. Threshold-based Alerts: The accelerator employs configurable thresholds to trigger real-time alerts and notifications when monitored parameters breach predefined limits. This facilitates immediate corrective actions. Compliance Monitoring: The accelerator ensures adherence to regulatory standards by continuously tracking and recording data related to critical manufacturing parameters. Deviations trigger alerts and enable rapid corrective measures. Customizable Dashboards: Intuitive and customizable dashboards offer real-time visualization of manufacturing conditions, enabling operators and managers to monitor key parameters at a glance. Contact us for more details Feel free to reach out to me just by writing YES in message Note: All trademarks, logos, and brand names are the property of their respective owners Ravindra Gadgil Kunal Pradhan Ashish Soni Ash Kulkarni MBA, MHA Rahul Agarwal Sagar Karmarkar Vilas Bendre Vilas Bendre Ashish Soni
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"This is going to make our lives so much easier." This is the reaction we got from Natasha Kanda, Head of Regulatory Affairs at Rodial. Why is Worldover able to do that better than anyone else? 1. A Product Lifecycle Management System designed specifically for beauty. Beauty brands and manufacturers have very individual needs which mean traditional PLM providers are not set up for their exact use cases. 2. Leveraging AI and automation. We use AI in our platform to automate a huge amount of tasks that were previously done manually. Checking formulations, chasing for documents, extracting information. This has moved from being done in days an and months to seconds. 3. Breeze through compliance, even as regulations and requirements change. We have built in checks against all global regulations, retailer lists and custom blacklists enabling compliance checks to be done immediately and on an ongoing basis as these regulations change. 4. Listen to our customers. Our platform has flexibility built in and this enables us to cater our platform to the specific needs of each customer. This gives them a workflow that matches their process exactly. If you are looking for a way to make your life easier then head here 👇 https://lnkd.in/eH2pHnZE Or if you want more info on us: https://www.worldover.io/
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"This is going to make our lives so much easier." This is the reaction we got from Natasha Kanda, Head of Regulatory Affairs at Rodial. Why is Worldover able to do that better than anyone else? 1. A Product Lifecycle Management System designed specifically for beauty. Beauty brands and manufacturers have very individual needs which mean traditional PLM providers are not set up for their exact use cases. 2. Leveraging AI and automation. We use AI in our platform to automate a huge amount of tasks that were previously done manually. Checking formulations, chasing for documents, extracting information. This has moved from being done in days an and months to seconds. 3. Breeze through compliance, even as regulations and requirements change. We have built in checks against all global regulations, retailer lists and custom blacklists enabling compliance checks to be done immediately and on an ongoing basis as these regulations change. 4. Listen to our customers. Our platform has flexibility built in and this enables us to cater our platform to the specific needs of each customer. This gives them a workflow that matches their process exactly. If you are looking for a way to make your life easier then head here 👇 https://lnkd.in/eH2pHnZE Or if you want more info on us: https://www.worldover.io/
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𝗜𝗴𝗻𝗶𝘁𝗶𝗻𝗴 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗶𝗻 𝗟𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: 𝗜𝗹𝗹𝘂𝗺𝗶𝗻𝗮𝘁𝗲 𝗬𝗼𝘂𝗿 𝗣𝗮𝘁𝗵 𝘁𝗼 𝗦𝘂𝗰𝗰𝗲𝘀𝘀! In the intricate realm of laboratory management, the choice of a Laboratory Information Management System (#LIS / #LIMS) is nothing short of alchemy. It's about transforming your laboratory operations into a symphony of precision and efficiency. But like any great endeavor, it begins with the right guidance, and that's where we come in. 🔦 𝗪𝗵𝘆 𝗚𝗿𝗼𝗽𝗲 𝗶𝗻 𝘁𝗵𝗲 𝗗𝗮𝗿𝗸 𝗪𝗵𝗲𝗻 𝗬𝗼𝘂 𝗖𝗮𝗻 𝗦𝗵𝗶𝗻𝗲 𝗮 𝗟𝗶𝗴𝗵𝘁? Imagine wandering through a labyrinth, searching for that elusive treasure, in this case, the perfect LIMS solution. You could follow the traditional path, a journey filled with pitfalls, or you could take the enlightened route. Our mission is to be your guiding lantern, casting a brilliant glow on the path ahead. 💡 𝗪𝗵𝘆 𝗶𝘀 𝗧𝗵𝗶𝘀 𝗤𝘂𝗲𝘀𝘁 𝗦𝗼 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁? Laboratories are the lifeblood of scientific progress. As a Laboratory Manager or #CIO, you are entrusted with the keys to innovation, quality, and compliance. The choice of a LIMS system isn't just about software; it's about empowering your laboratory to thrive, to leap forward into the future with confidence. 📊 𝗧𝗵𝗲 𝗔𝗿𝘁 𝗮𝗻𝗱 𝗦𝗰𝗶𝗲𝗻𝗰𝗲 𝗼𝗳 𝗟𝗜𝗠𝗦 𝗦𝗲𝗹𝗲𝗰𝘁𝗶𝗼𝗻: Selecting a LIMS system isn't a one-size-fits-all affair. It's a delicate dance between technology, process optimization, and organizational alignment. This is where the expertise of an Information Systems Analyst, specializing in LIMS systems, becomes your secret weapon. 🎯 𝐖𝐡𝐚𝐭 𝐂𝐢𝐭𝐫𝐢𝐧𝐞 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐁𝐫𝐢𝐧𝐠 𝐭𝐨 𝐘𝐨𝐮𝐫 𝐋𝐚𝐛𝐨𝐫𝐚𝐭𝐨𝐫𝐲'𝐬 𝐓𝐚𝐛𝐥𝐞: 𝐃𝐞𝐞𝐩 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠: We decode the essence of your laboratory, understanding your unique workflows, regulatory requirements, and long-term goals. 💼 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬: We bridge the gap between IT and laboratory teams, aligning technology with your business objectives. 🛠️ 𝐂𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧: We ensure the selected LIMS system seamlessly integrates with your existing systems, like pieces of a finely crafted puzzle. 🤝𝐈𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩: We walk hand-in-hand with you during the implementation process, ensuring a smooth transition and rapid ROI. 🔮 𝐔𝐧𝐥𝐨𝐜𝐤 𝐘𝐨𝐮𝐫 𝐋𝐚𝐛𝐨𝐫𝐚𝐭𝐨𝐫𝐲'𝐬 𝐏𝐨𝐭𝐞𝐧𝐭𝐢𝐚𝐥 - 𝐓𝐨𝐠𝐞𝐭𝐡𝐞𝐫. CITRINE Solutions LTD. goal is to illuminate your path, ensuring that the LIMS system you choose is not just a tool but a catalyst for your laboratory's success. 🌐 𝐂𝐨𝐧𝐧𝐞𝐜𝐭 𝐰𝐢𝐭𝐡 𝐔𝐬: Reach out to discover how our expertise can transform your laboratory into a powerhouse of innovation and precision. Contact Citrine Solutions: info@ctrn-s.com | +972-506302042 | *6232 #LaboratoryManagement #Innovation #Efficiency #LabOperations #InformationSystems #LabTech #LabOptimization #ScientificProgress
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Analytical Chemist with deep understanding in Chromatography, Spectroscopy, Mass Spectrometry, Data Analysis, and Laboratory Techniques | Enhancing Precision in Chemical Analysis | Rotaractor | pace fellow alumni
💡 This week was all things quality control. Here are some of the trends shaping the future of QC Fueled by technological advancements, we're witnessing a shift towards smarter, faster, and more efficient methods for ensuring product quality. One of the trends is the rate at which automation and robotic systems is on the rise.Automated sample preparation, handling, and analysis can significantly cut down the time required for QC processes. Some of the advantages include: ✔Increased efficacy where systems can operate continuosly and handle large volume of samples without fatigue. ✔Consistency and precision which ensure uniformity and reduces variability in test results. ✔Although initial investment is high, automation reduces long-term operational costs. Second is the digitalization through laboratory information management system. LIMS integrate various laboratory operations, from sample tracking to data analysis, ensuring that data is accurate, easily accessible, and compliant with regulatory standards.It's advantages include: ✔Data Integrity-Digital records are less prone to loss or tampering compared to paper-based systems. ✔Enhanced Collaboration-Data can be easily shared and accessed by different stakeholders, facilitating better collaboration. ✔Regulatory Compliance-Automated data recording helps in maintaining compliance with regulatory requirements. Third we have real-Time Monitoring(In-Line and At-Line Analysis) which involves integrating analytical instruments directly into the production line (in-line) or nearby (at-line) to provide immediate feedback on product quality. Techniques like Near-Infrared (NIR) spectroscopy and Raman spectroscopy are commonly used for real-time analysis. Its advantages are: ✔Immediate Feedback as real-time data allows for instant adjustments, reducing the risk of producing out-of-specification products. ✔Increased Efficiency. Continuous monitoring leads to faster decision-making and process optimization. ✔Reduced Waste. Early detection of issues minimizes material waste and production costs. Fourth is the Advanced Data Analytics.The use of advanced data analytics, including big data and machine learning (ML), is becoming increasingly prevalent in QC. These technologies analyze vast amounts of data to identify patterns, predict outcomes, and provide actionable insights. While some of these trends are still evolving, their impact is undeniable. By embracing these innovations, analytical labs can ensure they are well-positioned for the future of quality control. As these technologies continue to evolve, analytical laboratories will be better equipped to meet the growing demands of precision and speed in quality control. #futureofwork #analyticalchemistry #qualitycontrol #innovation #laboratory #science
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