#1 mistake in pharma’s operational excellence revealed. Watch full video - https://lnkd.in/gFrPJnre Gresh Kumar, Head of Operational Excellence at Syngene, joins Vivek Gera in an interesting discussion emphasizing the vital role of operational excellence in pharmaceutical operations. Out of many pointers in the discussion, these were few: ? Foundation, not an add-on: Operational excellence should be integral, not peripheral. ? Enhances all phases: From R&D to quality assurance, every segment benefits. ? Speed and safety: Improved efficiency leads to faster, safer drug delivery to patients. Operational excellence isn't just about cutting costs; it's about building a more effective, agile, and responsive organization. How does your organization integrate these principles? Join the discussion below in the comments section
Leucine - AI for Pharma
制药业
Leveraging AI to deliver safer medicine to patients across the world by making compliance seamless for pharma companies
关于我们
Leucine is an AI-powered platform that helps pharmaceutical manufacturers in staying compliant and audit-ready while ensuring their medicines reach the patients faster. Using Leucine, Manufacturing, QA, and QC teams can significantly increase productivity and reduce deviations from cGMP guidelines across thousands of complex regulated workflows from material receipt to batch release. Leucine supports manufacturers across all modalities such as small molecules, biologics, gene therapies, vaccines etc. We have built industry's first AI framework, Leucine10x, which is designed to serve as a co-pilot in pharmaceutical manufacturing processes. Built on proprietary LLM technology, Leucine 10X offers an army of AI co-pilots that perform highly specialized tasks such as digitizing paper-based SOPs, creating a digital twin of the shop floor, collaborating with Production Managers in creating dynamic production plans, thus ensuring on-time batch delivery. Most significant is its ability to speed up Root Cause Analysis (RCA) of deviations in the manufacturing process by quickly analyzing data, including text-based records, logs, and even staff interview transcripts, to identify potential issues or patterns that might not be readily apparent. Leucine is currently deployed at over 30 companies in over 300 pharma manufacturing facilities across 10 countries, including the US, India, Brazil, Mexico, UAE, and others. Our customers trust us in helping them deliver safe medicine in the hands of the patients across the world. For more information visit: https://www.leucine.io
- 网站
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https://www.leucine.io
Leucine - AI for Pharma的外部链接
- 所属行业
- 制药业
- 规模
- 51-200 人
- 总部
- New York
- 类型
- 私人持股
- 创立
- 2019
- 领域
- 21 CFR Part -11 、EU GMP Annex-11、Data Integrity、FDA Validation、Artificial Intelligence、Machine Learning、GMP Compliance、Drug Product Quality、Quality Metrics、Manufacturing Execution System、Batch Planning、QC Planning、Investigations、Process Validation、Cleaning Validation、Product Changeover、Health-based Exposure Limits、Generative AI、Batch Execution、LLM和Batch Manufacturing Record
地点
Leucine - AI for Pharma员工
动态
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Is OEE the biggest illusion in pharma manufacturing? ?? (Why OEE might be misleading you about your true performance) We’ve all been there. OEE is the go-to metric for efficiency. At Leucine - AI for Pharma, we measure it religiously for our pharma customers. But what if it’s not telling you the whole story? ?? Here’s the issue: 1?? It’s a Composite Metric: OEE combines Availability, Performance, and Quality. Sounds great, right? But that’s also the problem — it doesn’t give you a clear view of what’s actually happening. 2?? It Lacks Granularity: Your OEE drops. But is it downtime? Slow cycle times? Defects? You’re left with questions and no clear direction. 3?? False Confidence: A high OEE can trick you into thinking everything’s fine. But it might be hiding serious problems in one of the core areas. Performance looks good? Sure. But if Availability is low, you’re not as efficient as you think. ? A Better Way Forward: ? Separate the Metrics: Track Availability, Performance, and Quality individually. Now you’ll know exactly where the problem is. ? Outcome-Focused Metrics: Look at throughput, lead time, and first-pass yield. These give you a direct view of your performance. ? Context is Everything: OEE can be useful. But don’t stop there. Always dive deeper into the details. The Takeaway: OEE is just one piece of the puzzle. Focus on what truly matters to get a clearer picture. - - -? ?? How do you measure what matters?
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Are we making medicines, or are we making paper? ?? (The untapped potential of MES in reducing pharma’s documentation burden) The pharmaceutical industry is drowning in paperwork. Every batch record, every compliance document, adds layers of complexity—and risks—to our operations. As Vilas Dholye highlighted in a recent chat with me, the documentation overload isn’t just inefficient; it’s a liability. The Challenge: ?? Mountains of paperwork increase the chances of errors and data integrity issues. ?? Manual documentation is time-consuming, pulling focus away from critical tasks. ?? Paper records are prone to mistakes, leading to costly deviations and regulatory scrutiny. The Opportunity: ?? Implement MES to shift from manual, paper-based processes to automated, digital workflows. ?? Enhance data integrity by capturing records in real-time, reducing the risk of errors. ?? Free up valuable time and resources to focus on what truly matters—producing high-quality medicines. Actionable Takeaways: Go digital: Start transitioning from paper to electronic records to boost efficiency. Prioritize data integrity: Use MES to capture data accurately and in real-time. Focus on value: Redirect resources from documentation to core manufacturing and quality activities. ?? What steps is your organization taking to reduce its reliance on paper? Let’s discuss how digital transformation can enhance both quality and compliance.
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Can paperless manufacturing solve Pharma’s biggest challenges? Vilas Dholye unveils the challenges and benefits of pioneering MES and paperless manufacturing in Pharmaceutical industry. Follow Leucine - AI for Pharma on LinkedIn and be part of tomorrow's insightful conversation! Click on the link to follow: https://buff.ly/3VLJW8N
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Struggling with MES implementation at your pharma facility? Meet Vilas Dholye, a trailblazer in MES implementation in Indian pharma, in a conversation with Vivek Gera. Here's how he transformed an industry and what you can learn from his journey. Vilas Dholye started his journey in the pharmaceutical sector after years in non-pharma, noticing significant gaps in technology adoption. His drive to eliminate the inefficiencies of paper-based processes led him to champion the first MES implementation in an Indian pharma company. Vilas's story highlights that even mid-sized companies can overcome cost and infrastructure hurdles by focusing on the long-term benefits of MES, such as enhanced data integrity and reduced variability. Ultimately, MES implementation is about future-proofing your operations and achieving excellence in quality and compliance. Watch Full Video - https://lnkd.in/guM8eUnW #pharma #pharmamanufacturing #fda #MES #Leucine
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Can paperless manufacturing solve Pharma’s biggest challenges? Vilas Dholye unveils the challenges and benefits of pioneering MES and paperless manufacturing in Pharmaceutical industry. Follow Leucine - AI for Pharma on LinkedIn and be part of tomorrow's insightful conversation! Click on the link to follow: https://buff.ly/3VLJW8N
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We were absolutely honoured to partner with Indian Pharmaceutical Alliance to bring to life the 9th Global Pharma Quality Summit last week. Prasad G V (Co-Chairman, Dr. Reddy's Laboratories), Dilip Shanghvi (MD, Sun Pharmaceuticals), Dr. Ranjana Pathak (CIO, Lupin), Prashant Sharma (CTO, Zydus Group), Phani Mitra B (Global CIO, Dr. Reddy's Laboratories), Reem Malki (CQO, Sun Pharmaceuticals), Sasikanth Dola (Partner, McKinsey & Company) and many other eminent leaders from the pharma industry shared their invaluable insights and perspectives on the future of pharma quality. We look forward to continuing these important conversations and working hard to drive progress and innovation in the pharma industry. #PharmaQuality #GlobalPharmaSummit #Innovation #Collaboration #HealthcareExcellence #PharmaceuticalIndustry #QualityManagement #FutureOfPharma
Had a fantastic experience at the Indian Pharmaceutical Alliance event! Learned so much and had the privilege of meeting some truly eminent personalities and industry leaders. Thanks to everyone who made it such a valuable and insightful event! Thank you for your great insights Shirish G Belapure Dr. Ranjana Pathak, @KrishnaVenkatesh Dr Rajiv Desai Prashant Sharma Dheeraj Sinha Sreeji Gopinathan Karan Rajendra Khairnar Kellia Hicks Thank you Jenil Dedhia Parth A. Karan Yerawar Sampada Bhootna Abhinav Singh Vivek Gera Mustaq Singh Bijral Anubhav Khanduja for your support.
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We were absolutely honoured to partner with Indian Pharmaceutical Alliance to bring to life the 9th Global Pharma Quality Summit last week. Prasad G V (Co-Chairman, Dr. Reddy's Laboratories), Dilip Shanghvi (MD, Sun Pharmaceuticals), Dr. Ranjana Pathak (CIO, Lupin), Prashant Sharma (CTO, Zydus Group), Phani Mitra B (Global CIO, Dr. Reddy's Laboratories), Reem Malki (CQO, Sun Pharmaceuticals), Sasikanth Dola (Partner, McKinsey & Company) and many other eminent leaders from the pharma industry shared their invaluable insights and perspectives on the future of pharma quality. We look forward to continuing these important conversations and working hard to drive progress and innovation in the pharma industry. #PharmaQuality #GlobalPharmaSummit #Innovation #Collaboration #HealthcareExcellence #PharmaceuticalIndustry #QualityManagement #FutureOfPharma
Had a fantastic experience at the Indian Pharmaceutical Alliance event! Learned so much and had the privilege of meeting some truly eminent personalities and industry leaders. Thanks to everyone who made it such a valuable and insightful event! Thank you for your great insights Shirish G Belapure Dr. Ranjana Pathak, @KrishnaVenkatesh Dr Rajiv Desai Prashant Sharma Dheeraj Sinha Sreeji Gopinathan Karan Rajendra Khairnar Kellia Hicks Thank you Jenil Dedhia Parth A. Karan Yerawar Sampada Bhootna Abhinav Singh Vivek Gera Mustaq Singh Bijral Anubhav Khanduja for your support.
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