Business Process Management
PRODUCTS
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Our team of experts are equipped to guide you through every step of any Inspection, especially Pre-Approval Inspections, due to the nature of their criticality.
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Selecting a manufacturing partner who can manage all aspects of your product development lifecycle and associated supply chain is essential to improve efficiency and product quality.
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PHCbi brand’s LabSVIFT® IoT lab management solution is designed to provide real-time visibility and control of laboratory equipment and environments across single or multiple facilities. This cloud-based platform enables centralized monitoring, customizable alerts, and secure data access via a web-based dashboard. The new health check* function continuously evaluates equipment performance, identifies irregularities, and provides recommended corrective actions to maintain optimal operation. The system supports FDA 21 CFR Part 11 compliance and is compatible with select PHCbi and third-party devices. *health check function compatibility varies by model
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Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?
Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.
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Co-invented by Applied StemCell’s President and Chief Scientific Officer, Ruby Tsai, Ph.D., and Head of R&D, Alfonso Farruggio, Ph.D., TARGATT™ large knock-in technology enables rapid, efficient, and precise integration of large DNA fragments—up to 20 kb in a single reaction, more in nested reactions—into a specific intergenic locus.
WHITE PAPERS AND CASE STUDIES
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The Business Case For Pharmaceutical Continuous Manufacturing
Examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
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Elevating Downstream Process Development With Real-Time Data Monitoring
Learn how real-time monitoring with PAT enhances process control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.
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Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators
Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
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The Importance Of Understanding Materials In Medical Product Development
Explore considerations for the series of characterizations necessary to ensure the efficacy of a packaging or device component and final drug delivery system.
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Oligonucleotide Synthesis: Scale-Up Made Simple
Scaling oligonucleotide synthesis isn't as straightforward as it seems. Explore key challenges, critical process parameters, and solutions for a smooth scale-up.
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Mastering Ethylene Oxide Sterilization: Your Comprehensive Field Guide
Whether you're refining existing protocols or developing new ones, this guide serves as a valuable resource for ensuring safe, effective, and compliant sterilization outcomes.
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Enabling Digital Twins With Computational Fluid Dynamics Modeling
Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.
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Streamlining AAV And LVV Manufacturing Platform Solutions
Observe how streamlined, scalable platforms are transforming viral vector manufacturing to accelerate the delivery of cell and gene therapies to patients.
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Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing
For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.
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Driving Customer Profitability With Enterprise Platform, Pricing
Explore how the solutions and approaches offered by CDS can help different research stakeholders conduct more cost-efficient clinical trials in the industry's pharmaceutical, biotech, and device sectors.
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Digital Transformation - The Power Of Your Data
Discover how you can circumvent numerous recirculations during the ultrafiltration process step, boost downstream bioprocess yield, and identify and resolve process inefficiencies.
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An Introduction To MES For Cell And Gene Therapy Manufacturers
What are manufacturing execution systems, and why are they so crucial for cell and gene therapy manufacturing?
NEWS
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Xeneta And Keelvar Look To Revolutionize Freight Procurement With Real-Time Benchmarking And Sourcing Optimization7/5/2024
Xeneta, the premier provider of ocean and air freight rate benchmarking and market analytics, together with Keelvar, a leader in intelligent sourcing optimization and automation, have announced an integration that is set to transform supply chain procurement
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nShift: Belgian Companies Must Act Fast To Meet Minimum Delivery Options Requirements9/5/2024
Belgium’s online retailers have just 16 days to comply with a new legal requirement to provide their customers with greater delivery choice.
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Measurement Technology For Efficient Process Optimization And Quality Assurance In Medical Technology5/27/2025
At automatica 2025 (June 24 to 27 in Munich, Germany), Kistler will be presenting a broad product portfolio for automated manufacturing processes – or those on the way to being automated –at booth 205 in hall B5.
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KBC Launches Maximus 7.6 To Close The Gap Between Models And Upstream Operations9/23/2025
KBC (A Yokogawa Company) announces the launch of Maximus 7.6, a leading modeling and flow assurance platform for upstream oil and gas operations.
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Qualcomm And Honeywell Work To Revolutionize The Energy Sector With 5G, Low Power Wireless And Artificial Intelligence-Enabled Solutions11/26/2024
Qualcomm Technologies, Inc. and Honeywell announced an expanded collaboration to develop artificial intelligence (AI)-powered intelligent solutions for the energy sector.