INSIGHTS ON REGULATORY COMPLIANCE
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Driving Efficiency Through Process Intensification
Discover how intensification strategies reduce costs and waste while boosting throughput, sustainability, and operational value, which offers a smarter, more scalable approach to manufacturing.
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Uncovering Blind Spots In Environmental Monitoring
Discover how modern strategies like the Contamination Control Strategy are transforming environmental monitoring by exposing hidden risks, enhancing data quality, and unlocking deeper insights through innovative microbial methods.
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How Digital Cleaning Validation Can Simplify Audit Readiness And Improve Compliance
Discover how to enhance audit readiness and improve compliance by shifting to a digital cleaning validation program. Learn to determine worst-case products and maximum safe carryover limits.
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Removing The Headache: Outsourced Stability Storage And Testing Solutions
Should you manage certain operations internally or partner with a trusted external provider? Watch experts discuss the benefits of outsourcing stability, storage, and testing.
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Control Strategies And Method Development For Nitrosamines In Peptide APIs And Drug Products11/26/2024
Pharmaceutical scientists and engineers must advance robust, sensitive, and efficient nitrosamine detection and control methods to ensure regulatory compliance and safeguard public health in peptide-based drugs.
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Advancing Cell Therapy Manufacturing: Rapid Sterility Testing5/7/2024
The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.
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Why And Where To Monitor In Aseptic Processing Areas4/24/2025
Annex 1 mandates a risk assessment to identify optimal sample point locations. Explore factors in risk assessment, equipment selection, and system design to maximize data value.
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Combination Products: Navigating Regulatory Strategy, Design Verification5/19/2025
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
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Three Key Strategies To Guide Efficient And Effective Recall Management2/18/2025
Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.
REGULATORY COMPLIANCE SOLUTIONS
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Explore a system that delivers real-time, compliance-ready analytics, which empowers teams with self-service dashboards, embedded reporting, and actionable calibration and maintenance data.
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Use a real-time PCR (qPCR) solution for testing cell therapy products that provides sterility results in less than 5 hours.
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MasterControl’s eCTD submission and product registration management software automates, simplifies and accelerates submissions and product registrations.
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SoftMax® Pro Software - The most published microplate reader control and data analysis software
Preconfigured protocols and custom assay workflows simplify microplate data acquisition and analysis
SoftMax® Pro Software for Windows 10 is designed to provide the simplicity, flexibility and power required for advanced data analysis. It provides ready-to-run protocols, analysis algorithms, and 21 different curve fit options. Every step is optimized for data acquired from a Molecular Devices microplate reader or data imported from another source to simplify analysis and reporting. Compliance tools are available for regulated laboratories providing end-to-end chain of custody.
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A lot of companies see quality management as a process that puts the brakes on progress. We’re here to change that. MasterControl QMS software will help you digitize and automate every step of quality management. We’ll help you eliminate the hassles, inefficiencies, and paper of your current system. Then you can get your products to market faster.