ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences
ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.
Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.
Sep 12, 2024 10:14:00 AM | Transform pharma manufacturing with digital control strategies. Learn how to enhance product quality, streamline processes, and ensure regulatory compliance.
Transform pharma manufacturing with digital control strategies. Learn how to enhance product quality, streamline processes, and ensure regulatory compliance.
Learn to avoid FDA 483 observations in cleaning validation to ensure patient safety and product efficacy. Protect your business with these actionable strategies.
Learn how traditional CSV conflicts with Agile development principles and why computer software assurance (CSA) is a better fit for Agile environments.
Discover how digital tools simplify tech transfer in Pharma 4.0, enhancing efficiency, product quality, and speed to market in the pharmaceutical industry.
See how ValGenesis iRisk transforms pharmaceutical development by integrating QbD and AQbD, streamlining processes, improving quality, and expediting approvals.
As life sciences companies work to ensure the quality and safety of their software systems, it's essential to understand the true intentions and uses of CSA.
Learn about the benefits and impact of transitioning to digital C&Q solutions for enhanced efficiency, compliance, and innovation in a Pharma 4.0 world.
Learn to enhance Product Quality Reviews (PQRs) with digital solutions that drive quality improvement and regulatory compliance in pharma manufacturing.
This case study highlights the transformative impact of VLMS technology to modernize equipment qualification processes and drive operational excellence at NEXA.
Quality risk management software ensures compliance with ICH Q9(R1) guidelines, enhancing risk assessments, decision-making, and product safety in pharma.
Discover the highlights from ValConnect 2024, showcasing cutting-edge technologies, customer success stories, and the unveiling of ValGenesis VLMS 5.0.
Explore the benefits of computer software assurance for software validation in life sciences. Learn how digital tools address common fears of CSA adoption.
Machine learning (ML) is transforming early-phase drug screening, enhancing efficiency and predictive accuracy. Learn how to apply it to your R&D process.
ValGenesis 5.0 delivers a next-generation user experience through redesigned workflows, speed enhancements, a modern UI, and AI-powered productivity.
Learn how ValGenesis iCMC integrates Quality by Design principles with CMC lifecycle management to enhance pharmaceutical process development.
Root-Cause Analysis
Finding the Root Cause in mAB Production: a ValGenesis Story
Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.
Written by
Sofia Santos
Process Digitalization
How to Accelerate Process Scale-Up With Effective Tech Transfer
There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.
Written by
Sofia Santos
Cleaning Validation
Risk-Based Cleaning Validation: A Lifecycle Approach
Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.
Written by
Kenneth Pierce
CSA flips the paradigm of traditional CSV to "right-size" validation processes. Learn more about the benefits and principles of the CSA approach, which encourages critical thinking and automation.
ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.
Previously
The Benefits of Automating Your Requirements Traceability Matrix
Catalent's Journey of Continuous Improvement for CSV Excellence
Learn how digitization offers a consistent way to carry out cleaning validation lifecycle activities, ensuring your methods and procedures are risk-based and rooted in scientific evidence.
Discover how fully digitalized cleaning validation boosts efficiency, ensures compliance, and transforms operational capacity in pharmaceutical manufacturing.
Previously
The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks
Digital Cleaning Validation: From Lifecycle Control to Real-Time Assurance
Waves of new technology and thinking — IoT, AR, cloud, Agile — are transforming the very foundation of validation processes. Learn how to leverage them in a Pharma 4.0 world.
Discover how fully digitalized cleaning validation boosts efficiency, ensures compliance, and transforms operational capacity in pharmaceutical manufacturing.
Previously
Catalent's Journey of Continuous Improvement for CSV Excellence
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