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.
Jun 28, 2024, 9:00:00 AM | Discover the highlights from ValConnect 2024, showcasing cutting-edge technologies, customer success stories, and the unveiling of ValGenesis VLMS 5.0.
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.
Explore how ValGenesis VLMS 5.0 marked a key milestone in the evolution of digital validation lifecycle management, paving the way for today's iVal solution.
Learn how ValGenesis iCMC integrates Quality by Design principles with CMC lifecycle management to enhance pharmaceutical process development.
Revolutionize pharma operations with ValGenesis e-Logbook. Streamline data entry, enhance compliance, and drive efficiency in manufacturing processes.
Integrating risk assessment and continued process verification with digital technology enhances patient safety and optimizes processes in the pharma industry.
Discover the importance of real-time process monitoring in pharma manufacturing. Explore how RTM enhances efficiency, quality, and compliance.
Explore best practices for impact assessments in cleaning validation, including strategies for using technology to streamline the assessment process.
Explore how digital transformation in pharma manufacturing enables continuous process verification and data-driven quality insights for better APQRs.
ValGenesis e-Logbook uses business rules to enforce SOPs and standardize log activities, improving decision-making, productivity, and data integrity.
Learn how ISPE's GAMP 5 Guideline and the FDA's CSA Guidance play complementary roles in ensuring the integrity and reliability of computerized systems.
Discover why Excel is no longer sufficient for effective risk management in the pharma industry and why transitioning to specialized software is crucial.
Discover best practices for integrating your commissioning and qualification processes and how to streamline C&Q activities with robust digital solutions.
Learn best practices for implementing an integrated commissioning and qualification approach and the 5 critical elements to include in your C&Q plan.
Quality Risk Management
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
Tech Transfer & Process Scale-up
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
Catalent's Journey of Continuous Improvement for CSV Excellence
Are You Aligned with FDA's Computer Software Assurance Methodology?
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.
Explore how to establish defensible limits for dirty and clean hold times in cleaning validation to ensure compliance and product safety in pharmaceuticals.
Previously
Funding Cleaning Validation Before the Next Investigation
Cleaning Validation Limits Explained: HBEL/MACO, 10 ppm, and 'Visually Clean'
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.
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