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.
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6 Ways to Make Your Risk Management More Effective
Dec 7, 2023 10:00:00 AM | Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.
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6 Ways to Make Your Risk Management More Effective
Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.
ICH Q12 Implementation: Enhancing PACM Agility
Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.
Types of Validation in the Pharmaceutical Industry
All systems, equipment, and processes that have GxP impact require validation. Here are the different types of validation in the pharmaceutical industry.
Six Best Practices for Alcoa Data Integrity
Learn about the significance of ALCOA+ in maintaining data integrity in the pharma industry and best practices for implementing ALCOA+ principles.
What is FDA 21 CFR Part 11 Compliance?
Learn about FDA 21 CFR Part 11 compliance and the regulatory requirements for electronic records and signatures in the life sciences industry.
FDA Warning Letters Expose the Risks of Using Paper Logbooks
Examples from real FDA warning letters show the risks and consequences of using paper logbooks and why a digital logbook management solution is essential.
What Is Paperless Validation All About?
In this post, we'll explore the transition to paperless validation and the benefits it brings such as efficiency, cost reduction, and compliance assurance.
How Can You Simplify Regulatory Approval for PAC?
Learn how to simplify regulatory approval for post-approval changes and discover the benefits of implementing a PACM protocol and using a QRM platform.
What Changes When Your CPV Goes Digital - A ValGenesis Story
Explore the essential role of CPV in your manufacturing process and discover the transformative impact of going digital in this blog post case study.
Generative AI and Its Impact on Validation: Part 2
This post is the second installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.
Generative AI and Its Impact on Validation: Part 1
This post is the first installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.
Removing Bias from Risk Assessment
Discover how to leverage digital CPV to apply the ICH Q9 (R1) data-driven approaches and enable bias-free risk assessment in pharmaceutical manufacturing.
Risk-based CSA Validation: Ensuring the Least Burdensome Approach
The post summarizes the key principles of CSA, various testing methodologies, risk management, and the benefits of digital software validation tools.
How to Make Drug Developability Predictions With Machine Learning
Discover how machine learning unlocks drug developability predictions' potential in a successful case study.
Embracing Change: The Transition from CSV to CSA in Pharmaceuticals
Unlocking the potential of Computer System Assurance (CSA) in pharmaceuticals: A roadmap for a seamless transition from CSV to CSA.
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Featured Content
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
CSV and the Shift to CSA
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.
Previously
Catalent's Journey of Continuous Improvement for CSV Excellence
Are You Aligned with FDA's Computer Software Assurance Methodology?
Cleaning Validation
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.
Cleaning Validation Limits Explained: HBEL/MACO, 10 ppm, and 'Visually Clean'
Explore the complexities of cleaning validation limits, including HBEL/MACO, 10 ppm, and visually clean to ensure patient safety and product quality.
Previously
Change Impact Assessments in ValGenesis iClean™: A Framework for Consistency
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
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