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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.
Latest News
Digital Quality Risk Management: A ValGenesis Story
Jan 22, 2024 10:30:00 AM | Learn about ValGenesis iRisk, an advanced tool for digital quality risk management, and its impact on vaccine development at a top biopharma company.
All Blog Posts
Digital Quality Risk Management: A ValGenesis Story
Learn about ValGenesis iRisk, an advanced tool for digital quality risk management, and its impact on vaccine development at a top biopharma company.
Best Practices for Process Validation in the Pharmaceutical Industry
Learn best practices for process validation in the pharma industry. Find out how digitalization streamlines validation operations and improves product quality.
Five Cleaning Validation Challenges Digitalization Solves
This post examines five cleaning validation challenges that can be eliminated by digitizing your cleaning validation approach with ValGenesis.
Build an Effective Data Integrity Program with Risk Management
Understand why data integrity problems occur, and learn how to build an effective, risk-based corporate data integrity program to address them.
Using Digital Twins to Modernize Equipment Qualification
Is digital twin technology the key to achieving compliant, efficient equipment qualification in the modern life sciences manufacturing industry?
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.
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Featured Content
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
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
The Benefits of Automating Your Requirements Traceability Matrix
Catalent's Journey of Continuous Improvement for CSV Excellence
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.
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
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
Pharma 4.0
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.
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
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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