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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Latest News
Should You Use QRM Software for ICH Q9 (R1) Compliance? Yes!
Jul 4, 2024 8:24:43 AM | Quality risk management software ensures compliance with ICH Q9(R1) guidelines, enhancing risk assessments, decision-making, and product safety in pharma.
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Should You Use QRM Software for ICH Q9 (R1) Compliance? Yes!
Quality risk management software ensures compliance with ICH Q9(R1) guidelines, enhancing risk assessments, decision-making, and product safety in pharma.
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.
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.
3 Huge Benefits of Integrating Process Data with Risk Management
In this post, we’ll look at 3 benefits of integrating process data with risk management and how it increases organizational efficiency and competitiveness.
Are You GMP Annex 1 Revision Ready?
Learn about the requirements of the Annex 1 revision and how to ensure compliance with a digital risk management platform.
GMP Annex 1 Revision + QRM Digitalization: a Perfect Match
The EU has released its GMP Annex 1 revision after 14 years of development! This blog post gives a few ideas on how to apply it more easily.
QRM System for ATMPs: Time to Make it Digital
ATMPs are a field that is new, complex, and specific. Having a digital QRM System for ATMPs can have a strong impact in your operations.
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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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