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.
Latest News
What Changes When Your CPV Goes Digital - A ValGenesis Story
Sep 21, 2023 1:27:56 PM | Explore the essential role of CPV in your manufacturing process and discover the transformative impact of going digital in this blog post case study.
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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.
Can Blockchain Technology Boost Data Integrity in Clinical Trials?
Blockchain technology is revolutionizing how data integrity is ensured in clinical trials, establishing a new level of trust and compliance.
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.
How to Overcome the Subjectivity of Objective Evidence in FDA Audits
How do we deliver objective evidence with a high degree of certainty it will withstand regulatory scrutiny? Technology tools like a VLMS hold the answer.
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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
Quality Risk Management
Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis
Read the industry insight on the topic of Quality Risk Management
Presented by
Sandra Silva
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
Embracing Change: The Transition from CSV to CSA in Pharmaceuticals
How to Overcome the Subjectivity of Objective Evidence in FDA Audits
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.
Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes
ValGenesis Process Manager can help life sciences companies avoid FDA 483s and establish a harmonized cleaning validation program companywide.
Previously
Maximize the Use of Technology to Access Real-Time Clean In Place Data
Cleaning Validation Stage 1: On a Quest for Process Understanding
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.
The X Factor for Successful Digital Transformation in BioPharma: People
This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising ...
Previously
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