Leveraging Vendor Testing: A Smarter Approach to Validation
Learn how to reduce costs, improve accuracy, and enhance compliance by integrating vendor-provided testing into your validation framework.
Latest News
Generative AI and Its Impact on Validation: Part 1
Sep 7, 2023 11:01:31 AM | 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.
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.
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.
Saving Time and Resources with CSA
In this blog post, we will explore how making your transition from the traditional CSV to the new CSA approach can save you time and resources.
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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
Out-of-the-Box Computer Software Assurance with ValGenesis
Requirement-Level Risk Assessment: A Game-Changer in Validation
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.
Equipment Design in Cleaning Validation: Enhancing Your Sampling Plan
Discover the importance of equipment design in cleaning validation and how ValGenesis Process Manager improves sampling plans and ensures compliance.
Previously
How Can Digital Cleaning Validation Improve Product Changeover Safety?
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.
Validating Pharma 4.0 for Smart Manufacturing
Explore how Pharma 4.0 leverages advanced technologies to revolutionize pharmaceutical manufacturing, enhancing efficiency, quality, and patient-centric outcomes.
Previously
The X Factor for Successful Digital Transformation in BioPharma: People
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