The Benefits of Automating Your Requirements Traceability Matrix
Automate your requirements traceability matrix to improve efficiency, reduce compliance risks, and streamline validation for better audit readiness.
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How Can CSA Simplify Your Validation Processes
Apr 12, 2023 11:11:26 AM | A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.
How Can CSA Simplify Your Validation Processes
A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.
Developing a Retrospective QbD: a ValGenesis Story
A story about this time we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology.
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How Computer Software Assurance Will Impact Traditional CSV Testing
Computer software assurance (CSA) encourages the use of unscripted test methods, such as ad hoc testing, and automated technologies.
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Removing Subjectivity in Risk Assessments
In this blog post we explore the topic of minimising the subjectivity in Risk Assessments through Digitalisation of processes.
Computer Software Assurance (CSA): What's All the Hype?
Computer software validation (CSV) and computer software assurance (CSA) aren't all that different. So then, what's all the hype about? Let's discuss.
Challenges on Comparability Studies on Early Development Stages
This blog post goes over the key aspects of developing solid comparability studies on early development stages.
Risk Management for Medical Devices
Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.
Q&A About Compliant, AR-Driven Hands-Free Validation
AR-driven hands-free validation isn’t just a futuristic concept; it’s available now. In this insightful Q&A, Steve Thompson discusses how it will transform GMP production environments.
New ICH Q14 Guideline: key Implementation Aspects
The ICH released a draft version of the new ICH Q14 Guideline last March. This blog post will give you an overview of its key implementation aspects.
ValConnect 2022 – Day One Round-Up
ValConnect 2022 is off to a great start! Today's agenda featured live product demos and a keynote from Roche/Genentech. Here's a recap of day one.
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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
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.
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Why Modernizing Cleaning Validation Is Crucial for Compliance
Learn why cleaning validation in pharma is under regulatory scrutiny and how replacing manual processes with digital tools strengthens compliance.
Previously
Why Established Pharma Sites Need a Digital Cleaning Validation Strategy
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.
Catalent's Journey of Continuous Improvement for CSV Excellence
Learn how Catalent scaled CSV compliance with ValGenesis VLMS to enhance global IT operations.
Previously
Validating Pharma 4.0 for Smart Manufacturing
The X Factor for Successful Digital Transformation in BioPharma: People
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