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.
Latest News
Cell and Gene Therapies: Risk Management Processes
Mar 22, 2023 11:59:30 AM | In this blog post, we talk about how can you implement Risk Management Processes for Cell and Gene Therapies to every aspect of your product.
Cell and Gene Therapies: Risk Management Processes
In this blog post, we talk about how can you implement Risk Management Processes for Cell and Gene Therapies to every aspect of your product.
Practical Suggestions for ICH Q14 Implementation
The new ICH Q14 guideline is here! How to implement it? We talked with Jean-François Dierick and Claudia Magagnoli on how they did it at GSK.
The new ICH Q13 Guideline is Almost Here!
The new ICH Q13 guideline is almost here! ValGenesis' experts have been actively involved on the public consultation phase and, we have something to say about it.
Business Continuity in Pharma: the Role of Risk Management
Assuring business continuity in pharma can be complex. Effective risk management strategies can help you operate during disruptions.
QRM Over Lifecycle Management
Using QRM within a Lifecycle Management framework ensures consistency at all levels where modern pharma operations are concerned.
Tech Transfer: Planning for Success
Tech Transfer is especially important. When switching facilities, you want to transfer the knowledge and reproduce the process smoothly.
Cell and Gene Therapy: How to Minimize its Risks?
There are still some challenges when it comes to minimizing the risks in Cell and Gene Therapy. Here, we give some thoughts on how to manage and minimize them.
Biosimilars Approval: how to Reduce Time to Market?
In this blog post, we tell what the most effective approach for your biosimilars approval to reduce its time to market is.
Adopting Continuous Manufacturing (CM): The Case of Biologics
Continuous Manufacturing brings quality and delivery many business gains when applied to biologic products.
Cell and Gene Therapy: the Benefits of PAT and QbD
Cell and Gene Therapy products are considered the future of medicine. PAT and QbD can bring many benefits to C>
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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.
Why Established Pharma Sites Need a Digital Cleaning Validation Strategy
Discover how digital cleaning validation strategies can modernize established pharma facilities, ensuring compliance, efficiency, and patient safety.
Previously
Is Your Cleaning Validation Stuck in the Slow Lane?
Cleaning Validation Program Compliance: Build a Framework for Success
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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