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
Practical Suggestions for ICH Q14 Implementation
Mar 22, 2023 11:59:29 AM | 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.
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>
Digital Transformation: Impacting Global QRM
A blog post about applying digital transformation to the QRM of the top-tiers of the Pharmaceutical Companies and how it can benefit them.
All Tags
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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