Out-of-the-Box Computer Software Assurance with ValGenesis
Simplify your transition to computer software assurance (CSA) with ValGenesis VLMS. Discover key features that streamline your validation processes.
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.
Posts about Quality Risk Management (3):
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.
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.
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.
Medical Cannabis: the QRM Practices that Improve Your Business
A blog post where we give you some tips on how Quality Risk Management can help you improve your Medical Cannabis business
QRM System for ATMPs: Time to Make it Digital
ATMPs are a field that is new, complex, and specific. Having a digital QRM System for ATMPs can have a strong impact in your operations.
Risk Management of Sterilising Filtration
In this blog post we will talk about the perform Risk Management of Sterilising Filtration. We present the steps, the methods and the tools!
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
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.
How Can Digital Cleaning Validation Improve Product Changeover Safety?
Learn how digital cleaning validation solutions can prevent cross-contamination and ensure drug safety during product changeovers in pharma manufacturing.
Previously
Avoiding Common FDA 483 Observations in Cleaning Validation
What are the Regulatory Expectations for Cleaning Validation?
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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