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
Developing a Drug Product Using QbD: a ValGenesis Story
Mar 22, 2023 11:59:36 AM | This story is about our project with Libbs Farmacêutica to successfully apply a QbD framework in the development of an oral drug product
Developing a Drug Product Using QbD: a ValGenesis Story
This story is about our project with Libbs Farmacêutica to successfully apply a QbD framework in the development of an oral drug product
Creating a Post-approval Change Management (PACM) Protocol
In this blog post, we will give you all the steps about how to create a PACM protocol and how ICH Q12 supports you in it.
How to Set up a Digital CPV Plan in 3 Steps
In this blog post, we'll give you some tips that help you setting up a Digital CPV plan in only three steps.
How to Improve Business Efficiency With Digital Validation
In this blog post, we show you how digital validation can improve your validation process and enhance your business efficiency.
GMP Annex 1 Revision + QRM Digitalization: a Perfect Match
The EU has released its GMP Annex 1 revision after 14 years of development! This blog post gives a few ideas on how to apply it more easily.
Process Analytical Technology in Continuous Manufacturing
If you are looking to reap the full benefits of Continuous Manufacturing, this a post is about how to use PAT for advanced analytics applications.
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.
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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