CSV vs. CSA: Choosing the Right Path for Software Validation
Learn about choosing between CSV and CSA for software validation. Understand the differences, benefits, and when to apply each method effectively.
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ICH Q12 Implementation: Enhancing PACM Agility
Nov 30, 2023 2:12:33 PM | Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.
Posts about Post-approval Changes:
ICH Q12 Implementation: Enhancing PACM Agility
Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.
How Can You Simplify Regulatory Approval for PAC?
Learn how to simplify regulatory approval for post-approval changes and discover the benefits of implementing a PACM protocol and using a QRM platform.
Comparability for Post-Approval Changes
Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.
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.
Benefit-Risk Assessment for Drug Products
An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by the FDA. Luckily, through a combination of good practices for Benefit-Risk Assessment and technology, this has become much easier.
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.
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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.
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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.
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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.
Five Cleaning Validation Challenges Digitalization Solves
This post examines five cleaning validation challenges that can be eliminated by digitizing your cleaning validation approach with ValGenesis.
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Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes
Maximize the Use of Technology to Access Real-Time Clean In Place Data
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.
The X Factor for Successful Digital Transformation in BioPharma: People
This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising ...
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