How Do the FDA's CSA Guidance and GAMP 5 Align?
Learn how ISPE's GAMP 5 Guideline and the FDA's CSA Guidance play complementary roles in ensuring the integrity and reliability of computerized systems.
Latest News
Developing a Retrospective QbD: a ValGenesis Story
Apr 12, 2023 11:11:25 AM | A story about this time we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology.
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.
How Computer Software Assurance Will Impact Traditional CSV Testing
Computer software assurance (CSA) encourages the use of unscripted test methods, such as ad hoc testing, and automated technologies.
Removing Subjectivity in Risk Assessments
In this blog post we explore the topic of minimising the subjectivity in Risk Assessments through Digitalisation of processes.
Computer Software Assurance (CSA): What's All the Hype?
Computer software validation (CSV) and computer software assurance (CSA) aren't all that different. So then, what's all the hype about? Let's discuss.
Challenges on Comparability Studies on Early Development Stages
This blog post goes over the key aspects of developing solid comparability studies on early development stages.
Risk Management for Medical Devices
Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.
Q&A About Compliant, AR-Driven Hands-Free Validation
AR-driven hands-free validation isn’t just a futuristic concept; it’s available now. In this insightful Q&A, Steve Thompson discusses how it will transform GMP production environments.
New ICH Q14 Guideline: key Implementation Aspects
The ICH released a draft version of the new ICH Q14 Guideline last March. This blog post will give you an overview of its key implementation aspects.
ValConnect 2022 – Day One Round-Up
ValConnect 2022 is off to a great start! Today's agenda featured live product demos and a keynote from Roche/Genentech. Here's a recap of day one.
Commissioning and Qualification in the Life Sciences
Traditional commissioning and qualification can be very challenging due to the inefficiencies, compliance risk, lack of data integration, inability to adequately track and close out activities.
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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.
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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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