The Benefits of Automating Your Requirements Traceability Matrix
Automate your requirements traceability matrix to improve efficiency, reduce compliance risks, and streamline validation for better audit readiness.
Latest News
Benefit-Risk Assessment for Drug Products
Mar 22, 2023 12:00:44 PM | 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.
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.
Knowledge Management (KM): Is the Industry Ready for it?
In this blog post, we’ll go through some concepts on Knowledge Management and the starting points for its implementation.
The Business and Buzz of IoT in Validation
Unlock the potential of IoT in validation and manufacturing to enhance efficiency, reduce costs, and improve product quality across pharmaceutical operations.
Risk Management and Process Optimization: a ValGenesis story
A light story about how ValGenesis joining on a quest to optimize a stage in a process, how did we do it and what came out of it.
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.
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
Catalent's Journey of Continuous Improvement for CSV Excellence
Are You Aligned with FDA's Computer Software Assurance Methodology?
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.
Why Established Pharma Sites Need a Digital Cleaning Validation Strategy
Discover how digital cleaning validation strategies can modernize established pharma facilities, ensuring compliance, efficiency, and patient safety.
Previously
Is Your Cleaning Validation Stuck in the Slow Lane?
Cleaning Validation Program Compliance: Build a Framework for Success
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.
Catalent's Journey of Continuous Improvement for CSV Excellence
Learn how Catalent scaled CSV compliance with ValGenesis VLMS to enhance global IT operations.
Previously
Validating Pharma 4.0 for Smart Manufacturing
The X Factor for Successful Digital Transformation in BioPharma: People
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