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
Finding the Root-Cause in a Process: a ValGenesis Story
Apr 20, 2023 10:37:17 AM | A light story about how ValGenesis joining on a quest to finding the root cause of a deviation in a process, how did we do it and what came of it.
Posts about Quality Risk Management (2):
Finding the Root-Cause in a Process: a ValGenesis Story
A light story about how ValGenesis joining on a quest to finding the root cause of a deviation in a process, how did we do it and what came of it.
How to Align Analytical QbD With the new ICH Q14?
How to connect already existing AQbD with the new ICH Q14? Jean-François Dierick and Claudia Magagnoli from GSK explained us how!
How to Design a Control Strategy for Analytical Procedures
An efficient control strategy will ensure your processes performs always as expected. In this blog post we described the steps to design one.
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.
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.
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.
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.
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.
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.
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.
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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