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
Let's Move Beyond Spreadsheets for Risk Management
Mar 14, 2024 10:00:00 AM | Discover why Excel is no longer sufficient for effective risk management in the pharma industry and why transitioning to specialized software is crucial.
Posts about Quality Risk Management:
Let's Move Beyond Spreadsheets for Risk Management
Discover why Excel is no longer sufficient for effective risk management in the pharma industry and why transitioning to specialized software is crucial.
Build an Effective Data Integrity Program with Risk Management
Understand why data integrity problems occur, and learn how to build an effective, risk-based corporate data integrity program to address them.
6 Ways to Make Your Risk Management More Effective
Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.
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.
Removing Bias from Risk Assessment
Discover how to leverage digital CPV to apply the ICH Q9 (R1) data-driven approaches and enable bias-free risk assessment in pharmaceutical manufacturing.
Are You GMP Annex 1 Revision Ready?
Learn about the requirements of the Annex 1 revision and how to ensure compliance with a digital risk management platform.
It's Time to Implement ICH Q9(R1)
In this blog post we'll look into what steps you may need to take to make sure you are compliant with the ICH Q9(R1) guideline.
The 3 Types of Quality Risk Management Tools and What They Do Best
This post highlights the benefits and limitations of 3 types of QRM tools (simple brainstorming tools, simple risk analysis tools, and complex risk classification tools) and provides suggestions for their ideal application.
Cell & Gene Therapies: is Quality by Design Ready for it?
In this blog post, we want to discuss about the application of the Quality by Design for Cell & Gene Therapies. Are they suited for them?
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.
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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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