Leveraging Vendor Testing: A Smarter Approach to Validation
Learn how to reduce costs, improve accuracy, and enhance compliance by integrating vendor-provided testing into your validation framework.
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Critical Thinking and Its Role in Computer Software Assurance (CSA)
Mar 22, 2023 12:00:58 PM | Critical thinking is a vital life skill and the principal requirement of CSA. Are you a critical thinker? Read on to find out.
Posts about Computer Software Assurance (CSA) (3):
Critical Thinking and Its Role in Computer Software Assurance (CSA)
Critical thinking is a vital life skill and the principal requirement of CSA. Are you a critical thinker? Read on to find out.
Computer Software Assurance (CSA): Focus on Records, Not Documentation
The thinking is the more paper you generate, the better you validate. According to the FDA, this is not only wrong, it's dangerous.
FDAs Computer Software Assurance (CSA) – Part 2 of 3
Changing mindsets from compliance-centric to quality-focused isn’t easy. It’s possibly the most difficult change to make, but it’s necessary for a quality culture to take hold.
Are You Aligned with FDA's Computer Software Assurance Methodology?
CSA is achievable under current regulation. If you’re following these 3 core CSV principles, odds are you’re already aligned with the new CSA methodology.
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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.
Previously
Out-of-the-Box Computer Software Assurance with ValGenesis
Requirement-Level Risk Assessment: A Game-Changer in Validation
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.
Equipment Design in Cleaning Validation: Enhancing Your Sampling Plan
Discover the importance of equipment design in cleaning validation and how ValGenesis Process Manager improves sampling plans and ensures compliance.
Previously
How Can Digital Cleaning Validation Improve Product Changeover Safety?
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.
Validating Pharma 4.0 for Smart Manufacturing
Explore how Pharma 4.0 leverages advanced technologies to revolutionize pharmaceutical manufacturing, enhancing efficiency, quality, and patient-centric outcomes.
Previously
The X Factor for Successful Digital Transformation in BioPharma: People
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