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ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences
ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.
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User Requirements Specification: Creating one for CSA
Apr 20, 2023 9:52:49 AM | This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.
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User Requirements Specification: Creating one for CSA
This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.
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Computer Software Assurance (CSA): What Are Assurance Needs?
Understand the importance of assurance needs in the FDA’s Computer Software Assurance (CSA) approach and how to implement risk-based validation activities.
How Can CSA Simplify Your Validation Processes
A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.
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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.
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.
Transitioning From CSV to CSA
The upcoming transition from CSV to CSA models reduces the cost of validation and provides a more risk and science based approach.
FDA's Computer Software Assurance (CSA) – Part 1 of 3
Traditional computer software validation (CSV) focuses on documentation. Computer software assurance (CSA) focuses on critical thinking.
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.
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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.
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There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.
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Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.
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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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The Benefits of Automating Your Requirements Traceability Matrix
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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.
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
Discover how fully digitalized cleaning validation boosts efficiency, ensures compliance, and transforms operational capacity in pharmaceutical manufacturing.
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The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks
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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.
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
Discover how fully digitalized cleaning validation boosts efficiency, ensures compliance, and transforms operational capacity in pharmaceutical manufacturing.
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Catalent's Journey of Continuous Improvement for CSV Excellence
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