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.
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Are You Aligned with FDA's Computer Software Assurance Methodology?
Jan 17, 2025 8:30:00 AM | If you’re following these 3 core principles, odds are you’re already aligned with the FDA's computer software assurance (CSA) methodology.
Posts about Computer Software Assurance (CSA):
Are You Aligned with FDA's Computer Software Assurance Methodology?
If you’re following these 3 core principles, odds are you’re already aligned with the FDA's computer software assurance (CSA) methodology.
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.
Out-of-the-Box Computer Software Assurance with ValGenesis
Simplify your transition to computer software assurance (CSA) with ValGenesis VLMS. Discover key features that streamline your validation processes.
Requirement-Level Risk Assessment: A Game-Changer in Validation
Discover how ValGenesis VLMS optimizes validation with requirement-level risk assessment to enhance efficiency, compliance, and product quality.
Rethinking Validation: Why CSV Falls Short for Agile Teams
Learn how traditional CSV conflicts with Agile development principles and why computer software assurance (CSA) is a better fit for Agile environments.
Top 5 Misconceptions About Computer Software Assurance
As life sciences companies work to ensure the quality and safety of their software systems, it's essential to understand the true intentions and uses of CSA.
What's Stopping You? Overcoming CSA Adoption Concerns
Explore the benefits of computer software assurance for software validation in life sciences. Learn how digital tools address common fears of CSA adoption.
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.
6 Ts to Drive Computer Software Assurance Adoption
Explore what's needed to successfully adopt the FDA's computer software assurance (CSA) guidance in your life sciences company.
Risk-based CSA Validation: Ensuring the Least Burdensome Approach
The post summarizes the key principles of CSA, various testing methodologies, risk management, and the benefits of digital software validation tools.
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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
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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