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.
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Out-of-the-Box Computer Software Assurance with ValGenesis
Oct 8, 2024 9:26:09 AM | Simplify your transition to computer software assurance (CSA) with ValGenesis VLMS. Discover key features that streamline your validation processes.
Posts about Computer Software Assurance (CSA):
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.
Embracing Change: The Transition from CSV to CSA in Pharmaceuticals
Unlocking the potential of Computer System Assurance (CSA) in pharmaceuticals: A roadmap for a seamless transition from CSV to CSA.
Saving Time and Resources with CSA
In this blog post, we will explore how making your transition from the traditional CSV to the new CSA approach can save you time and resources.
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
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.
Avoiding Common FDA 483 Observations in Cleaning Validation
Learn to avoid FDA 483 observations in cleaning validation to ensure patient safety and product efficacy. Protect your business with these actionable strategies.
Previously
What are the Regulatory Expectations for Cleaning Validation?
Best Practices for Impact Assessments in Cleaning Validation
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 ...
Previously
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