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Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.

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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):

 A person clears a hurdle, symbolizing quick and easy software setup for computer software assurance.

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.

A woman pointing at a digital interface with a checklist of software requirements and colored indicators of risk levels.

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.

The image contrasts two figures: on the left, a person sweating while holding a large stack of paperwork and an hourglass, symbolizing a slow process. On the right, a person sits at a laptop, surrounded by icons like a light bulb, rocket, and gear with a checkmark, representing efficiency and agility.

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.

Illustration representing computer software assurance (CSA) with icons showing testing, risk, and guidance comparison, including 2002 Guidance and CSA Guidance

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.

Man in front of computer, question marks above his head. Concept of uncertainty around implementing computer software assurance, a new approach to software validation in life sciences.

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.

Intersecting circle diagram linking CSA guidance to GAMP 5

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.

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Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

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.

Sofia Santos

Written by
Sofia Santos

How to Accelerate Process Scale-Up With Effective Tech Transfer

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.

Sofia Santos

Written by
Sofia Santos

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Quality Risk Management

Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis

Read the industry insight on the topic of Quality Risk Management

Sandra Silva

Presented by
Sandra Silva

Trending Topics With ValGenesis Customers

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

Rethinking Validation: Why CSV Falls Short for Agile Teams

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.

Previously

Avoiding Common FDA 483 Observations in Cleaning Validation

What are the Regulatory Expectations for 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.

Previously

The X Factor for Successful Digital Transformation in BioPharma: People

The Pharma 4.0 Vision for Manufacturing Intelligence

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