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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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Requirement-Level Risk Assessment: A Game-Changer in Validation

Oct 3, 2024 10:00:00 AM | Discover how ValGenesis VLMS optimizes validation with requirement-level risk assessment to enhance efficiency, compliance, and product quality.

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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.

Three stopwatches showing a countdown, with the last one sounding an alarm.

Mastering Equipment Hold Time Controls with Electronic Logbooks

Optimize pharma manufacturing with ValGenesis e-Logbook for automated clean/dirty hold time management. Ensure compliance, efficiency, and patient safety.

The image shows two professionals in lab coats—one holding a clipboard, the other using a tablet—surrounded by icons like warnings, charts, and a question mark, suggesting the advantages of digital CPV over manual CPV.

Save Time and Resources with Digital Continued Process Verification

Discover how digital CPV optimizes pharmaceutical manufacturing, reducing time, costs, and errors through real-time monitoring and automated processes.

Digitalizing Pharma Control Strategies: A Roadmap

Transform pharma manufacturing with digital control strategies. Learn how to enhance product quality, streamline processes, and ensure regulatory compliance.

An illustration of a hand wiping down laboratory equipment. The FDA 483 warning label is displayed in the foreground.

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.

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.

Drug capsules on conveyor belt in manufacturing facility

A Toolbox for Effective Tech Transfer

Discover how digital tools simplify tech transfer in Pharma 4.0, enhancing efficiency, product quality, and speed to market in the pharmaceutical industry.

An isometric illustration of a clean laboratory workspace. A hand wipes down a white countertop next to lab equipment, including a hot plate, flasks, and a magnetic stirrer.

What are the Regulatory Expectations for Cleaning Validation?

Explore the regulatory expectations for cleaning validation, the challenges faced, and how ValGenesis Process Manager can help you simplify compliance.

A person drawing a manufacturing process on a whiteboard in a pharmaceutical lab. The scene includes a table with test tubes, and lab equipment.

Better Pharmaceutical Development: A Case for ValGenesis iRisk

See how ValGenesis iRisk transforms pharmaceutical development by integrating QbD and AQbD, streamlining processes, improving quality, and expediting approvals.

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.

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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

Rethinking Validation: Why CSV Falls Short for Agile Teams

Top 5 Misconceptions About Computer Software Assurance

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

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.

Previously

The Pharma 4.0 Vision for Manufacturing Intelligence

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