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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.

Latest News

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.

All Blog Posts

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.

Illustration of interconnected gears, with icons representing uniting risk assessment with continued process verification cpv

How Integrating Risk Assessment and CPV Increases Patient Safety

Integrating risk assessment and continued process verification with digital technology enhances patient safety and optimizes processes in the pharma industry.

Removing Bias from Risk Assessment

Discover how to leverage digital CPV to apply the ICH Q9 (R1) data-driven approaches and enable bias-free risk assessment in pharmaceutical manufacturing.

It's Time to Implement ICH Q9(R1)

In this blog post we'll look into what steps you may need to take to make sure you are compliant with the ICH Q9(R1) guideline.

Removing Subjectivity in Risk Assessments

In this blog post we explore the topic of minimising the subjectivity in Risk Assessments through Digitalisation of processes.

Benefit-Risk Assessment for Drug Products

An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by the FDA. Luckily, through a combination of good practices for Benefit-Risk Assessment and technology, this has become much easier.

Business Continuity in Pharma: the Role of Risk Management

Assuring business continuity in pharma can be complex. Effective risk management strategies can help you operate during disruptions.

Medical Cannabis: the QRM Practices that Improve Your Business

A blog post where we give you some tips on how Quality Risk Management can help you improve your Medical Cannabis business

Risk Management of Sterilising Filtration

In this blog post we will talk about the perform Risk Management of Sterilising Filtration. We present the steps, the methods and the tools!

Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

Quality Risk Management

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

Tech Transfer & Process Scale-up

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-Based Cleaning Validation: A Lifecycle Approach

Cleaning Validation

Risk-Based Cleaning Validation: A Lifecycle Approach

Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.

Kenneth Pierce

Written by
Kenneth Pierce

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

Catalent's Journey of Continuous Improvement for CSV Excellence

4 Conversations to Drive Your Business Case for Digital 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.

Previously

Unlocking Operational Capacity with Fully Digitalized Cleaning Validation

The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks

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.

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