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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

Digitalizing Pharma Control Strategies: A Roadmap

Sep 12, 2024 10:14:00 AM | Transform pharma manufacturing with digital control strategies. Learn how to enhance product quality, streamline processes, and ensure regulatory compliance.

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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.

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.

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 iCMC

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.

Illustration of a female commissioning and qualification (C&Q) engineer with lab equipment, holding a tablet.

Driving Success with Digital C&Q and Pharma 4.0

Learn about the benefits and impact of transitioning to digital C&Q solutions for enhanced efficiency, compliance, and innovation in a Pharma 4.0 world.

Avoiding the Pitfalls of PQRs with Digital Solutions

Learn to enhance Product Quality Reviews (PQRs) with digital solutions that drive quality improvement and regulatory compliance in pharma manufacturing.

Illustration of a scientist in a lab coat holding a tablet. Background images include scientific icons like a DNA strand, molecular structures, a microscope, test tubes, and beakers. The color scheme is predominantly blue and white, giving a modern, technological feel. ValGenesis logo is visible in the top left corner.

NEXA | EAM Streamlines Equipment Qualification with ValGenesis VLMS

This case study highlights the transformative impact of VLMS technology to modernize equipment qualification processes and drive operational excellence at NEXA.

Tablet displaying risk levels (Low, Medium, High, Critical) with a magnifying glass and check mark, against a dashboard background.

Should You Use QRM Software for ICH Q9 (R1) Compliance? Yes!

Quality risk management software ensures compliance with ICH Q9(R1) guidelines, enhancing risk assessments, decision-making, and product safety in pharma.

ValConnect 2024 event badge and lanyard

ValConnect 2024: A Global Gathering in Lisbon

Discover the highlights from ValConnect 2024, showcasing cutting-edge technologies, customer success stories, and the unveiling of ValGenesis VLMS 5.0.

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.

Harnessing the Power of Machine Learning for R&D in Drug Discovery

Machine learning (ML) is transforming early-phase drug screening, enhancing efficiency and predictive accuracy. Learn how to apply it to your R&D process.

Blue rocket labeled ValGenesis VLMS 5.0 surrounding by icons for AI innovation, regulatory alignment, CSA-ready, enhanced analytics, critical thinking, and risk-based approach. Blue background with V logo.

ValGenesis VLMS 5.0: Next-Gen Validation Lifecycle Management

ValGenesis 5.0 delivers a next-generation user experience through redesigned workflows, speed enhancements, a modern UI, and AI-powered productivity.

Diagram depicting the steps in implementing a QBD approach

How to Apply a Quality by Design Framework with ValGenesis iCMC

Learn how ValGenesis iCMC integrates Quality by Design principles with CMC lifecycle management to enhance pharmaceutical process development.

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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-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

The Benefits of Automating Your Requirements Traceability Matrix

Catalent's Journey of Continuous Improvement for CSV Excellence

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

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

Digital Cleaning Validation: From Lifecycle Control to Real-Time Assurance

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

Catalent's Journey of Continuous Improvement for CSV Excellence

Validating Pharma 4.0 for Smart Manufacturing

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