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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

Does Quality Culture Affect pQMS Outcomes? Absolutely.

Apr 20, 2023 9:52:54 AM | This post examines the crucial impact quality culture has on individuals, organizations, and processes; it offers tips for improving it in your company.

All Blog Posts

Does Quality Culture Affect pQMS Outcomes? Absolutely.

This post examines the crucial impact quality culture has on individuals, organizations, and processes; it offers tips for improving it in your company.

User Requirements Specification: Creating one for CSA

This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.

Finding a Root-cause in a Filter Clogging at Drug Product Filtration

This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.  

Removing Subjectivity in Risk Assessments

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

Risk Management for Medical Devices

Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.

Transitioning From CSV to CSA

The upcoming transition from CSV to CSA models reduces the cost of validation and provides a more risk and science based approach.

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.

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.

Risk Management and Process Optimization: a ValGenesis story

A light story about how ValGenesis joining on a quest to optimize a stage in a process, how did we do it and what came out of it.

GMP Annex 1 Revision + QRM Digitalization: a Perfect Match

The EU has released its GMP Annex 1 revision after 14 years of development! This blog post gives a few ideas on how to apply it more easily.

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.

Digital Transformation: Impacting Global QRM

A blog post about applying digital transformation to the QRM of the top-tiers of the Pharmaceutical Companies and how it can benefit them.

Optimizing a Perfusion Cell Culture: a ValGenesis Story

This is a post about optimising a perfusion cell culture, using a combination of Root Cause Anlysis and Corrective and Preventive Action.

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

QRM System for ATMPs: Time to Make it Digital

ATMPs are a field that is new, complex, and specific. Having a digital QRM System for ATMPs can have a strong impact in your operations.

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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