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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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QRM Over Lifecycle Management

Mar 22, 2023 11:59:26 AM | Using QRM within a Lifecycle Management framework ensures consistency at all levels where modern pharma operations are concerned.

QRM Over Lifecycle Management

Using QRM within a Lifecycle Management framework ensures consistency at all levels where modern pharma operations are concerned.

Tech Transfer: Planning for Success

Tech Transfer is especially important. When switching facilities, you want to transfer the knowledge and reproduce the process smoothly.

Cell and Gene Therapy: How to Minimize its Risks?

There are still some challenges when it comes to minimizing the risks in Cell and Gene Therapy. Here, we give some thoughts on how to manage and minimize them.

Biosimilars Approval: how to Reduce Time to Market?

In this blog post, we tell what the most effective approach for your biosimilars approval to reduce its time to market is.

Adopting Continuous Manufacturing (CM): The Case of Biologics

Continuous Manufacturing brings quality and delivery many business gains when applied to biologic products.

Cell and Gene Therapy: the Benefits of PAT and QbD

Cell and Gene Therapy products are considered the future of medicine. PAT and QbD can bring many benefits to C>

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.

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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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