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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

Using Digital Twins to Modernize Equipment Qualification

Dec 14, 2023 10:00:00 AM | Is digital twin technology the key to achieving compliant, efficient equipment qualification in the modern life sciences manufacturing industry?

Equipment qualification using digital twins

Using Digital Twins to Modernize Equipment Qualification

Is digital twin technology the key to achieving compliant, efficient equipment qualification in the modern life sciences manufacturing industry?

digital risk management software

6 Ways to Make Your Risk Management More Effective

Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.

drug product assembly line

ICH Q12 Implementation: Enhancing PACM Agility

Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.

Types of Validation in the Pharmaceutical Industry

All systems, equipment, and processes that have GxP impact require validation. Here are the different types of validation in the pharmaceutical industry.

ALCOA+ data integrity

6 Best Practices for ALCOA Data Integrity Success

Learn about the significance of ALCOA+ in maintaining data integrity in the pharma industry and best practices for implementing ALCOA+ principles.

What is FDA 21 CFR Part 11 Compliance?

Learn about FDA 21 CFR Part 11 compliance and the regulatory requirements for electronic records and signatures in the life sciences industry.

exclamation point icon over paper logbook

FDA Warning Letters Expose the Risks of Using Paper Logbooks

Examples from real FDA warning letters show the risks and consequences of using paper logbooks and why a digital logbook management solution is essential. 

What Is Paperless Validation All About?

In this post, we'll explore the transition to paperless validation and the benefits it brings such as efficiency, cost reduction, and compliance assurance.

How Can You Simplify Regulatory Approval for PAC?

Learn how to simplify regulatory approval for post-approval changes and discover the benefits of implementing a PACM protocol and using a QRM platform.

What Changes When Your CPV Goes Digital - A ValGenesis Story

Explore the essential role of CPV in your manufacturing process and discover the transformative impact of going digital in this blog post case study.

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

CRO AmplifyBio Accelerates Trial Success with Digital CSV

Risk-based CSA Validation: Ensuring the Least Burdensome Approach

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

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

Maximize the Use of Technology to Access Real-Time Clean In Place Data

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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