Blog

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

The Pharma 4.0 Vision for Manufacturing Intelligence

Mar 22, 2023 12:00:51 PM | Digital validation and automation meet complex product lifecycle needs but they're only enablers to the intelligence at the heart of manufacturing activity. Learn how ValGenesis is expanding its product vision beyond validation toward a holistic manufacturing intelligence platform.

The Pharma 4.0 Vision for Manufacturing Intelligence

Digital validation and automation meet complex product lifecycle needs but they're only enablers to the intelligence at the heart of manufacturing activity. Learn how ValGenesis is expanding its product vision beyond validation toward a holistic manufacturing intelligence platform.

ValConnect 2022 – Day Three Round-Up

ValConnect 2022 is a wrap! Read the recap, and watch today's keynote from Dr. Ajaz Hussain. See you next year!

FDAs Computer Software Assurance (CSA) – Part 2 of 3

Changing mindsets from compliance-centric to quality-focused isn’t easy. It’s possibly the most difficult change to make, but it’s necessary for a quality culture to take hold.

Data Integrity by Design is Your First Line of Defense!

Each of the above is important. However, the critical point is that data integrity should be designed into the system right from the beginning. Data integrity should be at the forefront of system development (i.e, design).

The Benefits of a Cloud-Based Digital Validation System

Cloud-based digital validation allows you to recover in the event of a disaster, ensuring business continuity and compliance.

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.

Knowledge Management (KM): Is the Industry Ready for it?

In this blog post, we’ll go through some concepts on Knowledge Management and the starting points for its implementation.

The Business and Buzz of IoT in Validation

The Internet of Things (IoT), sometimes described as an interconnected enterprise system, creates quite the buzz in business circles today. Connecting data, information, and knowledge certainly carries the potential power of creating intelligence to leap ahead of the competition.

4 Conversations to Drive Your Business Case for Digital Validation

Use these 4 conversation starters to overcome the common hurdles to digital validation and make a compelling case for transitioning to a paperless system.

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.

All Tags

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

High-quality Content Straight to Your Inbox!

Join our newsletter to receive updates on the latest news and industry-related content tailored to your preferences. 

newsletter