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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

QRM System for ATMPs: Time to Make it Digital

Mar 22, 2023 11:59:17 AM | 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.

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.

CPV Implementation: how to do it?

This blog post will give you a few tips on how to do a CPV implementation and the different requirements you need to make it successful.

Risk Management of Sterilising Filtration

In this blog post we will talk about the perform Risk Management of Sterilising Filtration. We present the steps, the methods and the tools!

How to Support Global Manufacturing of Pharma Products

Process, product performance and comparability are key to global production. This is how to support global manufacturing of pharma products. 

Tablet Computing in GMP Environments: Flashy Gadget or Useful Tool?

This post examines four reasons tablet computers are ideal for validating computer systems, equipment, and instruments in controlled GMP manufacturing environments.

Paperless Validation Trends in Pharma, Biotech, and Medical Devices

Paperless validation technology has been available for over a decade, but the life sciences industry has been slow to adopt it. But things are changing.

Business Continuity and Disaster Recovery in FDA-Regulated Industries

Digitization is the process of converting text, pictures (including video), and sound into a digital form that can be processed by computer technology.

ValConnect 2022 Session Round‑Up: Philips Harmonizes CSV Processes

Philips needed a digital validation system that could standardize its paper-based computer system validation (CSV) efforts across multiple geographies.

ValConnect 2022 Session Round-Up: The Power of "New Science"

New Science can deliver accessible, affordable, and transformative patient outcomes when built on well-defined outgrowth strategies that access emerging technologies.

ValConnect 2022 Session Round-up: CPV for New and Legacy Products

“CPV is a broader concept because it gives you a more holistic picture of overall product performance over a period of time. While both APR and CPV give you an indication of product performance, the current situation in most companies is that they remain disconnected".

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

6 Ts to Drive Computer Software Assurance Adoption

CRO AmplifyBio Accelerates Trial Success with Digital CSV

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

Five Cleaning Validation Challenges Digitalization Solves

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

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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