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

Nov 9, 2022 1:22:00 PM | 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: 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".

ValConnect 2022 Session Round-Up: Standardizing Validation Across 19 Sites

Roche/Genentech eliminated 50% of the non-value-added paper-based tasks employees were forced to perform and reallocated resources to prioritize innovation.

ValConnect 2022 Session Round-Up: Building a Digital-First Culture

Digitalization and the Pharma 4.0 vision appeals to young generation engineers from ‘career development’ and ‘cultural engagement’ perspectives.

ValConnect 2022 Session Round-Up: Are Quality & Compliance the Same?

The evolution from compliance to a proactive learning system focused on patient quality outcomes involves overcoming several barriers, says FDA.

Greenfield CDMO Sees Digital Validation as a Competitive Advantage

Faster innovation and time to market are top priorities for CDMOs. Being a digital-first organization gives Theragent a substantial competitive advantage.

Are You Aligned with FDA's Computer Software Assurance Methodology?

CSA is achievable under current regulation. If you’re following these 3 core CSV principles, odds are you’re already aligned with the new CSA methodology.

Accelerate Time-to-market Using a QbD Framework: a ValGenesis Story

We write about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework

ROI Study: Digitizing Validation Yields 50% Overall Efficiency Gain

ROI study reveals how much time and money customers save by digitizing corporate validation processes. Watch the webinar (link in post).

The Challenges of Paper-Based Logbook Management and How to Avoid Them

When manufacturers rely on paper-based logbooks, they expose themselves to human errors, poor data integrity, and a host of compliance risks.

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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

Out-of-the-Box Computer Software Assurance with ValGenesis

Requirement-Level Risk Assessment: A Game-Changer in 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

How Can Digital Cleaning Validation Improve Product Changeover Safety?

Avoiding Common FDA 483 Observations in 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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