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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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4 Life Sciences Lessons from the PAT to QbD Journey

Apr 12, 2023 11:11:06 AM | In our journey to instill quality culture across life sciences, we've learned several valuable lessons along the way. The bottom line: continued training and development matters more than ever.

4 Life Sciences Lessons from the PAT to QbD Journey

In our journey to instill quality culture across life sciences, we've learned several valuable lessons along the way. The bottom line: continued training and development matters more than ever.

Cleaning Validation Stage 2: Performance Qualification

The second stage of the validation lifecycle is called Process Qualification. This stage is customary and is referred to as Cleaning Validation. Usually, three consecutive successful runs are performed to qualify the process using well characterized, well documented and consistent cleaning procedures.

FDA's Computer Software Assurance (CSA) – Part 1 of 3

Traditional computer software validation (CSV) focuses on documentation. Computer software assurance (CSA) focuses on critical thinking.

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.

Boost Efficiency with Digital Equipment Qualification and Validation

Traditional equipment validation is a manual, inefficient paper-based process plagued with bottlenecks and high cost. It's time to go digital.

Critical Thinking and Its Role in Computer Software Assurance (CSA)

Critical thinking is a vital life skill and the principal requirement of CSA. Are you a critical thinker? Read on to find out.

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.

Computer Software Assurance (CSA): Focus on Records, Not Documentation

The thinking is the more paper you generate, the better you validate. According to the FDA, this is not only wrong, it's dangerous.

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!

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

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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