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Types of Validation in the Pharmaceutical Industry

Nov 23, 2023 8:15:00 AM | All systems, equipment, and processes that have GxP impact require validation. Here are the different types of validation in the pharmaceutical industry.

Posts about Digital Validation:

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.

Generative AI and Its Impact on Validation: Part 2

This post is the second installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.

Generative AI and Its Impact on Validation: Part 1

This post is the first installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.

How Spreadsheets Create Compliance Risks: An Auditor's Perspective

Spreadsheet tools like Excel raise a regulatory red flag and can trigger an audit. Your best defense is a validation lifecycle management system (VLMS).

Requirements Management 101: Tips for Writing Good Requirements

Writing good requirements during the requirements management process is the key to better product quality, accelerated development, and less rework.

12 Reasons to Transition to a Digital Validation Process, Part 2

Paper-based workflows have been the industry standard for validating systems and processes. But companies gain many benefits from going digital. (Part 2 of 2)

What's the Difference Between a VLMS and a DMS?

If you think of validation as a pie, document authoring is 25% of the pie. A DMS can’t address the other 75% of validation activities ValGenesis supports.

Object-Oriented Validation: A Different Way of Thinking

ValGenesis (VLMS) has capitalized on delivering functionality to support object-oriented validation. Here you can create requirements as objects, and these can be shared.

User Requirements Specification: Creating one for CSA

This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.

Twelve Reasons to Transition to a Digital Validation Process, Part 1

Pharma has embraced digitization in many business lines, but validation has been one of the few processes to remain manual. Here are 12 reasons to make the switch! (Part 1 of 2)

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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

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

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