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

Move Beyond Manual CQV Challenges with Digital Solutions

Oct 31, 2024 1:54:17 PM | Discover how digital CQV with ValGenesis VLMS streamlines compliance, cuts costs, and boosts efficiency, supported by customer metrics that demonstrate measurable ROI.

All Blog Posts

Move Beyond Manual CQV Challenges with Digital Solutions

Discover how digital CQV with ValGenesis VLMS streamlines compliance, cuts costs, and boosts efficiency, supported by customer metrics that demonstrate measurable ROI.

Two circles touching to illustrate the alignment of the CSA and GAMP 5 frameworks

How Do the FDA's CSA Guidance and ISPE's GAMP 5 Align?

Learn how ISPE's GAMP 5 Guideline and the FDA's CSA Guidance play complementary roles in ensuring the integrity and reliability of computerized systems.

Best Practices in Commissioning and Qualification ― Part Two

Discover best practices for integrating your commissioning and qualification processes and how to streamline C&Q activities with robust digital solutions.

Best Practices in Commissioning and Qualification ― Part One

Learn best practices for implementing an integrated commissioning and qualification approach and the 5 critical elements to include in your C&Q plan.

Best Practices for Process Validation in the Pharmaceutical Industry

Learn best practices for process validation in the pharma industry. Find out how digitalization streamlines validation operations and improves product quality.

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.

FDA Warning Letters Expose the Risks of Using Paper Logbooks

Examples from real FDA warning letters show the risks and consequences of using paper logbooks and why a digital logbook management solution is essential. 

Illustration showing paperless validation transition from paper documents to digital workflows with connected data and compliance tracking

What Is Paperless Validation All About?

In this post, we'll explore the transition to paperless validation and the benefits it brings such as efficiency, cost reduction, and compliance assurance.

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 to Overcome the Subjectivity of Objective Evidence in FDA Audits

How do we deliver objective evidence with a high degree of certainty it will withstand regulatory scrutiny? Technology tools like a VLMS hold the answer.

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).

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.

Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

Quality Risk Management

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

Tech Transfer & Process Scale-up

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-Based Cleaning Validation: A Lifecycle Approach

Cleaning Validation

Risk-Based Cleaning Validation: A Lifecycle Approach

Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.

Kenneth Pierce

Written by
Kenneth Pierce

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

Catalent's Journey of Continuous Improvement for CSV Excellence

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

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

Change Impact Assessments in ValGenesis iClean™: A Framework for Consistency

Unlocking Operational Capacity with Fully Digitalized 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.

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.