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

Risk-Based Cleaning Validation: A Lifecycle Approach to Compliance and Efficiency

Oct 17, 2025 4:43:31 PM | Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.

All Blog Posts

Infographic showing the risk-based cleaning validation lifecycle, with three connected phases: design (process mapping), performance qualification (gear with checkmark), and monitoring (data analytics)

Risk-Based Cleaning Validation: A Lifecycle Approach to Compliance and Efficiency

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

Illustration of a tablet displaying “FDA 483” with a checklist under a magnifying glass, representing cleaning validation. “Part 1” appears in the top right corner.

Why Cleaning Validation Still Tops FDA 483 Observations

Explore why cleaning validation remains a top FDA 483 observation, its regulatory history, and ongoing importance. Part 1 of our Future of CV series.

Illustration comparing paper-based CQV with digital equipment validation: paper files cause delays and risks, while digital workflows enable faster, compliant, and secure validation

Reevaluating Paper-Based CQV: Why Clinging to Tradition Increases Risk

Learn how digital equipment qualification in the pharmaceutical industry reduces risk and accelerates product release by replacing paper-based CQV processes.

Map highlighting ValConnect Innovation Day 2025 locations: Princeton, Frankfurt, and Hyderabad.

ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences

ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.

An isometric illustration of a clean laboratory workspace. A hand wipes down a white countertop next to lab equipment, including a hot plate, flasks, and a magnetic stirrer.

What Are the Regulatory Expectations for Cleaning Validation?

Learn why cleaning validation is important, what FDA and global guidelines require, and how a digital system can reduce risk and ensure GMP compliance.

Illustration of a stressed worker holding an error-filled spreadsheet, highlighting manual vs digital QbD in pharma.

Why Manual QbD Leads to Delays, Errors, and Ongoing Frustrations

Manual QbD in pharma creates delays, errors, and frustrations. Discover how digital QbD frameworks enhance efficiency, accuracy, and compliance in drug development.

AI-powered CQV illustration with handshake, gears, and data dashboard for audit readiness.

Audit Pressure? Stop Last-Minute Scrambles  With AI-Powered CQV

Discover how adopting a risk-based, AI-powered approach to CQV can streamline audit readiness, reduce stress, and ensure compliance in pharmaceutical manufacturing.

Illustration showing the risks of manual cleaning validation in pharma, with FDA 483 warning, checklists, and digital dashboards

Why Modernizing Cleaning Validation Is Crucial for Compliance

Learn why cleaning validation in pharma is under regulatory scrutiny and how replacing manual processes with digital tools strengthens compliance.

Side-by-side illustration of a worried person with papers and a confident person holding a tablet with charts, symbolizing tech transfer inefficiencies vs. digital solutions.

How Inefficiencies in Tech Transfer Drive Up Costs (And What to Do About It)

Discover how inefficiencies in tech transfer in pharma increase costs and delays—and how digital tools help reduce both cost and risk.

Illustration of a stopwatch, data dashboard with charts, and a bioreactor vessel, representing automation and data monitoring in equipment qualification workflows

From Weeks to Minutes: How Intelligent Automation Transforms CQV Workflows

Discover how intelligent automation transforms CQV workflows and streamlines equipment qualification in pharma—cutting costs, time, and risk.

All Tags

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

The Benefits of Automating Your Requirements Traceability Matrix

Catalent's Journey of Continuous Improvement for CSV Excellence

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

Why Cleaning Validation Still Tops FDA 483 Observations

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

Validating Pharma 4.0 for Smart Manufacturing

The X Factor for Successful Digital Transformation in BioPharma: People

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. 

newsletter