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Avoiding Common FDA 483 Observations in Cleaning Validation

Sep 5, 2024 10:15:00 AM | Learn to avoid FDA 483 observations in cleaning validation to ensure patient safety and product efficacy. Protect your business with these actionable strategies.

Posts about Cleaning Validation:

An illustration of a hand wiping down laboratory equipment. The FDA 483 warning label is displayed in the foreground.

Avoiding Common FDA 483 Observations in Cleaning Validation

Learn to avoid FDA 483 observations in cleaning validation to ensure patient safety and product efficacy. Protect your business with these actionable strategies.

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?

Explore the regulatory expectations for cleaning validation, the challenges faced, and how ValGenesis Process Manager can help you simplify compliance.

Best Practices for Impact Assessments in Cleaning Validation

Explore best practices for impact assessments in cleaning validation, including strategies for using technology to streamline the assessment process.

cleaning validation of equipment

Five Cleaning Validation Challenges Digitalization Solves

This post examines five cleaning validation challenges that can be eliminated by digitizing your cleaning validation approach with ValGenesis.

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

ValGenesis Process Manager can help life sciences companies avoid FDA 483s and establish a harmonized cleaning validation program companywide.

Maximize the Use of Technology to Access Real-Time Clean In Place Data

ValGenesis validation lifecycle management systems provide a solution that eliminates all the inefficiencies that plagued paper-based cleaning validation processes.

Cleaning Validation Stage 1: On a Quest for Process Understanding

Want to learn more about cleaning validation? The use of data collection, analysis, and evaluation are the most critical tasks in a cleaning validation program.

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.

Cleaning Validation Stage 3: Continued Process Verification

Stage 3, CPV, encompasses validation maintenance or verification that the qualified cleaning process continues to perform consistently.

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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.

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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

What are the Regulatory Expectations for Cleaning Validation?

Best Practices for Impact Assessments 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.

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The Pharma 4.0 Vision for Manufacturing Intelligence

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