Risk-based CSA Validation: Ensuring the Least Burdensome Approach
The post summarizes the key principles of CSA, various testing methodologies, risk management, and the benefits of digital software validation tools.
Latest News
Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes
May 12, 2023 4:18:49 AM | ValGenesis Process Manager can help life sciences companies avoid FDA 483s and establish a harmonized cleaning validation program companywide.
Posts about Cleaning Validation:
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 Pain Points & How to Solve Them Through Digitization
This post examines three common pain points that can be alleviated (or even eliminated) by digitizing and automating cleaning validation processes.
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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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.
Written by
Sofia Santos
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.
Written by
Sofia Santos
Quality Risk Management
Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis
Read the industry insight on the topic of Quality Risk Management
Presented by
Sandra Silva
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
Embracing Change: The Transition from CSV to CSA in Pharmaceuticals
How to Overcome the Subjectivity of Objective Evidence in FDA Audits
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.
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.
Previously
Maximize the Use of Technology to Access Real-Time Clean In Place Data
Cleaning Validation Stage 1: On a Quest for Process Understanding
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.
The X Factor for Successful Digital Transformation in BioPharma: People
This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising ...
Previously
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