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
Are You Aligned with FDA's Computer Software Assurance Methodology?
May 5, 2022 12:00:00 PM | CSA is achievable under current regulation. If you’re following these 3 core CSV principles, odds are you’re already aligned with the new CSA methodology.
Are You Aligned with FDA's Computer Software Assurance Methodology?
CSA is achievable under current regulation. If you’re following these 3 core CSV principles, odds are you’re already aligned with the new CSA methodology.
Accelerate Time-to-market Using a QbD Framework: a ValGenesis Story
We write about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework
ROI Study: Digitizing Validation Yields 50% Overall Efficiency Gain
ROI study reveals how much time and money customers save by digitizing corporate validation processes. Watch the webinar (link in post).
The Challenges of Paper-Based Logbook Management and How to Avoid Them
When manufacturers rely on paper-based logbooks, they expose themselves to human errors, poor data integrity, and a host of compliance risks.
How Emerging Technologies are Revolutionizing Validation Methods
Technologies like blockchain, AI, ML, and AR have the potential to revolutionize validation methods and catalyze companies transitioning to Pharma 4.0.
The Benefits of Automating Your Requirements Traceability Matrix (RTM)
Manual requirements traceability matrix generation is error-prone and costly due to the resources and time required to maintain them during the validation lifecycle.
ValGenesis Podcast on Virtual Inspections Wins Podcast of the Year
"Digitization Of Validation For Effective Virtual Regulatory Inspections" wins IVT's Voices in Validation 2021 Podcast of the Year Award. Read transcript.
Cleaning Validation Stage 3: Continued Process Verification
Stage 3, CPV, encompasses validation maintenance or verification that the qualified cleaning process continues to perform consistently.
“No Paper” is Only 25% of the Benefit of “Paperless” Validation
Saving bottom-line costs of paper and paper storage is just one benefit of paperless validation. Also at stake: disaster recovery, using big data intelligently, and keeping remote teams productive.
Digitize Validation for Remote Regulatory Reviews and Inspections
Paperless validation lifecycle management systems empower regulators to conduct effective off-site regulatory reviews and inspections.
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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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