How Do the FDA's CSA Guidance and 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.
Latest News
ValConnect 2022 Session Round-Up: Building a Digital-First Culture
Oct 17, 2022 10:30:00 AM | Digitalization and the Pharma 4.0 vision appeals to young generation engineers from ‘career development’ and ‘cultural engagement’ perspectives.
ValConnect 2022 Session Round-Up: Building a Digital-First Culture
Digitalization and the Pharma 4.0 vision appeals to young generation engineers from ‘career development’ and ‘cultural engagement’ perspectives.
ValConnect 2022 Session Round-Up: Are Quality & Compliance the Same?
The evolution from compliance to a proactive learning system focused on patient quality outcomes involves overcoming several barriers, says FDA.
Greenfield CDMO Sees Digital Validation as a Competitive Advantage
Faster innovation and time to market are top priorities for CDMOs. Being a digital-first organization gives Theragent a substantial competitive advantage.
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.
All Tags
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.
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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.
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.
Previously
Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes
Maximize the Use of Technology to Access Real-Time Clean In Place Data
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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