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
Should e‑Logbook Software Work Offline? Yes, Here's Why.
Feb 22, 2024 10:00:00 AM | Electronic logbook software that doesn't work offline deprives you of valuable functionality. ValGenesis e-Logbook is mobile-ready for offline execution.
Posts about Electronic Logbook Management:
Should e‑Logbook Software Work Offline? Yes, Here's Why.
Electronic logbook software that doesn't work offline deprives you of valuable functionality. ValGenesis e-Logbook is mobile-ready for offline execution.
Why You Should Transition from Pen/Paper to Digital Logbooks
Discover the benefits of digital logbooks and why they are a cost-effective and manageable first step toward broader digital transformation initiatives.
FDA Warning Letters Expose the Risks of Using Paper Logbooks
Examples from real FDA warning letters show the risks and consequences of using paper logbooks and why a digital logbook management solution is essential.
Tablet Computing in GMP Environments: Flashy Gadget or Useful Tool?
This post examines four reasons tablet computers are ideal for validating computer systems, equipment, and instruments in controlled GMP manufacturing environments.
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.
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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.
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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 ...
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