The Benefits of Automating Your Requirements Traceability Matrix
Automate your requirements traceability matrix to improve efficiency, reduce compliance risks, and streamline validation for better audit readiness.
Latest News
Avoid FDA 483 Observations with Digital Logbook Precision
Jan 9, 2025 10:25:11 AM | Minimize FDA 483 observations and boost compliance with digital logbooks. Transform your documentation processes and reduce risk with ValGenesis e-Logbook.
Posts about Electronic Logbook Management:
Avoid FDA 483 Observations with Digital Logbook Precision
Minimize FDA 483 observations and boost compliance with digital logbooks. Transform your documentation processes and reduce risk with ValGenesis e-Logbook.
Access Your Logbook Data Instantly with ValGenesis e‑Logbook
Transform your logbook data into a strategic asset with ValGenesis e-Logbook for enhanced compliance, decision-making, and operational efficiency.
Mastering Equipment Hold Time Controls with Electronic Logbooks
Optimize pharma manufacturing with ValGenesis e-Logbook for automated clean/dirty hold time management. Ensure compliance, efficiency, and patient safety.
Maximize Operational Efficiency with ValGenesis e‑Logbook
Revolutionize pharma operations with ValGenesis e-Logbook. Streamline data entry, enhance compliance, and drive efficiency in manufacturing processes.
Electronic Logbooks: Leveraging the Power of Business Rules
ValGenesis e-Logbook uses business rules to enforce SOPs and standardize log activities, improving decision-making, productivity, and data integrity.
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.
Previously
Catalent's Journey of Continuous Improvement for CSV Excellence
Are You Aligned with FDA's Computer Software Assurance Methodology?
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.
Cleaning Validation Program Compliance: Build a Framework for Success
Streamline operations and ensure compliance with a digital cleaning validation framework. Discover strategies to enhance efficiency and tackle challenges.
Previously
Equipment Design in Cleaning Validation: Enhancing Your Sampling Plan
How Can Digital Cleaning Validation Improve Product Changeover Safety?
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.
Catalent's Journey of Continuous Improvement for CSV Excellence
Learn how Catalent scaled CSV compliance with ValGenesis VLMS to enhance global IT operations.
Previously
Validating Pharma 4.0 for Smart Manufacturing
The X Factor for Successful Digital Transformation in BioPharma: People
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