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
Using ValGenesis iRisk for Better CMC Process Development
May 30, 2024 10:00:00 AM | Explore how ValGenesis iRisk enhances pharma process development through QbD principles, promoting regulatory compliance, efficiency, and patient safety.
Using ValGenesis iRisk for Better CMC Process Development
Explore how ValGenesis iRisk enhances pharma process development through QbD principles, promoting regulatory 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.
How Integrating Risk Assessment and CPV Increases Patient Safety
Learn how integrating risk assessment and CPV with cutting-edge technology can dramatically improve patient safety and future-proof quality standards.
Real-Time Monitoring: Why Have It and How to Get It
Discover the importance of real-time process monitoring in pharma manufacturing. Explore how RTM enhances efficiency, quality, and compliance.
Best Practices for Impact Assessments in Cleaning Validation
Explore best practices for impact assessments in cleaning validation, including strategies for using technology to streamline the assessment process.
Optimizing Your Annual Product Quality Reviews
Learn how to optimize annual product quality reviews (APQRs) to ensure regulatory compliance, product quality, and continuous improvement.
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.
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.
Let's Move Beyond Spreadsheets for Risk Management
Discover why Excel is no longer sufficient for effective risk management in the pharma industry and why transitioning to specialized software is crucial.
Best Practices in Commissioning and Qualification ― Part Two
Discover best practices for integrating your commissioning and qualification processes and how to streamline C&Q activities with robust digital solutions.
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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.
Is Your Cleaning Validation Stuck in the Slow Lane?
Discover what cleaning validation is in pharma, why it's required, and how digital tools help you meet FDA cleaning validation guidelines efficiently.
Previously
Cleaning Validation Program Compliance: Build a Framework for Success
Equipment Design in Cleaning Validation: Enhancing Your Sampling Plan
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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