Out-of-the-Box Computer Software Assurance with ValGenesis
Simplify your transition to computer software assurance (CSA) with ValGenesis VLMS. Discover key features that streamline your validation processes.
Latest News
Electronic Logbooks: Leveraging the Power of Business Rules
Apr 4, 2024 10:00:00 AM | ValGenesis e-Logbook uses business rules to enforce SOPs and standardize log activities, improving decision-making, productivity, and data integrity.
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.
Best Practices in Commissioning and Qualification ― Part One
Learn best practices for implementing an integrated commissioning and qualification approach and the 5 critical elements to include in your C&Q plan.
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.
Better Tech Transfers: A Digital Transformation Approach
Learn about rising drug development costs, the role of CDMOs, and how a digital-first strategy can revolutionize tech transfer in the pharma industry.
6 Ts to Drive Computer Software Assurance Adoption
Explore what's needed to successfully adopt the FDA's computer software assurance (CSA) guidance in your life sciences company.
Commissioning and Qualification in Pharma: An Overview
Learn about commissioning and qualification in pharma. Understand the processes involved and the regulatory guidelines to ensure product quality and safety.
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.
Previously
Requirement-Level Risk Assessment: A Game-Changer in Validation
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.
How Can Digital Cleaning Validation Improve Product Changeover Safety?
Learn how digital cleaning validation solutions can prevent cross-contamination and ensure drug safety during product changeovers in pharma manufacturing.
Previously
Avoiding Common FDA 483 Observations in Cleaning Validation
What are the Regulatory Expectations for Cleaning Validation?
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.
Validating Pharma 4.0 for Smart Manufacturing
Explore how Pharma 4.0 leverages advanced technologies to revolutionize pharmaceutical manufacturing, enhancing efficiency, quality, and patient-centric outcomes.
Previously
The X Factor for Successful Digital Transformation in BioPharma: People
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