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Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.

Latest News

Maximize Operational Efficiency with ValGenesis e‑Logbook

May 23, 2024 11:52:00 AM | Revolutionize pharma operations with ValGenesis e-Logbook. Streamline data entry, enhance compliance, and drive efficiency in manufacturing processes.

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Yellow sign on blue background with text saying improved operational efficiency

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.

Illustration of interconnected gears, with icons representing uniting risk assessment with continued process verification cpv

How Integrating Risk Assessment and CPV Increases Patient Safety

Integrating risk assessment and continued process verification with digital technology enhances patient safety and optimizes processes in the pharma industry.

Real-Time Monitoring in Pharma: Why It Matters and How to Get It Right

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 (APQRs)

Explore how digital transformation in pharma manufacturing enables continuous process verification and data-driven quality insights for better APQRs.

Man using electronic logbook software on laptop

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.

Intersecting circle diagram linking CSA guidance to GAMP 5

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.

Excel spreadsheet with overlay screenshot of ValGenesis risk management platform

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.

Cloud sync illustration showing online and offline access for digital logbook management software

Should e‑Logbook Software Work Offline? Yes, Here's Why.

Logbook management software that doesn't work offline deprives you of valuable functionality. ValGenesis iOps is mobile-ready for offline execution.

Pharma worker recording calibration data to a paper equipment log form

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.

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Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

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.

Sofia Santos

Written by
Sofia Santos

How to Accelerate Process Scale-Up With Effective Tech Transfer

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.

Sofia Santos

Written by
Sofia Santos

Risk-Based Cleaning Validation: A Lifecycle Approach

Cleaning Validation

Risk-Based Cleaning Validation: A Lifecycle Approach

Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.

Kenneth Pierce

Written by
Kenneth Pierce

Trending Topics With ValGenesis Customers

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

The Benefits of Automating Your Requirements Traceability Matrix

Catalent's Journey of Continuous Improvement for CSV Excellence

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.

Previously

The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks

Digital Cleaning Validation: From Lifecycle Control to Real-Time Assurance

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.

Previously

Catalent's Journey of Continuous Improvement for CSV Excellence

Validating Pharma 4.0 for Smart Manufacturing

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