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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

How Integrating Risk Assessment and CPV Increases Patient Safety

May 16, 2024 10:00:00 AM | Learn how integrating risk assessment and CPV with cutting-edge technology can dramatically improve patient safety and future-proof quality standards.

Illustration of a faceless person pointing at interconnected gears, with icons representing uniting risk assessment with CPV in the pharma industry

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.

 Eight icons showcase real-time monitoring (RTM) in pharmaceutical manufacturing, emphasizing its role in optimizing efficiency, quality, and compliance throughout the process.

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.

Life sciences professional behind a pile of APQR binders, hand pointing to dashboard in process lifecycle software

Optimizing Your Annual Product Quality Reviews

Learn how to optimize annual product quality reviews (APQRs) to ensure regulatory compliance, product quality, and continuous improvement.

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.

Commissioning and qualification of GMP facility

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.

GMP equipment qualification

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.

Pharma tech using tablet to execute GMP log form on mobile app

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.

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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 and Data as Knowledge Enablers: A Lifecycle Approach

Quality Risk Management

Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis

Read the industry insight on the topic of Quality Risk Management

Sandra Silva

Presented by
Sandra Silva

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

Out-of-the-Box Computer Software Assurance with ValGenesis

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.

Previously

How Can Digital Cleaning Validation Improve Product Changeover Safety?

Avoiding Common FDA 483 Observations in 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.

Previously

The X Factor for Successful Digital Transformation in BioPharma: People

The Pharma 4.0 Vision for Manufacturing Intelligence

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