Blog

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

Can Blockchain Technology Boost  Data Integrity in Clinical Trials?

Aug 3, 2023 11:00:00 AM | Blockchain technology is revolutionizing how data integrity is ensured in clinical trials, establishing a new level of trust and compliance.

Can Blockchain Technology Boost  Data Integrity in Clinical Trials?

Blockchain technology is revolutionizing how data integrity is ensured in clinical trials, establishing a new level of trust and compliance.

3 Huge Benefits of Integrating Process Data with Risk Management

In this post, we’ll look at 3 benefits of integrating process data with risk management and how it increases organizational efficiency and competitiveness.

How to Overcome the Subjectivity of Objective Evidence in FDA Audits

How do we deliver objective evidence with a high degree of certainty it will withstand regulatory scrutiny? Technology tools like a VLMS hold the answer.

Are You GMP Annex 1 Revision Ready?

Learn about the requirements of the Annex 1 revision and how to ensure compliance with a digital risk management platform.

Saving Time and Resources with CSA

In this blog post, we will explore how making your transition from the traditional CSV to the new CSA approach can save you time and resources.

Decentralized Clinical Trials: Why Digitization is a Must

Sponsors and CROs are prioritizing digitization to build a foundation for decentralized clinical trials and using AI/ML tools to improve patient outcomes.

It's Time to Implement ICH Q9(R1)

In this blog post we'll look into what steps you may need to take to make sure you are compliant with the ICH Q9(R1) guideline.

Enhancing Continuous Manufacturing with Digital CPV Integration

Learn how implementing digital CPV plans can contribute to continuous processes reaping the benefits of Industry 4.0 and digitalization.

How Spreadsheets Create Compliance Risks: An Auditor's Perspective

Spreadsheet tools like Excel raise a regulatory red flag and can trigger an audit. Your best defense is a validation lifecycle management system (VLMS).

Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes

ValGenesis Process Manager can help life sciences companies avoid FDA 483s and establish a harmonized cleaning validation program companywide.

All Tags

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

Leveraging Vendor Testing: A Smarter Approach to Validation

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

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

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.

Previously

The X Factor for Successful Digital Transformation in BioPharma: People

The Pharma 4.0 Vision for Manufacturing Intelligence

High-quality Content Straight to Your Inbox!

Join our newsletter to receive updates on the latest news and industry-related content tailored to your preferences. 

newsletter