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

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

Feb 22, 2024, 10:00:00 AM | Logbook management software that doesn't work offline deprives you of valuable functionality. ValGenesis iOps is mobile-ready for offline execution.

All Blog Posts

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.

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.

Best Practices for Process Validation in the Pharmaceutical Industry

Learn best practices for process validation in the pharma industry. Find out how digitalization streamlines validation operations and improves product quality.

Build an Effective Data Integrity Program with Risk Management

Understand why data integrity problems occur, and learn how to build an effective, risk-based corporate data integrity program to address them.

Using Digital Twins to Modernize Equipment Qualification

Is digital twin technology the key to achieving compliant, efficient equipment qualification in the modern life sciences manufacturing industry?

Types of Validation in the Pharmaceutical Industry

All systems, equipment, and processes that have GxP impact require validation. Here are the different types of validation in the pharmaceutical industry.

Six Best Practices for Alcoa Data Integrity

Learn about the significance of ALCOA+ in maintaining data integrity in the pharma industry and best practices for implementing ALCOA+ principles.

Document with electronic signature and security controls for FDA 21 CFR Part 11 compliance: electronic records and signatures.

What is FDA 21 CFR Part 11 Compliance?

Learn about FDA 21 CFR Part 11 compliance and the regulatory requirements for electronic records and signatures in the life sciences industry.

FDA Warning Letters Expose the Risks of Using Paper Logbooks

Examples from real FDA warning letters show the risks and consequences of using paper logbooks and why a digital logbook management solution is essential. 

Illustration showing paperless validation transition from paper documents to digital workflows with connected data and compliance tracking

What Is Paperless Validation All About?

In this post, we'll explore the transition to paperless validation and the benefits it brings such as efficiency, cost reduction, and compliance assurance.

Risk-based CSA Validation: Ensuring the Least Burdensome Approach

The post summarizes the key principles of CSA, various testing methodologies, risk management, and the benefits of digital software validation tools.

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.

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.

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).

Digital checklist with checkmark indicating validated requirements and CSA/CSV compliance readiness.

Requirements Management 101: Tips for Writing Good Requirements

Learn how to write clear, defensible requirements and use Agile methodology and structured qualifiers to strengthen traceability in CSV and CSA.

Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

Quality Risk Management

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

Tech Transfer & Process Scale-up

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

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.

Previously

Funding Cleaning Validation Before the Next Investigation

Cleaning Validation Limits Explained: HBEL/MACO, 10 ppm, and 'Visually Clean'

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.

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