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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.

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What Is Paperless Validation All About?

Oct 26, 2023, 3:29:36 PM | In this post, we'll explore the transition to paperless validation and the benefits it brings such as efficiency, cost reduction, and compliance assurance.

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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.

Generative AI and Its Impact on Validation: Part 2

This post is the second installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.

Generative AI and Its Impact on Validation: Part 1

This post is the first installment of a two-part series on the incredible impact of generative AI, particularly ChatGPT, on validation in the life sciences.

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.

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).

12 Reasons to Transition to a Digital Validation Process, Part 2

Paper-based workflows have been the industry standard for validating systems and processes. But companies gain many benefits from going digital. (Part 2 of 2)

What's the Difference Between a VLMS and a DMS?

If you think of validation as a pie, document authoring is 25% of the pie. A DMS can’t address the other 75% of validation activities ValGenesis supports.

Object-Oriented Validation: A Different Way of Thinking

ValGenesis (VLMS) has capitalized on delivering functionality to support object-oriented validation. Here you can create requirements as objects, and these can be shared.

User Requirements Specification: Creating one for CSA

This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.

Twelve Reasons to Transition to a Digital Validation Process, Part 1

Pharma has embraced digitization in many business lines, but validation has been one of the few processes to remain manual. Here are 12 reasons to make the switch! (Part 1 of 2)

Top 10 Benefits of ValGenesis Paperless Validation

Explore the top 10 business benefits you'll receive from digitizing your paper-based validation processes with ValGenesis.

How Can CSA Simplify Your Validation Processes

A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.

The Benefits of a Cloud-Based Digital Validation System

Cloud-based digital validation allows you to recover in the event of a disaster, ensuring business continuity and compliance.

How to Improve Business Efficiency With Digital Validation

In this blog post, we show you how digital validation can improve your validation process and enhance your business efficiency.

Tablet Computing in GMP Environments: Flashy Gadget or Useful Tool?

This post examines four reasons tablet computers are ideal for validating computer systems, equipment, and instruments in controlled GMP manufacturing environments.

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

ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences

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

Dirty and Clean Hold Times: Setting Defensible Limits for Cleaning Validation

Funding Cleaning Validation Before the Next Investigation

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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