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FDAs Computer Software Assurance (CSA) – Part 3 of 3

Apr 20, 2023 10:27:57 AM | The efficiencies gained, according to ValGenesis customers, range from 50% to 80% improvements. This lessens demand and allows more time to be focused on higher priority tasks. Knowing the ValGenesis VLMS ensures controls and standards are followed, according to customer-specific requirements, stakeholders are given a high-degree of assurance that Quality is ingrained in the process.

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FDAs Computer Software Assurance (CSA) – Part 3 of 3

The efficiencies gained, according to ValGenesis customers, range from 50% to 80% improvements. This lessens demand and allows more time to be focused on higher priority tasks. Knowing the ValGenesis VLMS ensures controls and standards are followed, according to customer-specific requirements, stakeholders are given a high-degree of assurance that Quality is ingrained in the process.

How to Align Analytical QbD With the new ICH Q14?

How to connect already existing AQbD with the new ICH Q14? Jean-François Dierick and Claudia Magagnoli from GSK explained us how!

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)

Does Quality Culture Affect pQMS Outcomes? Absolutely.

This post examines the crucial impact quality culture has on individuals, organizations, and processes; it offers tips for improving it in your company.

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.

How to Design a Control Strategy for Analytical Procedures

An efficient control strategy will ensure your processes performs always as expected. In this blog post we described the steps to design one.

A new Approach for Biosimilarity Assessments: a ValGenesis Story

This a story about how we helped a company with their biosimilarity assessments and to avoid massive time-to-market delay!

Maximize the Use of Technology to Access Real-Time Clean In Place Data

ValGenesis validation lifecycle management systems provide a solution that eliminates all the inefficiencies that plagued paper-based cleaning validation processes.

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)

Comparability for Post-Approval Changes

Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.

Finding a Root-cause in a Filter Clogging at Drug Product Filtration

This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.  

Cleaning Validation Stage 1: On a Quest for Process Understanding

Want to learn more about cleaning validation? The use of data collection, analysis, and evaluation are the most critical tasks in a cleaning validation program.

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.

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

Change Impact Assessments in ValGenesis iClean™: A Framework for Consistency

Unlocking Operational Capacity with Fully Digitalized 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.

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