CSV and CSA FAQs: Practical Answers for Life Sciences Validation Teams
Get practical answers about CSV, CSA, risk-based testing, assurance needs, documentation, requirements, and ValGenesis support for software validation.
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.
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.
In this post, we'll explore the transition to paperless validation and the benefits it brings such as efficiency, cost reduction, and compliance assurance.
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.
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 do we deliver objective evidence with a high degree of certainty it will withstand regulatory scrutiny? Technology tools like a VLMS hold the answer.
Spreadsheet tools like Excel raise a regulatory red flag and can trigger an audit. Your best defense is a validation lifecycle management system (VLMS).
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)
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.
ValGenesis (VLMS) has capitalized on delivering functionality to support object-oriented validation. Here you can create requirements as objects, and these can be shared.
This post is about tips to write your User Requirements Specification and how it can improve your processed data and software.
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)
Explore the top 10 business benefits you'll receive from digitizing your paper-based validation processes with ValGenesis.
A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.
Cloud-based digital validation allows you to recover in the event of a disaster, ensuring business continuity and compliance.
In this blog post, we show you how digital validation can improve your validation process and enhance your business efficiency.
This post examines four reasons tablet computers are ideal for validating computer systems, equipment, and instruments in controlled GMP manufacturing environments.
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.
Written by
Sofia Santos
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.
Written by
Sofia Santos
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.
Written by
Kenneth Pierce
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.
Get practical answers about CSV, CSA, risk-based testing, assurance needs, documentation, requirements, and ValGenesis support for software validation.
Previously
ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences
Catalent's Journey of Continuous Improvement for CSV Excellence
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.
Explore practical FAQs on cleaning validation in pharma, including regulatory expectations, limits, lifecycle stages, sampling, change control, and digital execution.
Previously
Dirty and Clean Hold Times: Setting Defensible Limits for Cleaning Validation
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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