Insight and opinion

2023 State of Validation Survey: Share Your Voice

Navigating the evolving regulatory landscape requires an informed, efficient, and effective validation program. To help companies achieve this, we sponsor…

The True Cost of Delaying Digital Transformation in Validation

Starting a digital transformation can seem daunting, but the cost of delaying it is far worse. Learn why you should start your digital validation journey today.

Why Digital Maturity in Manufacturing Underpins Commercial Performance

Digital maturity in manufacturing is an increasingly important aspect of commercial performance in the life sciences industry today. In this…

How Kneat Meets 21 CFR Part 11 and Unlocks Additional Benefits

As life sciences manufacturers continue to seek efficiencies in processes through computer systems, demand to install and maintain an array…

5 Things You Need to Know About Computer Software Assurance (CSA)

The Computer Software Assurance for Production and Quality System Software draft guidance stems from a multi-year collaboration between the FDA…

How to Communicate the Value of Digital Validation to Your Business

Critical to the success of implementing a digital validation solution, is the ability to communicate its business and financial benefits,…

How to Build a Successful Budget for Digital Validation

A project budget is a detailed calculation of financial costs from initial concept, across key project milestones, to the completion…

VALIDATE: Announcing VALIDATE EU 2023, and a Look Back at the Highlights and Insights of VALIDATE 2022

The first-ever VALIDATE conference has now been and gone, but we’re excited to announce VALIDATE EU 2023 is coming, April…

Top Priorities for Validation Teams in 2023

The State of Validation survey asked validation leaders to define their major priorities for 2023, with some interesting results! Understand…

Kneat 2022: Year in Review

As a new year begins it’s a time to reflect on the year that’s passed, and what an incredible year…

Three Key Validation Trends in 2023

No industry stays completely the same year over year, even one as cautious in change as the validation industry. In…

Best Practices to Achieve Computer Software Assurance with Digital Validation: FAQ

The U.S. FDA is encouraging life sciences manufacturers to adopt a risk-based approach in assessing production and quality software. The…

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