For decades now, computer system validation (CSV) has revolved around the thump factor. The more validation paperwork you have, the louder the thump when you drop it in front of an inspector, the better your validation process. At least, that was the thinking. The problem was that all that effort, all that thump, didn’t provide a lot of value to the regulators, the businesses or their customers. Traditional CSV is basically busy work.
Fortunately, the U.S. Food and Drug Administration (FDA) recognized this and started encouraging companies to take a risk-based approach to their software validation. Instead of the traditional CSV model which rests heavily on documentation, the anticipated computer software assurance (CSA) guidance rests heavily on critical thinking. Tools that are based on this guidance greatly reduce the validation burden, reducing the time needed to hours or minutes for change control.
The future of validation is even more streamlined. That’s because self-validating software is now a possibility. The cloud is the norm instead of the exception, which means more frequent releases. And if a software as a service company adopts an agile approach to their development, feature releases become even more frequent. Keeping up with the latest improvements means using a validation approach that takes a business’s usage into consideration and can automatically validate with no involvement from the user.
• Key takeaways from this session include:
• Why and how traditional CSV holds companies back.
• How to implement a risk-based approach for your company.
• How self-validating software is possible and practical for the life sciences.
Erin Wright Bio:
As MasterControl’s senior product manager over validation and Insights, Erin Wright spearheads the efforts pertaining to the development of the company’s groundbreaking Validation Excellence Tool (VxT). She holds a patent related to streamlining the validation process by using a risk-based approach to greatly reduce validation time, with a second patent pending. She created and implemented the configuration-based testing that drives the VxT and is currently working to develop self-validating capabilities in MasterControl software.
She joined MasterControl in 2013 as a professional services consultant and worked closely with hundreds of regulated companies, including the FDA’s Center for Drug Evaluation and Research (CDER). Her extensive experience in quality, validation, and regulatory compliance includes working for an automated-testing software company and several clinical-trial software providers.