The Next Generation of Software Validation: Self-Validating Software

Register Free: https://www.biopharminternational.com/bp_w/software

Event Overview:

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 business 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.

• Traditional software validation is tedious, time consuming and often inhibits companies from upgrading their software.
• The move from CSV to CSA. Moving from heavy documentation to critical thinking.
• The future of validation is more streamlined. Using a risk-based approach, companies can focus validation on the areas of greatest risk.
• Stay current with the latest software tools.

Key Learning Objectives:

• 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.

Who Should Attend:

• Quality Managers and Directors
• Manufacturing Managers and Directors
• IT Managers and Directors
• Especially those who work with computer software technology and must validate.
• CEO

Speakers

Erin Wright
Director, Product Management
MasterControl

Register Free: https://www.biopharminternational.com/bp_w/software