The rigidly comprehensive CSV (Computer Software Validation) model and its tedious testing and documentation have finally given way to a risk-based CSA (Computer Software Assurance) approach. It’s an improvement, but this doesn’t mean validation is easy to execute or document.
fme compliance-center is here to solve that challenge.
Remove validation-related barriers
The validation costs required when upgrading systems in a Life Sciences firm have put digital transformation initiatives out of reach for many. While CSA is intended to minimize this barrier, leveraging a CSA-based approach requires businesses to assess risks and apply appropriate testing steps when performing validation of systems. fme compliance-center delivers a complete end-to-end solution to address these needs.
fme compliance-center streamlines validation
Based on the CSA guidelines and our 25 years of working with global pharmaceutical and medical firms, fme compliance-center is specifically built to streamline validation workflows. With an intuitive interface and clear instructions, the solution walks you through each validation process step, providing detailed guidance on when you can take advantage of CSA, when traditional CSV is required, and when a hybrid approach is possible.
In the end, fme compliance-center saves users time and money, and implements solutions quicker while delivering a higher quality product.
Learn more about fme compliance-center
Join fme’s validation experts for an in-depth introduction to our newest solution that delivers fit-for-purpose QMS capability for companies in a paperless cloud platform. We’ll demonstrate how fme compliance-center:
- Drives the risk assessment process to determine the appropriate testing levels
- Provides the tools and templates to conduct the testing
- Automates the document management and reporting activities
We’ll also show how our CSA-based guidelines help you organize, execute, and document your critical validation tasks in an easy to understand dashboard that connects your people, processes, and content across your business.
Reserve your spot today to ensure you receive the full recording to share with your team!
fme compliance-center: Validation at the speed of business
Date: Wednesday, May 31, 2023
Time: 10am EDT
Learn more about CSV and CSA
Learn more about the challenges and new solutions for software validation in this recording from fme’s David Gwyn.