fme compliance center: Validation at the speed of business

by The fme Team |
May 18, 2023 |

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!

Webinar Details

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. 


I’m here to help

Contact us to get more details on any of fme’s services. We’d love to discuss your current challenges, and how fme can help you get the highest ROI and lowest TCO for your technology solutions. Call or use my contact form with your question, and get you connected with the right fme expert.

fme is always looking for top talent to join our team. If you are looking to join the team you’ll love to work with, review our job listings and review the details of current openings. Contact me if you have any questions on the application process.

Tracey King
Technology Success Manager