Validation Center
Computer System Validation News
History of 21 CFR 11 Compliance
April 17, 2018Life Sciences companies that want to sell their products or services in the United States must comply with the 21 CFR Pa...
What is Computer System Validation and How Do You Do It?
April 11, 2018Computer System Validation (CSV) is often referred to as software validation. Regulated companies perform validation pro...
6 Steps to Prepare for an FDA Inspection (Don't Leave it to Chance)
November 20, 2017The FDA called. They’re coming to do an inspection. Yikes! Now what? How do you prepare? We’ve been there. We’ve experie...
How to Audit Software Vendors: Part 3
October 23, 2017Today is Part 3, the final post of our series – How to Audit Software Vendors. This post will review three examples of h...
How to Audit Software Vendors: Part 1 - Audit Preparation
October 10, 2017Welcome to our three part series on how to audit software vendors. In part one, we’ll review the basic processes and pre...
How to Audit Software Vendors – Which Method is Right for You?
May 10, 2017How do you audit a software vendor? Which is the right method for your company? These are some questions you may be aski...
The Key To Successful Software Vendor Assessments (Hint: It's A Checklist!)
February 20, 2017How do you choose a software vendor? And once you do, will they be able to keep you compliant? Which vendor will provide...
Warning Letter Roundup - January 2017
January 12, 2017The FDA sends Warning Letters and 483s to companies who significantly violate FDA regulations. We gather those related t...
How Are You Managing Your Postmarket Cybersecurity Vulnerabilities For Medical Devices?
January 05, 2017At the end of 2016, the FDA published Guidance for Industry and FDA Staff, Postmarket Management of Cybersecurity in Med...
Warning Letter Roundup - December 2016
December 19, 2016The FDA sends Warning Letters and 483s to companies that significantly violate FDA regulations. We gather those related ...