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How to Audit Software Vendors: Execution
October 23, 2024Welcome to Part 2 of our series on how to audit software vendors. We will focus on the main event – doing the inspection...
Are you ready for the FDA guidance on Data Integrity and Compliance?
September 23, 2024The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is...
3 Reasons for Auditing Software Vendors
July 06, 2020Regulatory Agencies, like the FDA and Eudralex require companies to audit software vendors of their critical software an...
8 Regulatory Expectations for Purchased Systems
August 17, 2018If you have purchased or are planning to purchase a computer system for use in regulated activities, here are some key p...
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...
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 – 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...
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...