Guide to Buying COTS Software - How to Audit and Evaluate Vendors

• By: Staff Editor
• Date: August 06, 2018

When the internet was not as ubiquitous as it is today, Life Sciences Companies maintained documents manually. Submitting truckloads of paper records to the FDA was a norm when the U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 back in 1997.

With the evolution of the internet, more companies joined the inevitable movement toward the use of electronic systems. This article is a ready reckoner for Companies that are looking to buy COTS (Commercial Off-The-Shelf) software to automate their document and business process management. It guides buyers through the process and helps Companies maintain constant inspection readiness.