Celia Brown
By Celia Brown on March 05, 2020

How to Properly Audit a Vendor in a Regulated Environment

eQMS,
QLF,

christina-wocintechchat-com-sjO_VsSkN9s-unsplashAuditing a vendor starts long before you actually step into their office to perform the audit. For example, one of the first things you should look for when selecting a vendor is how willing they are to offer customers access to their platform- that may include performing demos of their solution, providing a sandbox environment or free trial, and responding to questions/ inquiries. 

When selecting a software solution for a life sciences or other regulated environment, it is also important to determine if the vendor is compliant with specific regulatory requirements. And do they have the right infrastructure to meet your business needs- do they host the solution on-premise or in the cloud? 

It is also critical that you investigate if the vendor has a quality management system (QMS) in place and are they using it consistently and effectively to manage their own documents, training, and processes. According to Sourav (Neil) Banerjee, Principal Consultant at QMS Integrity, “If your company is inspected by a regulatory agency tomorrow, it is important that you have confidence in the vendor’s ability to produce the right kind of records regarding things like computer systems, disaster recovery, and business continuity plans.” 

Learn more about how to properly audit a vendor in this video featuring Sourav (Neil) Banerjee>>

 

Published by Celia Brown March 5, 2020
Celia Brown