From the Experts Blog - Montrium

Articles from Montrium's Expert Professional Services team!

Receive Weekly Updates in your Inbox
 

SUBSCRIBE TO THE EXPERTS BLOG

Saas

The Truth About Software Validation in the Life Sciences

As cloud computing becomes increasingly popular with companies looking to cut IT costs and increase efficiency, it is not surprising that cloud services providers seem to offer Software as a Service (SaaS) solutions to meet just about every business need.

Cloud vendors are specifically targeting life science companies by developing SaaS products that meet industry-specific compliance requirements. These specialized products can manage a range of regulated activities, such as the application of electronic signatures and the management of pharmacovigilance cases.

The sales pitch is enticing - avoid the costs (and headaches) that come with maintaining internal IT infrastructure, while utilizing software that allows your organization to operate in accordance with applicable regulations. But is this promise too good to be true? Let’s take a closer look at some important considerations that should be taken into account when validating a SaaS product to manage GxP content and achieve compliance in the cloud. 

The Microsoft Azure Cloud
Where do Annex 11 and Part 11 intersect?