Blog Category: Purchased Systems


validate cloud system, saas system, fda expectations

8 Regulatory Expectations for Purchased Systems (whether installed in-house or SaaS)

By Deb Bartel,

If you have purchased or are planning to purchase a computer system for use in regulated activities, here are some key points to keep in mind. As the regulated company, your responsibilities differ from those of your vendor. There are examples from multiple regulatory documents regarding cloud and SaaS computer systems. 1. You are ultimately responsible (not the vendor) As  … Read more