Infrastructure Qualification in Information Technology is a hot topic these days. And for good reason. Yes, validation is for intended use. And yes, validation applies to the application. However, the application server, the operating system, the database, etc. all still need to be well documented and controlled. We need to know that the functionality the infrastructure provides to the application complies with the needs of the application (validation) and with Part 11 (security, data integrity, etc.). We can do this on a case-by-case basis when we validate each application or we can qualify our infrastructure across a range of parameters, thereby preparing us to validate our application.
That will be the topic this month. I will explore several considerations regarding Infrastructure Qualification, including why you might considering taking this approach, how to go about it, and what some of the challenges may be.
So check back for more postings and be sure and check out the webinar on October 26.