Q: How should we go about validating data warehouses and business intelligence systems?
I understand that any regulated source systems would, of course, need to be validated individually. But how do you validate the data that has been extracted, transformed and loaded into data warehouses?
Also, how would you handle the front-end business intelligence software? In our system, anyone can create a report using regulated data. Would you consider these reports similar to Excel spreadsheets — where you only validate the regulated reports built with the software?
A: Data warehouses are places to store data that you may need in the future. If the data is already electronic and is being transferred, you must assure that the transfer process is validated and that the data going into the data warehouse is put in the right places to be retrieved.
Depending on the criticality of the data, you should do a sampling plan of the data in the current system, retrieve the same data from the data warehouse, and then assure the information is the same.
“The sampling protocol you use must be statistically valid for the amount and criticality of the data.”
If the data is being put in manually, you should compare a sample of the hard copies with the data in the warehouse. The sampling protocol you use must be statistically valid for the amount and criticality of the data.
And yes — the front-end business intelligence software is validated just like you would validate an Excel report. You are validating your use of the business intelligence software against your intended use.
Answered by Janis Olson, Vice President of Regulatory and Quality Services for EduQuest. Jan served as an expert field investigator and regional director of information management resources during her 22-year career at FDA. She also is the co-instructor of EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance training class. The class, originally developed at FDA’s request to train Agency field personnel, is now in its 23rd year of training industry professionals worldwide.