Auditing Systems for 21 CFR Part 11-Validation of Software Programs – We have a GcP app on a server. When we need to install some additional utility apps and supporting app on that server such as Adobe Reader, Word and Firefox, do we need to qualify or validate these software programs?
You would need to do a supplemented validation under change control and see what is likely to be affected and do a regression analysis testing on the elements that are likely to be modified or affected because of this.
