No 1: Difference between Validated and NonValidated:
(1) Validated System------Closed System
(2) Non Validated------Open System
No 2: Which rulers does validated system contain?
(1) Every user has to be unique
(2) Every signature should be unique identified
(3) Every record has two signature (autor and reviewer)
No 3: How to manage validated system?
(1) Administratered
(2) Audit Trail
(3) Person are trained
(4) Individuals are responsible
(5) Data cann’t be manipulated
(6) Reproducible
No 4: Which method does Validated system use?
(1) Include screen shot in every resulting step
(2) Convert finalized test case to PDF
(3) Print out
(4) Which way execute Test Case
No 5: How to create the protection for PDF?
(1) Install Security Add-in
(2) File--->Document--->Security---->Certificate Security---->Save these settings as policy
(3) After creatig protection, you can click “sign”---->”autor”/”reviewer”, and then you can change or write review comments
No 6: Where identifies “Validated/Non Validated”?
(1) 21 CFR (part 11), CFR is the abbreviation of “Code of Federal Regulation”, it is created in 1999 by Cliton
(2) FDA------Food & Drug Administrator
(3) 21 CFR (part 11) is about electronic signature & Elec Records
