TABLE OF CONTENTS In Chapter 6, the use of electronic signatures was discussed from a process perspective. The documented user requirements are tested in the PQ phase of the life cycle. Listed below are some of the test cases that could be considered for inclusion in the PQ test scripts covering electronic signatures. The pre-requisite for the testing is that appropriate users have been defined in the CDS together with electronic signature signing authorities allocated to them. In addition, samples have been analysed and there is a report available to sign.
Test cases are as follows (note that most are designed to fail rather than pass):
The appropriate tester and reviewer both sign in the correct order should be supported by the CDS together with documented evidence of the correctly signed report
Signature manifestations of both the tester and the reviewer meet 21 CFR 11 requirements
Reviewer attempting to sign as the tester should fail
Tester attempting to sign as the reviewer should also fail
The same person signing both as a tester and a reviewer should be rejected
Attempt by an unauthorised user to sign the report should be rejected by the system
A reviewer attempts to electronically sign the report before tester will be rejected
