For spreadsheets, which of the following 21 CFR Part 11 electronic records requirements is the most difficult to meet?

11.10(a) Validation to ensure accuracy, reliability, and consistent performance
17% (1 vote)
11.10(d) Limiting access to authorized individuals
0% (0 votes)
11.10(e) Secure, computer-generated, time-stamped audit trails
83% (5 votes)
11.10(k) Controls over system documentation
0% (0 votes)
Total votes: 6