Information Technology

Question 1

1. Which of the following are included in a Blood Establishment Computer System?
   a. hardware
   b. software
   c. user manuals
   d. all of the above

Answer 1

d. all of the above

Question 2

2. Which of the following ensures the environment in
   which the computer system operates is appropriate?
   a. IQ
   b. OQ
   c. PQ
   d. NQ

Answer 2

a. IQ

Question 3

3. True or false? Involvement of all stakeholders is critical
   to developing successful requirements.

Answer 3

True

Question 4

4. Testing of cases under stress conditions would be performed during which type of test?
   a. IQ
   b. OQ
   c. PQ
   d. NQ

Answer 4

b. OQ

Question 5

5. Which of the following regulations would BECS software vendors be required to meet?
   a. 21 CFR 211
   b. 21 CFR 610
   c. 21 CFR 820
   d. 21 CFR 809

Answer 5

c. 21 CFR 820

Question 6

6. True or false? Blood establishments do not need to be familiar with the quality system regulations for medical device manufacturers.

Answer 6

False