S12

Computer Applications

Hardware, networking, 21 CFR Part 11, ALCOA+, SUGAM, e-governance

5.5%
of the paper
≈ 6 marks
#7
by weightage
of 13 topics
106
questions
with explanations
0
cite a provision
Act, Rule or Schedule

Weightage is measured from previous Drug Inspector papers, not estimated. Question counts are read from the live bank when this page is built.

Subtopics in this bank

DatabasesHardware & OS basicsLIMS compliance with regulatory expectationsLaboratory IT systemsNetworking & internetPharmaceutical databasesProgramming in drug developmentSecurity & malwareSpreadsheet validation and batch release governanceStatistical analysis and root cause investigationWord processing

Sample questions, with the reasoning

Every question in the bank is explained like this — including why each wrong option is wrong.

"Spell check" is under which menu in Microsoft Word?

  • A)Edit
  • B)View
  • C)Tool
  • D)Format

Why C is correct

In the classic (pre-ribbon) MS Word menu structure, "Spelling and Grammar" (spell check) is located under the Tools menu.

AI fact-checked

21 CFR Part 11 requires that electronic records be retained in a manner that ensures data integrity. Which feature is NOT required by this regulation?

  • A)Digital signatures for authentication
  • B)Access controls and user authentication
  • C)Audit trails for all data modifications
  • D)Automatic deletion of records after 6 months

Why D is correct

21 CFR Part 11 requires retention of electronic records for specified periods (usually 2+ years); automatic deletion contradicts compliance. The regulation mandates digital signatures, audit trails, access controls, and time-stamping.

AI fact-checked

A batch record system implements version control. Which benefit does this provide?

  • A)Ability to recall and audit previous versions of records
  • B)Automatic deletion of old records
  • C)Prevention of all user errors
  • D)Encryption of all database files

Why A is correct

Version control maintains a history of record changes, allowing auditors to review original and modified versions, proving record integrity.

AI fact-checked

Practise S12 with real marking

106 questions · −1/3 negative marking · explanations after every answer. No sign-up needed to try.

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