The validation of automated or computerized systems should ensure that: Response:

Question

Options

• ASystems are capable of posting updates to social media automatically
• BSystems are resistant to any form of cyber-attack, even hypothetical future threats
• CCritical parameters are identified, controlled, and monitored
• DSystems require minimal to no maintenance over their operational life

• A
  5% (2)
• B
  3% (1)
• C
  82% (31)
• D
  11% (4)

Explanation

Validating automated or computerized systems in regulated industries (pharma, manufacturing, clinical settings) means demonstrating that a system consistently does what it is designed to do - which requires identifying critical parameters (e.g., temperature, pressure, data integrity fields), ensuring they are controlled within specifications, and monitored throughout operation. This is the foundation of frameworks like GAMP 5 and FDA 21 CFR Part 11.

Why the distractors are wrong:

• A is irrelevant - social media posting has no place in system validation standards.
• B is an impossible guarantee; validation does not promise resistance to all future, hypothetical threats - that's an unrealistic security standard.
• D contradicts reality; validated systems still require periodic revalidation, maintenance, and change control throughout their lifecycle.

Memory tip: Think of validation as "IQ/OQ/PQ" (Installation, Operational, Performance Qualification) - each phase revolves around identifying what's critical, controlling it, and proving it's monitored. If you remember that validation = control of critical parameters, option C will always stand out.

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