CRISC Certified in Risk and Information Systems ControlRisk Response and ReportingMedium
A pharmaceutical company is developing a new drug. The project involves significant regulatory compliance risks. The risk management team needs to ensure that all relevant regulations (e.g., FDA, EMA) are considered and that controls are designed to meet these requirements. Which type of control is MOST critical to implement to ensure proactive adherence to these external mandates throughout the drug development lifecycle?
- APreventive controls, embedded into processes to ensure compliance from the outset.
- BDetective controls, such as internal audits of regulatory submissions.
- CCorrective controls, used to address non-compliance issues after they occur.
- DCompensating controls, to offset weaknesses in existing regulatory adherence measures.
Show answer & explanationAnswer & explanation
Correct answer: A. Preventive controls, embedded into processes to ensure compliance from the outset.
For proactive adherence to external mandates throughout a complex lifecycle like drug development, preventive controls are most critical. They are designed to stop unwanted events (like non-compliance) from occurring in the first place by embedding compliance requirements directly into processes and procedures. Detective controls identify issues after they've happened, corrective controls fix them, and compensating controls address gaps, but none are as effective for proactive adherence as preventive controls.
Why the other options are wrong
- B. Detective controls identify non-compliance after it occurs, which is important but not proactive.
- C. Corrective controls fix issues post-event and are reactive, not proactive.
- D. Compensating controls address weaknesses but don't inherently ensure proactive, from-the-outset compliance with all mandates.
Preventive Controls
Controls designed to stop an undesirable event from occurring.
- Proactive in nature.
- Aims to prevent errors, omissions, or malicious acts.
- Often embedded into processes, procedures, and systems.
Memory trick: Prevention Protects Proactively.