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AMTSOL Basic Life Science - Computerised System Validation Training

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1. Which of the following is considered a type of automation system in the context of computerized systems?
Information systems Standalone DCS or SCADA systems Pre-configured control systems with no changeability Data systems
2. Which of the following is NOT a primary reason for the necessity of validation in regulated industries?
Ensuring compliance with regulations Improving operational efficiency Mitigating risks associated with processes and systems Enhancing customer confidence
3. Which type of validation strategy involves validating a process or system in real-time as it operates, using the data produced during its actual use?
Prospective Validation Retrospective Validation Concurrent Validation Revalidation
4. What is the primary purpose of 21 CFR Part 11 in the context of Computerized System Validation (CSV)?
Setting forth specific requirements for electronic records and electronic signatures. Defining the scope of FDA regulations for pharmaceuticals. Regulating the use of paper records in FDA-regulated industries. Establishing criteria for the physical security of computerized systems.
5. Which key principle of data integrity ensures that data remains consistent across different records and systems?
Accuracy Completeness Reliability Consistency