Certified Data Management Professional CDMP Associate · Free Practice Question Medium
Question 5
A pharmaceutical company needs to implement a content management strategy for its research documents. Which approach would best address their regulatory compliance requirements?
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A
Implement a single document repository with basic version control
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B
Use cloud storage with encryption for all research documents
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C
Deploy a comprehensive ECM system with lifecycle management, audit trails, and controlled workflows
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D
Develop custom applications for each department to manage their own documents
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E
Focus on document digitization with minimal metadata
Reveal correct answer
Correct answer: C
Explanation
The pharmaceutical industry faces strict regulatory requirements (such as FDA 21 CFR Part 11, GxP, etc.) for document management. A comprehensive Enterprise Content Management system provides the necessary controls through defined document lifecycles (from creation through approval, use, and eventual disposition), audit trails to track all document interactions, and controlled workflows that enforce proper review and approval processes. This approach ensures that research documents remain compliant with regulatory requirements while supporting efficient business processes.
Discussion
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