ExpertPMP · Question 06 · Task 1: Plan and manage project compliance
A pharmaceutical project must comply with FDA regulations. During a routine audit preparation, the project manager discovers that a team member unknowingly used a non-compliant data storage method for clinical trial information over the past month. The data integrity appears intact, but the storage method violates regulatory requirements. What should the project manager do FIRST?
A pharmaceutical project must comply with FDA regulations. During a routine audit preparation, the project manager discovers that a team member unknowingly used a non-compliant data storage method for clinical trial information over the past month. The data integrity appears intact, but the storage method violates regulatory requirements. What should the project manager do FIRST?
Answer options:
Document the issue in the risk register and implement additional training for all team members
Immediately halt the affected work and assess the full compliance impact with the regulatory team
Report the team member to HR for not following established procedures
Continue the work while implementing the correct storage method going forward
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