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Per FDA Guidance, you "should consider auditing the vendor’s _________ used in construction of OTS (off the shelf) software”
Design and Development methodologies
25% (3 votes)
Quality Assurance and Control practices
25% (3 votes)
Risk Assessment and Mitigation methods
0% (0 votes)
Validation and Verification procedures
50% (6 votes)
Total votes:
12
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Poll
Which of the following can provide evidence of compliance in a software quality audit?:
Company procedures (e.g. SOPs)
Records and documentation
Observation of work being performed
All of the Above
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