The clinical auditor's perspective : to err is human
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Accelerated by technology, our pharmaceutical, biotechnology and medical device industries are changing at the speed of light. With these technological changes, some management personnel seem to believe that if processes are controlled by technology, lesser qualified personnel can fill many roles in the clinical trials. In some companies, this leads to a dangerous disconnect where technology improves, but the quality of the personnel diminishes and data integrity is therefore put at risk. Compounding this trend is a misplaced trust in robots and computers, and insufficient numbers of personnel ...