MAY 2022LIFE SCIENCES REVIEW8IN MY OPINIONor global life science companies, the challenge of maintaining effective oversight and control over dozens of activities taking place simultaneously across multiple jurisdictions can be daunting--especially when such companies rely on paper processes. As anyone who has been audited or investigated knows painfully well, if you can't prove oversight and control through documentation, then such oversight and control didn't happen.This underscores the vital importance of documentation and the weakness of paper processes. When it comes time for non-automated compliance programs to demonstrate effectiveness, documentation is often missing because compliance officers across multiple jurisdictions are saving their documentation onto different computer systems or servers, forgetting to scan and upload required documentation, and/or are unable to demonstrate version control. This is where technology can save the day.At Amicus, we use a single, global, compliance approval system to review and approve activities taking place around the world. So, regardless of whether the activity involves the French business team hiring a physician in France, the Japanese business team conducting an advisory board in Japan, or the US business team sponsoring medical education in the US, all requests for approval are submitted using the exact same online compliance approval system, which we've called the Amicus Compliance Engine (ACE). ACE is powered by an out-of-the-box, yet highly configurable, compliance automation software provided by Lextegrity, a leading software firm started by former in-house life sciences compliance and audit professionals.When new By Patrik Florencio, SVP and Chief Compliance & Risk Officer, Amicus Therapeutics and Michael Schneider, Executive Director, Global ERM and Compliance Auditing, Amicus TherapeuticsHOW TECHNOLOGY ENHANCESTHE EFFECTIVENESS OF COMPLIANCE PROGRAMSF
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