Automating FDA for Business Efficiency
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Automating FDA for Business Efficiency

Walter Harris, Deputy Commissioner Operations/COO, U.S Food and Drug Administration
SharePoint Initiatives to Streamline Business FDA recently implemented SharePoint based on the following major requirements:
• Enterprise solution;
• Federal records management requirements;
• Ease of migration from 1,600 sites;
• True collaboration, not just network file sharing; and
• 508 compliance that ensures accessibility to staff with disabilities and use of seamless information and data to do their jobs
"Having a team of both IT personnel and business representatives during the implementation allows for engaged and collaborative team members" 
FDA has utilized SharePoint in initiatives to improve efficiencies and productivity gains that include:
Streamlining of business and approval processes, reducing process times while providing a detailed accounting of the  workflow. Reduction in time to transform program-specific applications  into enterprise capabilities, requiring minimal development time and an overall reduction in future development expenses. Improved real time communications across the Agency; standardized mechanism for communications to our customers while accounting for customer view preferences.
Maximize Utility of Sharepoint through Experienced Implementers
Focusing on lessons learned from experienced implementers and knowledge transfer. The engagement with other (federal)  organizations that have successfully implemented and managed SharePoint implementations similar in size and complexity to our requirements, to seek guidance and leverage their lessons learned.
• It has also been imperative to provide a variety of training modalities for staff e.g. online & in person. This allows for  staff to choose environment they best learn.
• Having a team of both IT personnel and business representatives during the implementation allows for engaged and  collaborative team members. This can be  accomplished by:
• The establishment of a Governance Board from the beginning to ensure requirements and processes are defined and adhered to.
• Communication must occur early and often by leveraging every available communication mechanism in order to obtain buy in, provide transparency and increase solution usage.
• Minimizing customization of the solution, when possible, as it reduces the complexity of maintenance and upgrade  activities.
• Identifying initial “test” group for rollout (e.g., IT organization, program early adopters) to work out any technical  issues.
• Closely monitor and act upon feedback and service tickets.
SharePoint for Real-Time Replication of Data
We have used business automation functions at FDA to improve the way we conduct day-to-day business, such as: Processing of internal and external requests for FDA speakers to participate in engagements. We leverage rules-based logic  during the approval process and integrate with external data sources to access information to assist in the decision workflow. Processing of Conference and Travel Requests, providing the ability for approval or rejection of requests in accordance with federal regulations and guidelines. Drug Shortages: FDA’s public-facing site used to deliver timely drug shortage information leverages the SharePoint tool as the back-end data repository, providing real-time replication of data  to FDA’s proprietary AccessData system.
In final testing phases is FDA’s IT maintenance and outage alerts process, which  centralizes IT service announcements and provides customers a customized way to view data they are particularly interested in. It will also provide real time information on:
• Current outages and emergency notifications,
• Upcoming maintenance activities, and
• Security threats.

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