Automated SOP creation to improve customer compliance with FDA Part 11 and speed the process of review and approval via electronic routing.
Simplified the Adverse Event reporting system for the Director of Medical Affairs to make it easier for staff to produce reports and look for trends and patterns in adverse events. This system was implemented in accordance with Part 11 and FDA regulation.
Prelude Computer Solutions, Inc.
Provided the Vice Presidents and Directors of Scientific Affairs with tools that enabled them to track expenditures and labor on all Scientific Affairs projects.
These new tools gave management a better means to anticipate project requirements, deploy resources, and track results.
Examples include: labor tracking, budget vs. expenditure tracking, submission planning, clinical supplies management, and internal audit tracking.
Introduced a novel way of staffing the help desk that reduced turnover by 80% and that more than doubled employee satisfaction with the help desk response.
Created the business case for automating the New Drug Application process uncovering immediate improvements that were made to business process. Developed a project plan and budget for the implementation of an Electronic Drug Submission system.
Reduced turn around for responding to FDA inquires from days to minutes by organizing and indexing documents that were used as the basis for submissions.
During one FDA audit the regulatory staff was able to respond to all inquires while the FDA was on-site. This vast improvement resulted in satisfactory response from FDA.
Automated the New Drug Application process, reducing time spent preparing documents and getting product to market shelves months faster.
Installed, trained, and validated Document Management and Publishing systems for Electronic Submissions.
Required compliance with FDA regulations such as 21 CFR Part 11, Guidance for Industry Documents, and validation.
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