Transitioning to Electronic Publishing
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0092-8615/2000 Copyright 0 2000 Drug Information Association Inc.
TRANSITIONING TO ELECTRONIC PUBLISHING MELISSAA. MAYNARD Associate Director, Regulatory Information Systems, Regulatory & Technical Services, Quintiles, Inc., Research Triangle Park, North Carolina
The following article discusses issues associated with transitioning to publishing regulatory submissions electronically. Main points include background on deciding to implement an electronic publishing system, criteria for system selection, resultant installatiodimplementation, and reflection on ke.y consideration points that aid in creating a successful program. Key Words: Electronic; Submissions; Publishing; Implementation; Regulatory
INTRODUCTION DUE TO VARIOUS influences present in the pharmaceutical industry and recent Food and Drug Administration (FDA) guidance regarding acceptance of electronic submissions by 2002, in 1998 Quintiles made the decision to explore possible solutions for electronic submission publishing. Historically, creating a regulatory submission has been a painstaking and time-consuming process involving months of working at double-shift capacity, with submissions consisting of many thousands of individual pieces of paper, handtyping large tables of contents, typing and retyping reports, hand-paginating, photocopying, inserting into binders, packing in boxes, and eventually loading into a truck to be driven to the FDA. We needed a system that would provide the ability to create electronic submissions reliably, cost-effectively, and with greater ease of use based on file system repository and potentially a formal document manage-
ment system. Criteria for selection included a product that was globally available, capable of compiling submissions according to FDA guidance, Drug Application Methodology with Optical Storage compliant, and provided global software support and continued ongoing software development (ie, manufacturer changedimproved product with input from customers and as regulatory agency guidance evolved). Consideration of various electronic publishing systems led to the launch of a pilot CoreDossier program in May 1998. In November 1998 we proceeded with installation and implementation of the CoreDossier software in a production environment and moved forward with computer system validation efforts that concluded successfully in early January 1999. Our first submission using CoreDossier was completed and submitted to the FDA on January 29, 1999. Our final decision resulted in the installatiodimplementation of a global electronic publishing system (CoreDossier 3.1.2) which consists of three United States sites and one in Europe.
Reprint address: Melissa A. Maynard, Associate Director, Regulatory Information Systems, Regulatory & Technical Services, Quintiles, Inc., PO Box 13979, Research Triangle Park, NC 27709-3979.
EXPERIENCE Reflecting on the process of facilitating a smooth transition to electronic submissions,
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