RA Manager: eCTD Publishing: The Case for Outsourcing

Posted 01 January 2008 | By

Until quite recently, regulatory submissions were compiled manually, usually by relatively low-skilled administrative staff working under the supervision of regulatory professionals. Paper copies of reports and documents were compiled into volumes, page-numbered, indexed, photocopied, tabbed and bound for submission. The shift from paper submissions to electronic submissions in recent years has been accompanied by corresponding changes in business processes. Electronic submission publishing requires a greater level of skill and experience than paper compilation, and the switch to electronic submissions has resulted in the emergence of a new type of specialist within regulatory affairs-the "submission publisher." Many companies have invested in sophisticated regulatory document management and publishing systems, which provide an electronic repository for storage and control of regulatory documentation, together with tools for submission assembly and publishing. Electronic submissions are categorized as "electronic records;" thus, 21 CFR part 11 is applicable to the systems used for submission publishing.1


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