Managing Automation - November 2008 - (Page 40) [NOVEMBER 2008] Transformation Integration TechWatch Industries [ INDUSTRIES ] WAVES PAPER The FDA’s move to mandate electronic filing of new product information submissions is setting the stage for a new wave of changes for pharmaceutical manufacturers. BY MARTY WEIL Ending the Endless of f a semi-trailer truck filled with thousands of documents consistently showed up at your office for review, no one would question your sanity if you tried to put a stop to the practice. The U.S. Food and Drug Administration, the powerful government agency that controls the pharmaceutical industry, has decided to do just that by ending the practice of paper-based regulatory submission, which, in recent times, has generated a continuous tsunami of paper. To do so, the FDA has mandated the electronic Common Technical Documents (eCTD) specification as the standard format for the submission of all new drug applications and sup- plements. The agency’s decision, which went into effect at the beginning of this year, has increased pressure on life sciences and drug companies to comply by automating and streamlining their operations. U.S. drug manufacturers are scrambling to modify their document publishing and submission processes for compiling new drug submission data — originally designed for paper — so that they can submit product regulatory filings electronically to the FDA. eCTD submissions simplify the FDA’s evaluation process while taking into consideration the creation, review, lifecycle management, and archival of new drug submission data. “The new electronic standards for the ex- ma November 40 2008 Illustration: Simon Oxley
Table of Contents Feed for the Digital Edition of Managing Automation - November 2008 Managing Automation - November 2008 Contents Take 1 At One-Year Mark, Wonderware President Focuses on Empowering Plant Operators Oracle Demos Fusio Apps, Reveals Delays Baan Founder Says BPM Will Replace ERP Emerson Talks Wireless at Annual User Group Event Merger Complete, Intercim Focuses on Collaboration Notes Cover Story: The New Supply Chain Reality Special Report: Keep Out Integration: The On-Demand Interchange Industries: Ending the Endless Waves of Paper Product Scan Advertiser Index Next Managing Automation - November 2008 Managing Automation - November 2008 - Managing Automation - November 2008 (Page Cover1) Managing Automation - November 2008 - Managing Automation - November 2008 (Page Cover2) Managing Automation - November 2008 - Managing Automation - November 2008 (Page 3) Managing Automation - November 2008 - Contents (Page 4) Managing Automation - November 2008 - Contents (Page 5) Managing Automation - November 2008 - Contents (Page 6) Managing Automation - November 2008 - Contents (Page 7) Managing Automation - November 2008 - Take 1 (Page 8) Managing Automation - November 2008 - Take 1 (Page 9) Managing Automation - November 2008 - At One-Year Mark, Wonderware President Focuses on Empowering Plant Operators (Page 10) Managing Automation - November 2008 - Oracle Demos Fusio Apps, Reveals Delays (Page 11) Managing Automation - November 2008 - Baan Founder Says BPM Will Replace ERP (Page 12) Managing Automation - November 2008 - Baan Founder Says BPM Will Replace ERP (Page 13) Managing Automation - November 2008 - Baan Founder Says BPM Will Replace ERP (Page 14) Managing Automation - November 2008 - Emerson Talks Wireless at Annual User Group Event (Page 15) Managing Automation - November 2008 - Emerson Talks Wireless at Annual User Group Event (Page 16) Managing Automation - November 2008 - Merger Complete, Intercim Focuses on Collaboration (Page 17) Managing Automation - November 2008 - Notes (Page 18) Managing Automation - November 2008 - Notes (Page 19) Managing Automation - November 2008 - Cover Story: The New Supply Chain Reality (Page 20) Managing Automation - November 2008 - Cover Story: The New Supply Chain Reality (Page 21) Managing Automation - November 2008 - Cover Story: The New Supply Chain Reality (Page 22) Managing Automation - November 2008 - Cover Story: The New Supply Chain Reality (Page 23) Managing Automation - November 2008 - Cover Story: The New Supply Chain Reality (Page 24) Managing Automation - November 2008 - Cover Story: The New Supply Chain Reality (Page 25) Managing Automation - November 2008 - Special Report: Keep Out (Page 26) Managing Automation - November 2008 - Special Report: Keep Out (Page 27) Managing Automation - November 2008 - Special Report: Keep Out (Page 28) Managing Automation - November 2008 - Special Report: Keep Out (Page 29) Managing Automation - November 2008 - Special Report: Keep Out (Page 30) Managing Automation - November 2008 - Special Report: Keep Out (Page 31) Managing Automation - November 2008 - Special Report: Keep Out (Page 32) Managing Automation - November 2008 - Special Report: Keep Out (Page 33) Managing Automation - November 2008 - Integration: The On-Demand Interchange (Page 34) Managing Automation - November 2008 - Integration: The On-Demand Interchange (Page 35) Managing Automation - November 2008 - Integration: The On-Demand Interchange (Page 36) Managing Automation - November 2008 - Integration: The On-Demand Interchange (Page 37) Managing Automation - November 2008 - Integration: The On-Demand Interchange (Page 38) Managing Automation - November 2008 - Integration: The On-Demand Interchange (Page 39) Managing Automation - November 2008 - Industries: Ending the Endless Waves of Paper (Page 40) Managing Automation - November 2008 - Industries: Ending the Endless Waves of Paper (Page 41) Managing Automation - November 2008 - Industries: Ending the Endless Waves of Paper (Page 42) Managing Automation - November 2008 - Industries: Ending the Endless Waves of Paper (Page 43) Managing Automation - November 2008 - Industries: Ending the Endless Waves of Paper (Page 44) Managing Automation - November 2008 - Industries: Ending the Endless Waves of Paper (Page 45) Managing Automation - November 2008 - Product Scan (Page 46) Managing Automation - November 2008 - Product Scan (Page 47) Managing Automation - November 2008 - Product Scan (Page 48) Managing Automation - November 2008 - Product Scan (Page 49) Managing Automation - November 2008 - Product Scan (Page 50) Managing Automation - November 2008 - Product Scan (Page 51) Managing Automation - November 2008 - Product Scan (Page 52) Managing Automation - November 2008 - Product Scan (Page 53) Managing Automation - November 2008 - Product Scan (Page 54) Managing Automation - November 2008 - Product Scan (Page 55) Managing Automation - November 2008 - Product Scan (Page 56) Managing Automation - November 2008 - Product Scan (Page 57) Managing Automation - November 2008 - Product Scan (Page 58) Managing Automation - November 2008 - Product Scan (Page 59) Managing Automation - November 2008 - Advertiser Index (Page 60) Managing Automation - November 2008 - Advertiser Index (Page 61) Managing Automation - November 2008 - Next (Page 62) Managing Automation - November 2008 - Next (Page Cover3) Managing Automation - November 2008 - Next (Page Cover4)
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