Conquering the Last Paper Mountain

The Impending Extinction of Paper Master Records

Product Code IDC09724
Publication Date January 2010
Publisher IDC
Product Type Report
Pages 4
ISBN Number not applicable

Conquering the Last Paper Mountain

The Impending Extinction of Paper Master Records

This IDC Health Insights Perspective highlights leading efforts to eliminate the creation of paper versions of the master documents created during drug development. Building on leading efforts by a consortium of major German life science companies, the need for paper master documents has been refuted, a fading practice further reinforced by the rapid transition to electronic submissions expected over the next few years. For those paper documents already in place, there is discussion as to whether there is sufficient value in conversion to electronic master documents or whether documents should remain in place until regulatory holding requirements expire. As the last bastion of massive quantities of paper, the elimination of paper master documents finalizes the shift away from paper and helps to advance effective pragmatic information management processes out of the 20thcentury.

This Perspective is based on independent IDC research, a QUMAS Webinar on the topic (see www.qumas.com/webinars/sounds-of-compliance-two.asp), and direct discussions with a leading industry manager implementing the change at a major multinational pharmaceutical company.

Contents

  • In This Perspective
    • Situation Overview
      • Regulated Document Holding Requirements
      • Changing the Status Quo
      • To Convert or Not to Convert
    • Essential Guidance
      • A Future Without Paper
  • Learn More
    • Related Research