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Accelerator Tool for Life Sciences Authority Approvals

By April 9, 2024November 13th, 2024Uncategorized

CASE STUDY:

Accelerator Tool for Life Sciences Authority Approvals

Medical Device Manufacturer realizes ROI faster and improves compliance through Documentum Accelerator Tool

80

Reduction in Processing Time

0

Improved Compliance and Avoided Fines

Business Challenge

  • Surgical Eye Health products provider with locations and departments globally ​
  • Assembling of life sciences documents for a single product were on average 20,000 pages and spread across global departments​
  • Product materials required assembly in a specific order and with defined formats​
  • Published product document approvals required compliance with specific file format, ordering and labeling criteria from the Life Sciences Authority

Solution

  • Developed add-on accelerator tool automating the assembly process of life science product documents for approval by the Life Sciences Authority​
  • Enabled assembly and publishing of materials from different departments globally into a single PDF document, including automation of page numbering, bookmarks, links and table of contents for entire manual or technical file​
  • Created streamlined approval process for submitting assembled product documents to Life Sciences Authority portal site that meet predefined requirements​
  • Changes to Life Sciences Authority predefined criteria are now automatically updated in the accelerator tool

Benefits & ROI

  • Reduced processing, publishing and approval time from several weeks to one day​
  • Reduced errors through automated assembly and publishing of life sciences documents and elimination of manual processing​
  • Improved compliance and avoided fines by ensuring current Life Sciences Authority requirements are being met​
  • Ability to bring products to market faster due to quicker processing and approval of life sciences product documents
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