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Publishing Automation – Reduce Manual efforts and cost

Publishing is Pain. Doesn’t matter what tools you use. Our solution automates document publishing. Whether your source files are in WORD DOC or PDF, get submission ready files in SECONDS. With 350+ rules library, you pick and create your custom plans with flexibility of applying what/when to your documents on the fly. You are in control as all this is done using a simpler user interface that’s cloud-based (or can be run as batch connecting to your EDMS or PLM/ERP systems).

ROI / Savings: 70% and above compared to your current costs. Guaranteed!

Functionality

  1. Publishing Rules: Standard Out-of-box rules for FDA, EU, and other regions +you can use any custom publishing rules from our vast library on DOC or PDF (Tables, Font management, TOC, Bookmarks, Headers/Footers, Hyperlinks, File-level general options, and more)
  2. File Sources: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, BOX, and other 3rd party Sources.
  3. Download: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, RIM, and several 3rd party Sources. The use of regulatory analytics can help regulatory teams to make more informed and data-driven decisions, leading to more effective and efficient regulatory policies and compliance.
  4. Access: Cloud (hosted on Private Cloud in USA/Germany)

Post – Publishing QC

Validate Custom Dossiers/Submissions with customized Dossier checks covering dossier elements, titles, and data/content level.

  • Automate validation based on your checklists

  • Create custom validation plans at dossier level and different plans for the documents within those dossiers (Standard and Custom dossiers)

  • Inter-Document hyperlinks check and automate updates

  • Auto-update of File Names, Elements, Leaf titles matching to your internal standards

  • Selectively test validation paths of the defined checks and parameters

Related Tools & Solutions

Submission Management

Regulatory Document Management

Regulatory Information Management

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