Copyright © 2017 QuintilesIMS. All rights reserved.

How Your Document Management System Can Help You Align with eCTD 7th PharmaDoc Users Conference May 26, 2017

1

Introduction

Kathie Clark, Product Management Kathie Clark is responsible for the development of the Wingspan eREG and eTMF, as well as other Wingspan products focused on meeting challenges of companies in the life sciences. She has over 20 years of experience as an information technology professional in the life sciences industry and has worked with over 60 clients from in the US, Europe, Japan, and Israel. She frequently publishes white papers, journal articles, and blog posts.

© 2017 QuintilesIMS

2

The Wingspan Platform

Common Platform: • User Interface elements / Look

and Feel • Navigation • Document Authoring • Review & Approval Workflows • Export • PDF Generation • Administration

©Wingspan Technology 2017 - Confidential

3

• Streamlined solution for managing documents included in regulatory submissions and related documents • Focus on

–Insight into readiness of documents needed for upcoming submissions –Streamlined authoring, review and approval –Support for submission assembly and publishing –Integrations with other document and data sources

• Key Features –Authoring from template –Placeholder documents to aid in submission planning –Review, approval, eSignature workflows

Wingspan eREG

Result: Readiness for eCTD Mandate, whether publishing in-house or with a partner

4

• EDM Reference Model • Expanded to cover

major markets not in Reference Model (Japan, Canada, Switzerland, Australia, South Africa, Singapore, Saudi Arabia) • Pre-configured for

security, workflow, lifecycle, etc.

eREG Out of the Box Configuration

©Wingspan Technology 2017 - Confidential

5

EDMS Support of CTD/eCTD: Mapping to CTD Section

6

CTD Navigation for Publishers

7

• The ICH Granularity Annex dictates which documents must be submitted in each module > For eCTD, this means which physical files

(generally PDF) > EDMS should not allow you to create

documents that cannot be submitted

EDMS Support of CTD/eCTD: Granularity

NO NO NO YES NO

8

EDMS Support of CTD/eCTD: Producing Compliant PDFs

10

• eCTD Structure –Supports regional Module 1 and other regional documents as well as ICH

Module 2-5 –Tags documents with CTD section, file tag (if appropriate) –Applies metadata needed for dossier (drug substance, manufacturer,

excipient, study number and type, etc.) • Granularity

–Only allows creation of documents at allowed levels of granularity • PDF renditions

–Compatible with ICH, FDA, EMA, Health Canada, Swissmedic

Wingspan eREG Support of CTD/eCTD

©Wingspan Technology 2017 - Confidential

11 11

Thank You!

Kathie Clark Wingspan, a QuintilesIMS Company Please feel free to contact me through email, LinkedIn, or my ISID partners kclark@wingspan.com https://www.linkedin.com/in/kathieclark/ http://www.wingspan.com/ereg/