Enabling Digital Transformation in Controlled Environment in Menarini

Transcription

1 Enabling Digital Transformation in Controlled Environment in Menarini Eugenio Capasso Corporate Director for Organization Development and ICT Copyright 2016 Dell.. All rights reserved. 1

2 Agenda Menarini Group Business Issues Solution Benefits 2

3 Menarini Group 3

4 Worldwide Presence Menarini is present with its affiliates, distributors and franchises in more than 100 countries worldwide. 4

5 Turnover 5

6 Employees 6

7 International and Business Components 7

8 Manufacturing Sites 8

9 Research & Development Centers 9

10 Agenda Menarini Group Business Issues Solution Benefits 10

11 The current Landscape Growing by Acquisitions has implied: Different Information Systems Different standards in writing and approving procedures Security Risk : important information exposed to potentially inappropriate people. Loss of Information: Critical documents stored, often exclusively, on laptop computers Lack of Audit Trail 11

12 Paper Based Flows Managing the majority of Procedures still on manual paper flows, implying: No guarantee that the user is working on the current and right version (multiple copies available) Hard to monitor Training and fully Understanding of the procedures Very labour intensive and expensive, given the long record retention requirements for regulated content in the life sciences. 12

13 Computer System Validation Living in a Controlled Environment Computer Systems are subject to rigorous inspections from Authorities Documented evidence that the solution has been properly implemented and tested Compliance to GxP implies detailed System Functionalities (i.e.: Electronic Signature based on CFR21.11) 13

14 Agenda Menarini Group Business Issues Solution Benefits 14

15 The Selection Process We did a detailed process and we selected EMC/Life Sciences solution for the following main reasons: Documentum largely adopted in the Life Sciences Industry as DMS Solution cover full DMS lifecycle from Drug discovery and investigation to Manufacturing reducing Total Cost of Ownership Solution is based on common common security infrastructure and preconfigured standardized workflow Liked by our Key Users 15

16 Which Processes Pharmacovigilance Dossier (PSMF) Summary of Product Characteristics Quality and Manufacturing SOP s Pharmacovigilance Procedures Clinical and Preclinical Procedures 16

17 Which Modules LS Research &Development Module LS Quality & Manufacturing Module Unified Solution Layer to guarantee Shared configurations Document Inventory Document Lifecycles Document Workflows Document Properties User roles 17

18 LS Q&M & R&D: figures and numbers Q&M 2015 Q4: Startup of the initiative with a medium site (Barcelona) > 250 users and > documents imported By the end of 2017: Rollout to the rest of Manufacturing sites for users Additional Q&M streams under design phase 2016 Q4: Pharmacovigilance Procedures 2017 Q1: Clinical and NonClinical Procedures R&D 2016 Q1 SmPC (Regulatory domain) 2016 Q3 PSMF dossier (Safety domain) 18

19 Project Approach The advantage of having a preconfigure solution allowed us to «force» the adoption of a «zero change» approach Questions to the Business Users have been: «if the major Life Sciences Company are working in this way, why don t you?» The approach has dramatically improved implementation Time & Costs 19

20 WHAT S NEXT: Roadmap We are implementing the Solution by gradually rolling out it on our Country Locations At the same time, we are taking advantage from the single platform to evaluate expanding the scope from a Process standpoint Research & Development Trials Master Files Regulatory Dossier Document Distribution to field forces 20

21 Project Organization Implementing a Document Management System in a Controlled environment is not only an IT Project The Project Team should also include the following key roles: Quality Assurance: to meet GxP processes & functionalities Organization: to help implementing standard & new processes globally CSV experts: to establish the proper methods in order to achieve the System Validation and guarantee Compliance 21

22 The Implementation Partner To help us implementing the Solution globally in the safest way, we have selected EMC Professional Services In this way, we are ensuring the best expertise on the tool and we have a single partner for software and project topics 22

23 Agenda Menarini Group Business Issues Solution Benefits 23

24 Benefits Central repository for all your important documents Anytime, anywhere access Security and access control Search and retrieval (full text, metadata..) Version control Indexing and classification (better organization) Audit trails Compliance Process Efficiency 24

25 LET US KNOW WHAT YOU THOUGHT Take the Session Survey 1. Open the schedule with the Momentum App 2. Go to the session you attended 3. Open Session Survey 4. Answer the 4 questions and submit. Thank you! 25

26 Thanks 26