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1 © Copyright 2016 Dell . All rights reserved. 1 © Copyright 2016 Dell. All rights reserved.

Enabling Digital Transformation in Controlled Environment in Menarini

Eugenio Capasso Corporate Director for Organization Development and ICT

2 © Copyright 2016 Dell . All rights reserved.

Agenda Menarini Group

Business Issues

Solution

Benefits


Menarini Group


Worldwide Presence

Menarini is present with its affiliates, distributors and franchises

in more than 100 countries worldwide.


Turnover


Employees


International and Business Components


Manufacturing Sites


Research & Development Centers



Business Issues

Solution

Benefits


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


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.


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)



Business Issues

Solution

Benefits


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


Which Processes

Pharmacovigilance Dossier (PSMF)

Summary of Product Characteristics

Quality and Manufacturing SOP’s

Pharmacovigilance Procedures

Clinical and Preclinical Procedures


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

Which Modules


LS Q&M & R&D: figures and numbers Q&M

– 2015 Q4: Startup of the initiative with a medium site (Barcelona) > 250 users and > 4.000 documents imported

– By the end of 2017: Rollout to the rest of Manufacturing sites for 1.500 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)


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


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


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


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



Business Issues

Solution

Benefits


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


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!

© Copyright 2016 Dell . All rights reserved.


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