enabling digital transformation in controlled environment ... · enabling digital transformation in...
TRANSCRIPT
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
3 © Copyright 2016 Dell . All rights reserved.
Menarini Group
4 © Copyright 2016 Dell . All rights reserved.
Worldwide Presence
Menarini is present with its affiliates, distributors and franchises
in more than 100 countries worldwide.
5 © Copyright 2016 Dell . All rights reserved.
Turnover
6 © Copyright 2016 Dell . All rights reserved.
Employees
7 © Copyright 2016 Dell . All rights reserved.
International and Business Components
8 © Copyright 2016 Dell . All rights reserved.
Manufacturing Sites
9 © Copyright 2016 Dell . All rights reserved.
Research & Development Centers
10 © Copyright 2016 Dell . All rights reserved.
Agenda Menarini Group
Business Issues
Solution
Benefits
11 © Copyright 2016 Dell . All rights reserved.
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
12 © Copyright 2016 Dell . All rights reserved.
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.
13 © Copyright 2016 Dell . All rights reserved.
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)
14 © Copyright 2016 Dell . All rights reserved.
Agenda Menarini Group
Business Issues
Solution
Benefits
15 © Copyright 2016 Dell . All rights reserved.
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
16 © Copyright 2016 Dell . All rights reserved.
Which Processes
Pharmacovigilance Dossier (PSMF)
Summary of Product Characteristics
Quality and Manufacturing SOP’s
Pharmacovigilance Procedures
Clinical and Preclinical Procedures
17 © Copyright 2016 Dell . All rights reserved.
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
18 © Copyright 2016 Dell . All rights reserved.
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)
19 © Copyright 2016 Dell . All rights reserved.
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
20 © Copyright 2016 Dell . All rights reserved.
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
21 © Copyright 2016 Dell . All rights reserved.
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
22 © Copyright 2016 Dell . All rights reserved.
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
23 © Copyright 2016 Dell . All rights reserved.
Agenda Menarini Group
Business Issues
Solution
Benefits
24 © Copyright 2016 Dell . All rights reserved.
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
25 © Copyright 2016 Dell . All rights reserved.
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.
26 © Copyright 2016 Dell . All rights reserved.
Thanks [email protected]