How to Implement a Successful e-archiving Function Within a Multinational Company

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Clemence Smith
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How to Implement a Successful e-archiving Function Within a Multinational Company Huguette BESSARD Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the

1 How to Implement a Successful e-archiving Function Within a Multinational Company Huguette BESSARD Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 1

2 Agenda Co-ordinating the differing laws, regulations, professions, cultures Federate employees and harmonising practices Selection of the most appropriate technology that will fit all records types and allow a consolidated e-archiving strategy with an evidentiary status A Diversified Healthcare Company Vaccines (1) OTC / OTX (2) Medicines (3) Sales: 2,861m, +9.6% Sales: 1,272m, +21.8% (non consolidated) Market Share: 21.8% Rank : #1 Sales: 1,415m, +5.3% Market Share: 2,1% Rank: #6 Sales: 22,943m, +2.9% Market Share: 4.8% Rank: #4 Animal Health (4) Generics (5) Sanofi-aventis Group profile Merial sales: (non consolidated) Sales: 349m, +8.7% $2,643m, +7.9% Market Share: <1% Market Share: 14% Rank: #23 Rank: #3 Note: Sales figures correspond to FY2008 sales; growth is on a comparable basis except for SP MSD and Merial where growth is on a reported basis 2008 sales : 27,568 million N 4 worldwide with double-digit growth in the US and Japan N 1 in Europe, with double-digit growth in emerging markets Present in more than 100 countries Almost 100,000 employees (1) Vaccines market share based on sanofi pasteur internal estimate at the end of Dec 2008 and on worldwide presence including 50% of Sanofi Pasteur MSD joint venture sales (2) OTC/OTX market share and ranking - source Nicholas Hall, 2007 (3) Rx Drug market share and ranking from internal analysis based on IMS MIDAS MAT Q (4) Animal Health market share and ranking based on 2007 public data Merial is a 50/50 joint venture with Merck (5) Generics market share and ranking from internal analysis based on IMS MIDAS MAT Q

Principal products Cardiovascular Diabetes Thrombosis Oncology Central Nervous System Cardiovasculaire Diabète Thrombose Internal Medicine Vaccines Influenza vaccines (1), Polio/Whooping i cough/ Hib

3 Principal products Cardiovascular Diabetes Thrombosis Oncology Central Nervous System Cardiovasculaire Diabète Thrombose Internal Medicine Vaccines Influenza vaccines (1), Polio/Whooping i cough/ Hib Vaccines Meningitis/Pneumonia Vaccines, Adult Booster Vaccines, Travel and Other Endemics Vaccines, other Humans Vaccines OTC and generic 5 5 E-archiving, a strategic field S-A wants to commit itself e-records production Legal and regulatory framework Almost all records are generated electronically Records management still in its infancy (except some countries) Incomplete, wrong or unavailable e-records descriptions Paper culture remains prevalent in our company / electronic culture still struggles to take hold The legal and regulatory framework evolves worldwide e-records may have the same evidentiary value as paper documents Difficulties in applying the reference texts especially when they impose disproportionate retention periods Technology 6 Use of various computer systems to create e-records Electronic systems which created the e-records quickly obsolesce Media Proprietary formats Software Hardware Sustainability develops us in our behavior 3

4 Starting point From an internal inquiry e-archiving a building site to be initiated Concept of e-archiving remains confused Amalgamation of e-archiving, storage and backup Strong expectation of a single corporate policy to initiate e-archiving operations at the country level Project approaches Absence of coordination IS/RM 2 separate worlds Archivists /RM systematically excluded from the projects Reference texts (laws, regulations, ISO norms) In profusion Conformity to them is essential (for evidence/usability through time) 7 Set up an organization E-archiving Expert, a single position E-archiving Committee Role : Policy Guardian, makes it evolved, compensate for the lack of resources in that field E-archiving Expert : Facilitator Federates the Committee, suggests proposals Representatives : Cross-Activities Functions Countries Company-wide representation to take the overall issue into account Profiles such as IS, Quality, Records Managers, Archivists, lawyers R&D Pharma Operations Corporate Functions Industrial Affairs Vaccines 8 4

5 The e-archiving policy, a compromise solution of different international reference texts Laws / Regulations Resolution 51/162 Commission of the United Nations for the Right of International Trade (C.N.U.D.C.I.) on e-trade: Requirements related to the legal conservation of the e-documents in particular by the means of third-party archiving programs. French Law of 13/03/2000: Adaptation of the right of the proof to information technologies and the electronic signature 21CFR part 11: E-records, e-signature Sarbanes-Oxley Act: impose the installation of an e-archiving system allowed to know the financial history of the company ISO Norms 15489: Records Management, 18492: Long Term preservation of electronic document-based d information, 14721: Open model Archival Information System (OAIS) Good practices MoReq2: Model for the management of e-records Good Laboratory Practice - GLP: 8 defines e-archiving and the role of the archivist 9 The e-archiving policy Based on the reference texts, cornerstone of e-archiving The e-archiving policy affixes the rules guaranteeing the vital or legallydefensible evidentiary value of e-records throughout their retention period. Based on 4 main characteristics to maintain e-records Authenticity integrity Reliability Usability Describes the security measures to put in place from their capture to the e-archives until final disposition Provides definitions of terms Policy effective in January 2009 Dissemination to the main actors concerned esp.is, archivists/rm 10 5

6 E-archiving tool requirements Solution that accepts different e-records types (structured & unstructured data) Office documents s having a record status ERP records Consolidation of the company documentary production in a single environment Integration with Windows Deduplication of records Management of the retention ti periods Electronic vault Facilitate e-discovery 11 Sources ERP s GED Other Application s Legal Archiving Referencing Life cycle Storage Access Auditors Archivists Storage Secure storage Secure storage Secure storage 12 6

7 Monitoring of technological development Benchmarking with the principal i vendors Difficulties in evaluating the validity of the solutions proposed Weak anteriority of the solutions Commercial software? Or internal solution Company recommendation Scrutinize the existing company e-archiving solution 13 Next steps Tests performed on the existing tool and the results presented to the Upper Management Next steps : Prepare a feasibility study based on an advanced version taking the main enhancements into account. The aim of this study is to demonstrate if this internal solution can be extended to the rest of the company Benchmark the market solutions at the same pace Results of these 2 actions in June

8 Lessons learned The process is underway but Communication is vital Remain unbiased, not influenced by personal interests of other people Maintain a right balance with IS people Remain constantly up to date on this topic and always go into several lengths lead 8

Project Management Standards Applied to Complex Clinical Trials. Disclaimer

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