Implementing Records Management in a Multinational Company

Global Records Management & Archiving

Implementing RM In A Multinational Company J端rg Hagmann ECM-ILM-RM, April 2006, Baden Disclaimer: This document contains official Novartis policies. Do not distribute or copy this presentation.

Novartis @ A Glance

Global RM&A

• 360 independent affiliates, > 81’000 employees • Located in 140 countries • 3 Divisions Ö Novartis Pharma • General Medicine • Special Medicine Ö Sandoz • Generics Ö Novartis Consumer Health • OTC (Over-the Counter) • Animal Health • Medical Nutrition • Infant & Baby • Ciba Vision

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Background: Why Global RM&A • • • •

Assist in continuing conduct of business Meet legal & regulatory requirements (compliance) Prevent risk in litigations and criminal investigations Provide necessary accountability: e.g. SOX

Ö Global competence center responsible for records management and archiving under consideration of all aspects:

Global RM&A

Business Legal

Regulatory Aspects

Security

Organizational Technical

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Group Records Management Policy

Global RM&A

The Charter of Global RM&A

• Manage/coordinate corporate records management strategy • Develop, publicize, maintain standards, guidelines and training material for records management • Promote awareness and requirements of good practices • Coordinate with Group companies as required for the development and implementation of local records management programs

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Records Management Program Components • Normative framework Ö policy, standards, guidelines, procedures

• Records schedule

Global RM&A

Ö Ö Ö Ö Ö

records inventories catalogue of legal requirements classification of records records ownership retention schedules

• Naming and indexing conventions • Records management processes Ö Preservation and destruction of records

• Hold management • Global tools • Enforcement Ö Monitoring and auditing

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Global RM&A Organization & Roles Head Pharma Division

Group Legal Counsel

Head Global Quality Operations

RM&A Coordinators in Countries & Functions

Global RM&A

Strategy & Program

Service & Account Management

Global RM&A

Education, Training, Consulting & Support Business Architecture & Technical Mgmt

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Records Management Normative Framework Index & Metadata Management Communication, & Liaison Mgmt

Objectives Objectives

Compliance Compliance Business BusinessContinuity Continuity Evidence Evidencein inInvestigations Investigations Risk RiskControl Control Accountability Accountability//Efficiency Efficiency

Services

Global RM&A

Normative Normative Framework Framework

7

Strategies/ Strategies/ Solution Solution Definition Definition

Services Services & & Tools Tools

Areas to Be Addressed • • • • • • • • • • •

J.Hagmann, Baden, April 2006

Definition of Records?

Records Inventory Ownership Retention Requirements Records Schedule Access of Records Records Life-cycle Management Integrity & Authenticity Legal Discovery Disposition Process Hold Management

Services Competence Competence Center Center

Awareness/ Awareness/ Training Training

Project Project Support Support

Global RM&A Network Managed by Global RM&A

Global RM&A

Country 1

Country n

Country RM

Legal Entity 1

Legal Entity 2

Legal Entity n

Company RM

Bus. Func. 1

Bus. Func. 1

Bus. Func. 1

Function RM

Bus. Func. 2

Bus. Func. 2

Bus. Func. 2

Operational RM

Bus. Func. n

Bus. Func. n

Bus. Func. n

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(global & local) (local)

Records Management Organization Steering Group Legal, Regulatory, Compliance, Security, IT

Group level

Global RM&A • • •

Corporate RM Program Normative framework Global RM solutions

Global RM&A

Country/Company Records Managers

Country Level

•

Country specific requirements

•

Functional requirements

•

Responsible for operational activities

Functional Records Managers Operational Records Managers

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Responsibilities for RM Work Products Policy Standards (Manual Modules) Implementation Guidelines

Global RM&A

Global RM&A

Services & Tools Records Inventory

What records exist?

Requirements Catalogue

Why records are kept?

Records Schedule

When can records be eliminated?

File Plans

How records are captured and kept

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Country/Company/ Functional/Operational Records Managers Global RM&A provides Tools & templates

How to prepare a Records Schedule (1h)

Awareness Sessions

CBT: RM Overview

Specific training modules

Instructor-led training CBT‘s: - Guidance for records scheduling - Records inventory - Requirements catalog - Records schedule - File plan Instructor-led training on demand

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Implementation level / time

Followed by a specific training unit

Instructor-led learning

Awareness Sessions

Blended learning

Roll-out phase 2

Global RM&A

Roll-out phase 1

Education & Training Strategy

Challenges Organizational Structure • Large enterprise – cross-divisional, cross-country • Global vs Local – harmonization, synergies • Country-specific legislation – local requirements

Global RM&A

Implementation Business • Awareness/Training • Resources with the right expertise • Enforcement IT • Global/cross-functional strategy & solutions -harmonization, synergies • IT Support for Records Management • Cross-functional charge-out of services

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Benefits Enterprise • Consistency → Transparency and operational efficiency • Compliance → Efficiency in business, regulatory and legal proceedings • Synergies → Cost savings, efficient global operation

Global RM&A

• Optimized Risk Control Personal • Improved working environment

Ö Transparency and order: No time wasted looking for records Ö No piles on the floor or in file cabinets and less stress for everybody

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Your documents of today are the assets of tomorrow!

Do not neglect them!

Thanks for your attention!