Archive strategy for electronic records Peter Fæster Nielsen, Novo Nordisk 13. May 2014

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1 Digitale arkiver - Vedligeholdelse, tilgængelighed og forskning 13. maj 2014 på Rigsarkivet Archive strategy for electronic records Peter Fæster Nielsen, Novo Nordisk 13. May 2014

2 Peter Fæster Nielsen, archive strategy at NN May Novo Nordisk at a glance Approximately 40,000 employees in 75 countries Products marketed in 180 countries A world leader in diabetes care since 1923 Also leading positions in: Haemostasis management Growth hormone therapy Hormone replacement therapy

3 Peter Fæster Nielsen, archive strategy at NN May Organisation President & CEO Lars Rebien Sørensen R&D Marketing & Medical Affairs Finance, Legal & IT Operations Corporate Relations IT, Quality & Corporate Development Quality Operations Records Management

4 Peter Fæster Nielsen, archive strategy at NN May Archiving electronic records - why? Compliance with retention rules QA Reduce storage costs IT For e-discovery purposes Improve system performance preserves corporate memory Legal Records Management IT Regulatory compliance Documentation to authorities Long-term securing of data integrity QA QA Uniform management of business-critical information Save evidence in case of litigations Facilitates data migration Legal Records Management Legal QA, Records Management IT

5 Peter Fæster Nielsen, archive strategy at NN May The way to a successful records management (RM) programme IT RM Legal QA

6 Peter Fæster Nielsen, archive strategy at NN May Landscape for physical Business Critical Records Multiple physical archives One RM system Procedures: File plans (business process catalogues) SOP Governance: Global Retention Group ONE archive system Scope: and physical records

7 Peter Fæster Nielsen, archive strategy at NN May Archive System - definition Storage Records management Archive system A Access and security Data backup and restore Data authenticity and integrity Validation or Test Retention and Destruction Legal Hold management Retrieval and Indexation Readability Segregation of duties B C ENV/JM/MONO(2007)10 21 CFR Part 11 Electronic Records; Electronic Signatures

8 WHAT Peter Fæster Nielsen, archive strategy at NN May

9 Peter Fæster Nielsen, archive strategy at NN May Strategy Vision; the to-be situation Leverage record management for to the same level as records management for physical documentation RM

10 Peter Fæster Nielsen, archive strategy at NN May Strategy elements Data/document type dedicated archives for One generic archive system for various file types Possible to initiate retention in live systems

11 Peter Fæster Nielsen, archive strategy at NN May Strategy for archiving of electronic records () Create Time Electronic Record Active In-active As is Situation for the majority of NN systems Systems & Processes Live system

12 Peter Fæster Nielsen, archive strategy at NN May Strategy for archiving of electronic records () Create Retention start Event: e.g. system upgrade or retire Retention end Time Electronic Record Active In-active Retention period In-active Archived To As be is Systems & Processes? Archive System Live system Archive evaluation Deletion

13 Peter Fæster Nielsen, archive strategy at NN May Strategy elements - readability Long term readability decisions Long term readability are not secured through archiving of hardware and software Data is preferred to be viewed in the original format through the software used to create the data Prior to decommissioning of a system - future readability are secured through: Migration of data to a new system or Converting data to a human readable version (e.g. PDF) (only if the conversion preserves the accuracy, completeness, content and meaning of the original data)

14 How Peter Fæster Nielsen, archive strategy at NN May

15 Peter Fæster Nielsen, archive strategy at NN May Implementation of archive strategy eg. SOP: Records Management of Business Critical Electronic Records Workflow/process description for System Owners and Data Owners: Define 3 different storage levels (incl. Definition of an Archive System ) Describe the process for evaluating records in order to decide suitable storage level Describe method to evaluate an IT system in order to determine on which storage level the IT system can store or archive records

16 Peter Fæster Nielsen, archive strategy at NN May Implementation of archive strategy eg. SOP: Records Management of Business Critical Electronic Records Data Owner Business Process generate data Decide storage level for data B C A RECORDS SYSTEM CONCLUSION Level C Actions TBD Level B Level A Actions TBD OK Level C Level B Level A Actions TBD OK OK Sys Owner Level C OK System evaluation C B Level B Level A OK OK A

17 Case Peter Fæster Nielsen, archive strategy at NN May

18 Peter Fæster Nielsen, archive strategy at NN May Case example - Archive system for GLP raw data File Capture Print Capture Instruments SDMS Data Management Systems Storage Records Management DMS DMS GLP Access control Data backup and restore Securing data authenticity and integrity Retention & Deletion Legal Hold management Retrieval & Indexation standard Readability Archive Reports DMS Contract Research Organisations SDMS

19 Peter Fæster Nielsen, archive strategy at NN May Initiatives related to archiving of : The Document Retention Programme: Development of a global process based file plan Establishment of a Global Retention Schedule : Global roll out of the OmniRIM system for physical records 2011: Guidelines for: Differentiation of storage levels defined for IT systems Deletion of non critical s before they pass 3 yrs. Deletion of Backup tapes after 3 yrs : Pre analysis of GLP archive solutions for electronic records : GLP programme (GLP electronic records) Implementing an archive system for electronic GLP data (SDMS) Upgrade of global Document Management system to an archive system Definition of roles, responsibilities and requirements 2013: Pilot for compliance scanning established

20 Peter Fæster Nielsen, archive strategy at NN May

21 Readability strategy for instruments Peter Fæster Nielsen, archive strategy at NN May

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