Digitale arkiver - Vedligeholdelse, tilgængelighed og forskning 13. maj 2014 på Rigsarkivet Archive strategy for electronic records Peter Fæster Nielsen, Novo Nordisk 13. May 2014
Peter Fæster Nielsen, archive strategy at NN May 2014 2 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
Peter Fæster Nielsen, archive strategy at NN May 2014 3 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
Peter Fæster Nielsen, archive strategy at NN May 2014 4 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
Peter Fæster Nielsen, archive strategy at NN May 2014 5 The way to a successful records management (RM) programme IT RM Legal QA
Peter Fæster Nielsen, archive strategy at NN May 2014 6 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
Peter Fæster Nielsen, archive strategy at NN May 2014 7 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
WHAT Peter Fæster Nielsen, archive strategy at NN May 2014 8
Peter Fæster Nielsen, archive strategy at NN May 2014 9 Strategy Vision; the to-be situation Leverage record management for to the same level as records management for physical documentation RM
Peter Fæster Nielsen, archive strategy at NN May 2014 10 Strategy elements Data/document type dedicated archives for One generic archive system for various file types Possible to initiate retention in live systems
Peter Fæster Nielsen, archive strategy at NN May 2014 11 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
Peter Fæster Nielsen, archive strategy at NN May 2014 12 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
Peter Fæster Nielsen, archive strategy at NN May 2014 13 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)
How Peter Fæster Nielsen, archive strategy at NN May 2014 14
Peter Fæster Nielsen, archive strategy at NN May 2014 15 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
Peter Fæster Nielsen, archive strategy at NN May 2014 16 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
Case Peter Fæster Nielsen, archive strategy at NN May 2014 17
Peter Fæster Nielsen, archive strategy at NN May 2014 18 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
Peter Fæster Nielsen, archive strategy at NN May 2014 19 Initiatives related to archiving of 2007-2008: The Document Retention Programme: Development of a global process based file plan Establishment of a Global Retention Schedule 2009-2013: 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 emails before they pass 3 yrs. Deletion of Backup tapes after 3 yrs. 2011-2012: Pre analysis of GLP archive solutions for electronic records 2013-2014: 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
Peter Fæster Nielsen, archive strategy at NN May 2014 20
Readability strategy for instruments Peter Fæster Nielsen, archive strategy at NN May 2014 21