Arian RajhAgency for Medicinal Products and Medical Devices

Ph.D. Hrvoje Stančić, assistant prof.Department of Information Sciences, Faculty of Humanities and Social Sciences

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Contents

Applicable methodologies for planning and designing of DAIS

ISO 15489 and DIRKS based planning and designing

PRINCE2 and PCM based planning and designing

Comparison of applicable methodologies

DAIS as IPA project

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Applicable methodologies for planning and designing of DAIS

DAIS could be planned and designed through recordkeeping (ISO 15489 and DIRKS) or project management methodologies (PRINCE2 and PCM)

Aim: comparison of the methods recommendations

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ISO 15489 and DIRKS based planning and designing

ISO 15489:2001 for Records management scope: recordkeeping – recordkeeping

systems (DAIS), recordkeeping policies, compliance with quality management

applicable subordinated standards are ISO 23081 Metadata for records and ISO/TR 26122 WP analysis for records

outlines methodology methodology is elaborated in detail in DIRKS

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ISO 15489 and DIRKS based planning and designing …

Phases of methodology:1) Preliminary investigation2) Analisys of business activity3) Identification of recordkeeping

requirements4) Assessment of existing systems5) Identification of strategies for

recordkeeping6) Design of recordkeeping system7) Implementation8) Post-implementation review

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PRINCE2 and PCM based planning and designing

PRINCE2 (Project IN Controlled Environment) Phases of methodology:

1) Start up the project2) Directing a project3) Initiating a project4) Management of stage boundaries5) Controlling a stage6) Managing project delivery7) Project closing8) (Planning phase)

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PRINCE2 and PCM based planning and designing …

PCM (Project Cycle Management) phases of methodology

1)Programming2) Identification3)Formulation4) Implementation5)Evaluation

PCM is a methodology suitable for development and for selection of projects logical matrix tool

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Comparison of applicable methodologies

Division of methodologies into wider common phases by “common delimiter” phase boundaries – according to the issues

that need to be assessed during lifecycle of potential digital archive▪ stated problem (initial phase)▪ proposed solution (planning phase)▪ planned activities (designing and implementation

phase)▪ results of the implementation (final and post

implementation phase)

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Comparison of applicable methodologies …

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Comparison of applicable methodologies …

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Comparison of applicable methodologies …

ISO & DIRKS – strong planning planning system and records management

politicsPRINCE2 – strong activity development

good for projects which are certain to be carried out

PCM – strong initial phase delivering the project idea project “go – no go” decision

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Comparison of applicable methodologies …

selection of methodology depend on estimation of the most critical phase in

setting up the particular digital archive current state of affairs in organisation in

which the archive will be established designers of the digital archive must

recognise potential risks in advance possible usage of more than one

methodology

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DAIS as IPA project

IPA 2009 TAIB project Preparations for eCTD and development of DAIS

Agency for Medicinal Products and Medical Devices is Croatian NCA for regulation of medicines – beneficiary of the project

Objective: to work electronically with eCTD records and to establish reliable digital archive

Critical phase is financing and approval Developed through PCM Application for IPA financing

building administrative capacity and strengthening beneficiary’s co-operation with EU NCA based on sharing common standards (eCTD)

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Planning and Designing of Digital Archival Information Systems

Arian RajhAgency for Medicinal Products and Medical Devicesarian.rajh@almp.hr

Ph.D. Hrvoje Stančić, assistant prof.Department of Information SciencesFaculty of Humanities and Social SciencesUniversity of Zagrebhrvoje.stancic@zg.t-com.hr