Arian Rajh Agency for Medicinal Products and Medical Devices Ph.D. Hrvoje Stančić, assistant prof. Department of Information Sciences, Faculty of Humanities and Social Sciences

2 Contents  Applicable methodologies for planning and designing of DAIS  ISO and DIRKS based planning and designing  PRINCE2 and PCM based planning and designing  Comparison of applicable methodologies  DAIS as IPA project

3 Applicable methodologies for planning and designing of DAIS  DAIS could be planned and designed through recordkeeping (ISO and DIRKS) or project management methodologies (PRINCE2 and PCM)  Aim:  comparison of the methods  recommendations

4 ISO 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 Metadata for records and ISO/TR WP analysis for records  outlines methodology  methodology is elaborated in detail in DIRKS

5 ISO and DIRKS based planning and designing …  Phases of methodology: 1) Preliminary investigation 2) Analisys of business activity 3) Identification of recordkeeping requirements 4) Assessment of existing systems 5) Identification of strategies for recordkeeping 6) Design of recordkeeping system 7) Implementation 8) Post-implementation review

6 PRINCE2 and PCM based planning and designing  PRINCE2 (Project IN Controlled Environment)  Phases of methodology: 1) Start up the project 2) Directing a project 3) Initiating a project 4) Management of stage boundaries 5) Controlling a stage 6) Managing project delivery 7) Project closing 8) (Planning phase)

7 PRINCE2 and PCM based planning and designing …  PCM (Project Cycle Management)  phases of methodology 1) Programming 2) Identification 3) Formulation 4) Implementation 5) Evaluation  PCM is a methodology suitable for development and for selection of projects  logical matrix tool

8 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)

9 Comparison of applicable methodologies …

10 Comparison of applicable methodologies …

11 Comparison of applicable methodologies …  ISO & DIRKS – strong planning  planning system and records management politics  PRINCE2 – 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

12 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

13 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)

14 Planning and Designing of Digital Archival Information Systems Arian Rajh Agency for Medicinal Products and Medical Devices Ph.D. Hrvoje Stančić, assistant prof. Department of Information Sciences Faculty of Humanities and Social Sciences University of Zagreb