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Installing MIS (I) - Internal Evaluation to create profile - identify Needs (PV, QA, GMA, Guidelines) - identify Environment (IT-based) - Build „Installation Team“ - As small as possible - only „Hands on“-people – No leaders/managers - include IT and QA (clearly a „must“!) - Ensure communication to all stakeholders Drug Information Association www.diahome.org Installing MIS (II) Choosing a MIS – a short checklist: IT : ! Hard- and Software, Access, Validation… QA: ! Audit of distributor, FDA etc. compliance, GAMP5, Validation…. Medical: ! Guidelines, Interface (PV or other internal systems), Hosting, scalability, flexibility, costs…. MIS: ! MIS on market: references, „Who meets your needs?“, choose 2 finalists, negotiate, document …choose your MIS!! Drug Information Association www.diahome.org
Installing MIS (III) Something about timelines… - Always ask for realistic timelines and list of milestones (references) - Consider fourpart interaction (D,IT,QA,Med) - add 10 weeks …… - Communicate milestones, not a date! Drug Information Association www.diahome.org Milestones 2010 - MIS contract signed (Feb. 2010) - Audit of distributor (Apr. 2010) - Global Team Meeting + Training (May 2010) - Installation completed (Jun. 2010) " ! Installation during 4 months! - Database online (Nov. 2010) - Internal Audit/Visit (Dec. 2010 – Feb. 2011) Drug Information Association www.diahome.org
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