Data and Documents in Pharmaceutical & Life Sciences Marko Javanainen S a l e s d i re c t o r mhealth 18.11.2013
M-Files Corporation WE ARE LOCATED IN FINLAND & TEXAS Over 150 employees Leading ECM software Over 500 customers in Finland Customers in more than 100 countries M-Files is used in all industries
Award winning M-Files Technology Gartner Magic Quadrant for Enterprise Content Management 2012 ja 2013 Forrester ECM Wave 2013 KMWorld: Trend-setting Product of 2012 Info-Tech Content Management for Knowledge Workers Vendor Landscape -raportti 2012: Market Pillar Ruban d'honneur European Business Awards - kilpailussa 2011 Deloitte Technology Fast 50 Finland ja 500 EMEA - finalisti (2010, 2011 ja 2012) Red Herring 100 Global -finalisti 2010
Why Content Management? Data growth 2013 2014 2015 2016 2017 2018 Data will grow 44X in 10 years 1) IDC 2010 Digital Universe Study Only 30% of knowledge workers have an access to relevant data
80 % of business data is in documents only 20 % is in databases IDC & DMA 85 % of documents are never used 60 % are obsolete 50 % are copies University of Jyväskylä Average employee wastes up to 20 % of his time for searching documents Every second time employee does not find what he is searching Kevin Craine: Design a Document Strategy
Net drives Desktops E-mails Prints Databases Dynamic Content Management Cloud Hybrid On-Premise
Quality Management (QMS) Document Management (DMS) Enterprise Asset Management (EAS) Contract Lifecycle Management (CLM) Human Resources Management (HR) Customer Relationship Management (CRM) Sales and Pipeline Management Project Management Customized Solutions
CASE QUALITY MANAGEMENT METADATA-POWERED INFORMATION MANAGEMENT
Three Approaches to Quality Meet quality certification requirements ISO 9001, ISO 13485, CE labeling, etc. Must comply with law or regulations Pharmaceutical, healthcare, aviation, petrochemical, etc. Employees, clients or the environment at risk if quality fails Rigorous quality processes and dedicated quality personnel Audited repeatedly Internal reasons Demanding, quality-intensive products or services Quality flaws bring risks of financial loss, missed timelines or reputation damage
Why a Dedicated Quality Management System? Share all quality information Essential data not buried in spreadsheets, emails or paper files Share calendar and database data Control essential documents Make sure everyone uses the correct versions Get quality tasks done on time Drive the quality processes with a good system, instead of just recording results once you have them SOP reviews, mandatory trainings, maintenance due dates, CAPA deadlines etc. Make system aware of key dates so they appear on common calendar, and reminders can be sent automatically
Why a Dedicated Quality Management System Get evidence about your policies are actually being followed Document Control is just the first step! Easily record all completed tasks Get accurate and up-to-date information on your quality performance Open issues, overdue tasks, average time needed for corrective actions etc. Survive personnel changes Find past personnel's documents, emails, responsibilities and open tasks
M-Files QMS A solution for daily quality management Not just a static quality manual or SOP publishing system All typical quality processes out-of-the-box Quickly tailored to each client during implementation Repository for all related documents and emails Award-winning M-Files technology Combine documents and database data in one system M-Files QMS helps you to follow your own quality policy 12
KIITOS! Marko Javanainen Sales Director M-Files Corporation marko.javanainen@m-files.com +358 45 263 2599