Pfizer-Wingspan eTMF From Vision to Implementation Complete, Compliant, Consistent transformation CBI http://www.cbinet.com/ Pharma/Bio Boot Camp on Electronic Trial Master Files November 14-15, 2011 Philadelphia, Pennsylvania Introductions Troy Deck Principal at Wingspan [email protected] 610-941-6508 – work Susan Paul Pfizer, Director of Business Technology Responsible for TMF Agenda Project Origin Product Features & Architecture Product Screen Shots Project Success Factors Q&A Project Origin • Global Pfizer Strategic Innovation program TMF identified as a priority focus area for Pfizer innovation • Disciplined Requirements Process Pfizer spends 10 months redesigning business processes and documenting system requirements • TMF Vendor Selection Pfizer selects Wingspan as the most capable vendor and development partner. • Wingspan eTMF Design Wingspan spent 5 months refining requirements and producing a highly optimized design. • Rapid Construction 15-20 engineers, 75 joint project team, weekly meetings… • 12 month Execution with Phased Deliverables • Delivery date set in January 2011 for a production rollout 2011! Complete • At any point in time show what is missing, what is coming due, what is in workflow. – Dashboards – Reporting • Display how document manifest has changed over time for a study, country, site. • Display process owner group and which documents they are responsible for. • What is the rejection rate (goal is 4 sigma…99.38%) Consistent • Document type audit. In country level documents it went from 300 documents to 1. • The Master TMF Manifest has a process in which it can be modified or changed. • 100% QC on all documents. Compliant • • • • Are all required documents present? Audit ready at anytime. 21 CFR Part 11 compliant. New role: TMF Study Owner – Responsible for the electronic Study TMF. Project Structure 1 2 3 4 5 6 Functional Requirements Workstreams Content Capture & Document Scanning Study Setup User Interface & Security Quality Control and Activation Content Search & Records Management Metrics and Reporting 6 Work Streams 905 Requirements 156 119 107 78 69 63 User Interface & Security 592 Functional Requirements Content Capture, Study Setup, User Interface, Quality Control, Search, Metrics, etc. 313 Non Functional Requirements Compliance, Performance, Capacity, Support, Infrastructure, etc. Study Setup Metrics and Reporting Search & Records Management Quality Control and Activation Content Capture & Document Scanning Development Statistics • Over 30 development man years in the application. • Two teams of testers (2 man years of testing) – Team 1 from Wingspan – 6 Testers – Team 2 from Pfizer – 12-14 Testers – 3,000+ hours of testing • 8 development milestones set in January 2011. Met every milestone date. Production delivered November 11, 2011 at 11:11am. (4 days earlier than original date). • Design document approaching 1,000 pages. • Goal for IT was to make sure no built in Pfizerisms that cannot be changed via configuration. Pfizer wants this to become a product that is the standard for eTMF. Operating Statistics • Supports 1000 concurrent users • 1,350 Studies per year by 2015, unlimited studies total • 240,000 Documents per month • 60+ Countries with Access • 600+ Document types • Note: The most successful large scale program in R&D at Pfizer in over 10 years. Product Features • • • • • • NO FOLDER NAVIGATION 21 CFR Compliant Anticipates Documents CTMS Driven Wizard Based Configuration Efficient Content Capture and Quality Control • Metrics Reporting and Continuous Improvement • Extensible • Robust Capability and Technology RoadMap • • • • • • • Robust Alerting Audit Trails Renditions OCR and Barcodes Search Site Master File Reconciliation Milestone Report, Operational Reporting/Dashboards • Workflows • Role Based Permissions • 100+ screens in system. Process Steps Receipt & Scan OCR & Render QC & Correct Index & Store • • • • Mail-In Documents Scan at Office Upload Files eMail Attachments • • • • • Document Type OCR Deskew DeSpeckle Render PDF • • • • Validate Scan Validate OCR Validate Field Data Correct if Needed • o o Wingspan cTMF Captiva o o Wingspan cTMF ADLIB, Captiva o Wingspan cTMF o o e • Monitor & Report Add Additional Data Validate Study Association • • • • • • Percent Complete Missing Documents Late Alerts Issue Reminders Advanced Search Metrics Wingspan cTMF Documentum o Wingspan cTMF Product Architecture • • • • • Components Scale Independently Driven by CTMS Integrations Standards Based Loosely Coupled Extensible ALTERNATE-2 eTMF UI (Wingspan) Authentication Services Access Management Authorization Services Presentation User Interface FAST Search Application eTMF Imaging (EMC) DMF Study Setup Quality Control & Activation Reporting Study Closeout User Interface Content Capture & Creation Search Workflow Content Search Logging/Auditing Rendition Data Storage Data Storage Data/Content Clinical Data Warehouse Content Management Blue Existing Systems/Components Red New Systems/Components Product Screen Shots Choose top n Capabilities/Features and provide screen shots for them. Enterprise Metrics Study Metrics Document List View Messages & Tasks Document Indexing Project Success Factors Make the project fixed bid. Builds discipline and accountability. Manage Scope, Manage Scope, Manage Scope 84 Change Orders evaluated. 4 Approved for R1, 8 Approved for R1.1 CR Filter Is their a work around? Is it required for regulatory? Lock the requirements Start with really smart driven people. Pfizer TMF Process Owner: Ivan Walrath. Work with really smart driven people. Wingspan & Pfizer team Finish with really smart driven people. Wingspan & Pfizer team – Consistency of personnel on the project. No change of personnel on Pfizer’s or Wingspan’s team from the start. Questions? Susan Paul Troy Deck [email protected]
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