質(zhì)量體系的分析研究-展示頁(yè)
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【正文】 ation and business rules ? Integration to external systems ., Create deviations automatically from ERP ., Create OOS Investigation from LIMS Master data (customer, product/item, etc.) External Systems Data Management 28 Workflow Management ? Configurable workflow Automate review and approval process based on meta data Businessrule based workflows Parallel Approvals Process changing activity Email notifications ? Integrated source areas process to Corrective Action process Parent – child relationships Cross referencing Workflow External Systems Data Management 29 Escalations and Business Rules ? Business rules enforcement Date Due, Milestone Dates Automatically assigning investigators, reviewers, approvers Automatically scheduling tasks based on type of Record ? Escalation “Reminders” of tasks reaching expected pletion date Escalation of CAPA past due Workflow External Systems Data Management Business Rules Escalation 30 Query, Reporting, Trending Workflow External Systems Data Management Business Rules Escalation Search, Report, Trend ? Querying Ability to query on all fields Full text / search engine functionality Ability to save searches ? Reporting Customizable report format On screen view, print, , save Status reporting ? Trending Across all sites Across all source areas Root cause analysis Identify occurrence rate decrease / increase Ability to detect trends automatically 31 Compliance with Part 11 ? Does the system conform with your firm’s Part 11 requirements? ? Has the software “passed” the test, ., has it gone through FDA audits at another firm? ? Can it be validated? ? How confident are you in the above assessment? ? Full audit trail ? Reporting features ? Configurable security groups ? Complete record of created and modified data ? Enforced workflow sequencing ? Password position rules ? Electronic Signatures made up of two unique ponents ? Password aging/expiration ? Cannot reuse previous password ? Account Locking and Admin Notification after failed login Attempts ? Session timeout ? Requirement of “reason” for data modification ? Administrator / Configuration Audit Trail 32 Implement Solution Quality, Operations, IT Structured Project Organization Customer – System Administrator Implementation Consultant Project Management Customer Executive Sponsor Sr. Mgmt. Support Business IT Project Mgr. Vendor Project Manager Project Team ? Change Management ? Validation Partners ? Operations management Vendor SMEs QA Customer Satisfaction Technical Support LAN/WAN DBA Servers Customer IT Sponsor Medtronic Leads: Medtronic Leads: Customer. Owner Team ? CAPA ? Complaints ? Audits ? RMAs ? Others Steering Committee ? Internal Computer Systems Validation ? Vendor ? 3rd Party (remended) Validation Team Vendor Administrative Resources 34 Rapid ROI Phased Approach Critical Systems Prioritization Phase1: FIRST QMS Configure, Prototype, Train Validation Phase2: Additional QS Implementation, Configure, Prototype, Train DATA Migration Systems Integration Reduced Validation via Migration tool Fully integrated CAPA Initial ROI / Business and pliance Benefits Roll out – Production Additional QS Yes No Prioritized QMS List and implementation Project Plan Go Live! 35 ? Project Team Workshop2 ? Finalize Configuration Design ? Reports Customization ? Train on Validation Templates ? Develop Validation Protocols ? Complete setup of integration tools ? Develop User Requirement Definition ? Functional specifications ? Initial validation activities ? Product Orientation
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