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Medical Device Agile Quality Demo
1. Quality Demo – screenshots – medical equipment Todd Hein – Sr. Director, Medical Devices - Life Sciences IBU
2. FDA Requirements in one common datatbase : AgileMD Enterprise Quality Management (EQM) Differentiation – Leveraging PLM functionality across the enterprise FDA Quality System Audit “ Support Claims with Evidence” Integrated Quality Event Management The only true close loop system linking quality events to all enterprise records Global Product, Document, & Change Management All QMS/DHF/DMR/Submission records in one enterprise solution 1 2 Synchronized Project & Portfolio Management All regulated projects linked with global document & quality system 3 Open Standards based IT architecture Support integration across the enterprise IT platform 5 Enterprise Quality Analytics & dashboards Comprehensive DW schema to support Enterprise Quality Management Reviews 4
3. Cross System CAPA process / data flow ERP Agile CAPA Management Customer Complaints Create CAPA Analyze Root Cause Inventory Levels Customers Quality Analyst Support Close & Notify Create CCs Analyze SR Trends Analyze Cycle Time Prompt Actions/Alerts Quality Analytics Publish Product SRs Engineering Change Analyst Manufacturing Staff Containment Action Change Management Implement Change Notify Customer Stop Ship Ship to Locations Replicate CCs NCR’s Supplier Issues Audits CAPA 8D SOP’s DCO’s Documents Product ECO’s
8. Agile Quality Demo Scenario – 1.0 Customer Complaints Scenario – “screen flicker” CC – auto link to Final P/N & revision Q/A Define disposition & monitor status Auto create feature
9. Customer Customer Complaint Cover Page Captures details, severity, disposition and action taken
14. Agile Quality Demo Scenario – 2.0 Internal NCMR Scenario – “screen flicker” at functional test Q/A – auto link to sub assy P/N & revision Supplier notification Auto Product Risk assessment
43. Enterprise Value – AgileMD/ERP Integration Synchronizing design/mfg & regulatory content with change/quality history Automating the Prototype – Commercialization process to provide compliance integrity & business efficiency As Designed As Built ERP Agile DMR / Item Master Integration (Proto - Commercial) Design Analysis (Quality & Change Mgmt) MBR/DHR (Lot Info) Sale/Ship Info Procurement ($$ / Lead-time) Router & Inventory Pick NPD/DHF QMS Reg. Sub Design Change
51. Agile Quality Demo Scenario – 8.0 External Audit Mgmt Scenario External audit management One system for docs/parts change mgmt & quality Link to DMS & Cobra system 7.0 Comprehensive Reports 8.0 Enterprise Audit Mgmt
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63. PLM Process Dependencies Customer Complaint CAPA Stop Ship Change Order Deviation Non-Conformance
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Hinweis der Redaktion
Understanding that FDA audit practices are based on the systemic review of each of the subsystems of this graph*. Addressing and auditors enquiry into the historical activity in any of these subsystems requires an organization to manage these functions across each subsystem. Product Document and Change Mgmt. – (The 6:00 position on the graph) Is the foundation of the compliant dataset as this is the auditable repository to demonstrate appropriate management of all “historical claims and evidence” for each system. Quality Event Mgmt. – (the 12:00 position) is ALWAYS one system that is audited to confirm you have an intake system to triage all quality events and resolve them by assessing the quality event impact across each of the subsystems. Project & Portfolio Mgmt. FDA expects cross functional management for design control, mfg transfers, and even regulatory submissions. To demonstrate control of all these activities a project & portfolio management practices have to be enforced. Employee Training- This has emerged over the last 18-24 months as an audit target and requires a trigger from a change management system to be effective as all training is linked to the a companies FDA Regulations Quality Management System, plus the documents, processes, and procedures associated with product Management Reviews – With Management at the center of the subsystems FDA expects senior staff to consistent comprehensive review of each of these subsystems * All FDA auditors are trained on the QSIT – Quality System Inspection Techniques which this graph came from) requires that companies defined processes to support each of these sub-systems and audit to make sure management know what is going on
Agile is the Aggregator and CAPA Management piece (Web Svc??) Process and Data Flow CRM: Customer Complaints get created in Clarify. Web Services integration replicated product relevant Complaints in Agile. CAPA/BI: Complaints are analyzed in BI. Customer Complaint threshold triggers a notification to QA and Auto creates a CAPA in Agile and links the CC’s to the CAPA. CAPA/ERP: CAPA 8D process: View Affected items and Inventory levels (SAP integration) and initiate a Stop Ship to contain to quality issues. (SAP Integration). CAPA/ERP: Analyze root cause and initiate an ECO or DCO to resolve the issue. Publish ECO changes to SAP. CAPA/CRM: Close & Notify on CAPA resolution and notify update Clarity.
The Oracle BI Suite is a comprehensive, integrated solution that enables organizations to have a single business intelligence architecture that can simultaneously access and derive insight from a heterogeneous data sources – like: Historical data sources in data warehouses Real-time data stored in operational data sources and OLTP systems Data stored by various applications Data stored in Files, Excel, XML Data sources that are used by Business Processes The ability to access the data from the heterogeneous data sources is very important – as this is what enables the delivery of real-time, pervasive insight. The BI Server is a scalable, sophisticated data access, aggregation, and calculation engine for real-time intelligence across all these heterogeneous data sources. By nature the data sources will be different and it is critically important that these sources be brought together in a coherent way. Oracle BI provides a unified metadata that enables these sources to be modeled appropriately to provide insight that is personalized and relevant and not just display data. The unified metadata layer creates a common semantic for the data stored in the various data sources. This is critically important as this ensures that any insight derived and delivered from this is consistent – i.e. provides a “single source of truth”. Finally the insight is delivered in a personalized manner through various channels, like interactive dashboards, proactive detection and alerts, ad-hoc analytics, mobile analytics, real-time predictive analytics, advanced reporting, and integrated into other applications using Web Services
The attached slide (it's a build slide so please run it in presentation mode) shows the Agile MD/ ERP workflow and how that impacts DHF/ DMR. Typically, the "As-Built" for each individual product that is built is done in ERP (serial numbers, lot numbers, actual affectivity dates are added here) while the "As-Designed" or "As-Planned" for each product is done in Agile MD. Agile MD would be the master Change Management system that handles Revision control of parts and documents being replaced/added/deleted to the "As-Built" products that reside in EBS as a result of quality issues (or similar) that crop up. Agile MD would also be the master Closed-Loop Quality system that handles the containment, root-cause analysis, and move-forward plan to address quality issues affecting each product (CAPAs and related ECOs). The CAPA and ECO workflows and all resulting part and documentation changes would be managed in Agile PLM and the resulting new Revision of the updated "As-Planned" product would be passed to ERP through the out-of-box integration (PIP) where the actual product is finalized and built (updated serial numbers, lot numbers, affectivity dates are added)
Compliance eng (CE) analyzes BOM for RoHS, finds parts that are exempt, and missing data (BOM view and report) Runs query to find parts that do not have a declaration as a second check Review existing declarations, including IPC1752 and JGPSSI on parts Create declaration to gather missing information (Part Substance) RoHS for real time analysis pass/fail during entry Supplier enters data interactively, show undisclosed, partial, fully disclosed analysis for supplier Supplier adds a substance to get full disclosure, validates, maps to substance library CE evaluates results, publishes data CE runs a BOM rollup in Excel to get total substance data. CE shows top assembly with page three fields for demand, shipments to date for calendar year CE shows final report with Substance totals by application shipments to date and anticipated demand