西门子数字化企业研发管理套件助力医疗器械行业合规控制方案
张治平Jason Chang, PLM Siemens
医疗设备行业的业务模型
设计制造一体化需求管理零件管理BOM配置管理电子化DHF/DMR管理纠正, 防错及客诉管理项目及资源管理
机电软集成项目时程管理工艺规划模拟与测试验证变更管理合规遵循风险管理需求追溯协同化产品开发共应商协同集成质量管理W E B 服务标准化数据交换与连接Vendor SystemsReference DatabasesOther Data SourcesERPMESCustomer SystemsEmbeddedSoftwareemCADCADCAEPlant DesignPlant Visual.Process Design & Simulation企业系统生产系统价值链系统专业工具FDA要求什么？生命科学公司需要一个全面而合规的数据集
FDA Quality System AuditCorrective &PreventiveDesign ControlsActionsProduction & Process ControlsManagementMaterialEquipment & ControlsRecords,Facility ControlsDocuments, &Change Controls“Support Claims with
Evidence”
Operational Functions Required:1Product, Document, & Change ManagementSecure collaboration in the development and management of the complaint dataset2Quality Event ManagementClose-loop impact of quality on product, process or policy3Project & Portfolio ManagementReal-time visibility and portfolio analysis of all projects across enterprise4Employee TrainingSynchronized employee training with document and process changes5Management ReviewAutomated reports and analytics to support business decisions3FDA要求什么？生命科学公司需要一个全面而合规的数据集
FDA Quality System AuditCorrective &PreventiveDesign ControlsActionsProduction & Process ControlsManagementMaterialEquipment & ControlsRecords,Facility ControlsDocuments, &Change Controls“Support Claims with
Evidence”
Impact on Industry:?FDA Audit focus
?CAPA plus one other system?Design Control
?Risk Management
?Financial and Business impact of non-compliance is staggering
?Multi-million dollar fines?Market share erosion
?Companies are prioritizing on compliance
?ie. Stryker executive compensation linked to compliance performance
4PLM Foundation -“符合规范的数据”由QMS定义的所有数据
Design History File(DHF)?General?Planning?Design Input?Design Output?Design Review?Design Verification?Design Validation?Design Transfer?Design ChangesRisk Management(Risk Mgmt)?Standards
?Quality Event Management
?Customer Complaints?CAPA?MDR?Audits
?Product Risk Management
?FMEA
?Test Reports?Clinical Reports
?System Validation
DMRDHFQMSQuality Management System(QMS)?FDA part 820 SOP?ISO 13485 SOPDevice Master Record(DMR)
?Device Specifications
?MfgProcess Specification?Q/A Specifications
?Pkg& Label Specifications?Install Specification
?Maintenance Specification?Service SpecificationsRegulatory Assurance(R/A Docs)
?General Information ?Indications for Use ?Device Description
?Warnings and Precautions ?Manufacturing Processes?Marketing History/Articles ?Risk Mgmtand Design Testing?Preclinical Studies/Articles?Summary of Clinical Studies ?Labeling?IFU
RiskMgmtR/ADocs5
04 西门子数字化企业研发管理套件助力医疗器械行业合规控制方案
