35%
周期时间加快
100%
可追溯性
零
纸质日志
24/7
实时可见性
端到端流程
从发起到关闭的结构化工作流,在每个阶段均设有内置合规检查点和法规可辩护性。
从批次记录、实验室事故、投诉或审计中自动或手动发起偏差,并预填充上下文信息。
AI 赋能分类为关键、重大或次要,并自动进行风险评分和优先级分配。
使用石川图、5-Why 或故障树工具以及引导式调查模板进行根本原因分析。
评估对产品、批次和流程的影响,包含自动批次保留触发和交叉引用检查。
定义并分配纠正措施,包含证据要求、截止日期和多级审批工作流。
最终 QA 审查,包含完整性检查、自动关联 CAPA 生成和法规就绪关闭文档。
能力
专为生命科学法规要求和卓越运营而设计的全面能力。
Automated deviation initiation from any quality event — a pharmaceutical quality event management system covering batch records, lab incidents, complaints, and audits for complete batch deviation management
AI-powered classification as Critical / Major / Minor with risk scoring using GMP deviation investigation software capabilities
Configurable investigation workflows with root cause analysis tools including Ishikawa, 5-Why, and fault-tree — a full deviation investigation software suite
Deviation workflow automation with auto-linking to related CAPA, Change Control, and OOS/OOT records for full traceability
Impact assessment across products, batches, and processes with automated batch-hold triggers for pharmaceutical manufacturing deviations
Escalation engine with SLA-based reminders, automated deviation reporting software, and automatic notification to quality leadership
Trend dashboards showing deviation frequency by product line, site, and root cause category — a built-in deviation tracking system for enterprise-wide visibility
Cloud deviation management software with automated deviation reporting and nonconformance management system workflows for audit-ready compliance
实际应用
该模块在生命科学运营中提供可衡量价值的经验证场景。
在批次生产过程中自动采集偏差、评估批次影响、触发保留并追溯完整批次进行根本原因调查。
从监测系统检测环境偏差、分类严重性,并启动与关联环境数据的调查。
跟踪设备相关偏差、关联维护记录、评估产品影响并实施预防措施。
管理进货物料偏差、关联供应商资质认证记录,并触发供应商纠正措施请求。
常见问题
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