Electronic Deviation Management
Manage deviations within an electronic quality management system — centralized records, electronic workflows, linked quality events, and audit-ready review and approval.
Business Challenge
Paper and fragmented tools limit electronic quality-event control
Electronic quality management depends on centralized deviation records, controlled workflows, and traceable linkage to CAPA, change control, and related quality processes.
AmpleLogic eQMS helps teams manage deviations as part of a broader electronic quality workflow rather than isolated spreadsheets or email threads.
端到端流程
偏差管理工作流：AI 驱动从发起到 GMP 关闭
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。
Quality Event Identified
Capture deviations within the eQMS with linked manufacturing or laboratory context.
Electronic Record Creation
Create centralized deviation records with required metadata and attachments.
Workflow Routing
Route deviations through configurable electronic review and approval steps.
Investigation
Conduct investigations with assigned tasks, evidence, and electronic signatures where configured.
Impact Assessment
Document impact across products, batches, and linked quality events.
CAPA / Change Linkage
Link deviations to CAPA, change control, and related records where applicable.
Quality Review
Complete structured QA review with audit trail visibility.
Approval & Closure
Approve and close deviations with retained electronic history.
能力
偏差管理软件能力——符合 21 CFR Part 11
专为生命科学法规要求和卓越运营而设计的全面能力。
Centralized electronic deviation records
Configurable electronic workflows and approvals
Quality-event tracking across the eQMS
Investigation and root-cause documentation
Linkage to CAPA and change control
Electronic signatures and audit trails
Role-based access across quality functions
Quality dashboards for open deviations
Reporting across sites and product lines
实际应用
制药、生物技术与生命科学中的偏差管理使用案例
该模块在生命科学运营中提供可衡量价值的经验证场景。
制药生产批次偏差跟踪
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。
生物技术与制药环境监测偏差
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。
设备故障偏差调查
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。
原材料不合格品调查与供应商 CAPA
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。
GxP & Data Integrity
Designed to support regulated quality operations
AmpleLogic provides controls that help support regulated quality processes. These capabilities alone do not guarantee regulatory compliance.
Audit Trails
Track relevant changes and activities across records, reviews, and approvals.
Electronic Signatures
Support controlled review and approval workflows with documented sign-off.
Role-Based Access
Provide access according to user responsibilities across quality processes.
Traceability
Maintain visibility across records, linked quality events, actions, and approvals.
Controlled Workflows
Standardize quality processes with configurable workflow steps and checkpoints.
Version Control
Maintain controlled versions of relevant records, forms, and supporting information.
常见问题
偏差管理软件常见问题
我们的 全球 办事处
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