Deviation Management Software
Manage quality and manufacturing deviations through a controlled digital workflow — from identification and recording through investigation, review, approval, and closure.
Business Challenge
Deviations spread across email, spreadsheets, and disconnected systems
Manufacturing and quality teams often struggle to record deviations consistently, assign investigations on time, and maintain traceability from initial event through closure.
AmpleLogic helps teams standardize deviation intake, classification, investigation, and approval within a single quality management workflow.
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。
Deviation Identified
Capture deviations from manufacturing, laboratory, or quality operations with linked context.
Record Deviation
Document the event with required fields, attachments, and responsible ownership.
Classification
Apply configurable classification criteria reviewed by authorized quality personnel.
Investigation
Conduct structured investigations with assigned tasks, evidence, and timelines.
Root Cause
Document root-cause analysis using supported investigation methods and reviewer input.
Action
Assign corrective actions with due dates, owners, and linkage to related quality records.
Review
Route records through quality review with completeness checks before approval.
Approval
Support multi-level approval workflows with electronic signatures where configured.
Closure
Close deviations with documented rationale, linked actions, and retained 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。
Deviation intake from quality and manufacturing events
Configurable classification and priority assignment
Investigation workflow with task assignment and due dates
Root-cause documentation with guided investigation support
Impact assessment across products, batches, and processes
Action tracking linked to CAPA and change control where applicable
Approval workflows with role-based review steps
Audit trail across record changes and approvals
Reporting and analytics for open and closed deviations
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
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爱尔兰（都柏林）
Block 1, Blanchardstown Corporate Park Ballycoolen Road, Dublin, D15 AKK1
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