Laboratory Incident Management Software
Record, investigate, and close laboratory incidents with sample impact assessment, action tracking, and audit-ready documentation.
Business Challenge
Laboratory incidents need fast recording and controlled follow-up
Equipment issues, sample handling problems, testing interruptions, and procedural incidents can affect data integrity and sample disposition.
AmpleLogic helps laboratory teams document incidents, assess impact, and manage investigations through closure.
端到端流程
实验室事件工作流程：AI辅助记录到GMP预防
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。
Incident Recording
Capture laboratory incidents with required details and ownership.
Classification
Classify incidents using configurable laboratory criteria.
Investigation
Assign investigation tasks with evidence and timelines.
Sample/Test Impact
Assess impact on samples, tests, and associated results.
Root Cause
Document root-cause analysis reviewed by authorized personnel.
Action Tracking
Assign corrective actions with due dates and status updates.
Review
Route incidents through quality or laboratory review.
Closure
Close incidents with retained history and audit trail.
能力
实验室事件软件——符合21 CFR Part 11及EU Annex 11
专为生命科学法规要求和卓越运营而设计的全面能力。
Laboratory incident recording and classification
Investigation workflow with task assignment
Sample and test impact assessment
Root-cause documentation support
Action tracking and escalation
Review and approval workflows
Laboratory trend and incident reporting
Linkage to deviations, OOS, and CAPA
Audit trail across incident lifecycle
实际应用
制药及生物技术QC实验室中的实验室事件应用场景
该模块在生命科学运营中提供可衡量价值的经验证场景。
GLP/GMP实验室仪器故障调查
使用本实验室事件报告软件记录仪器故障，评估对待处理和已完成检测的影响，与维护团队协调，并管理重新检测要求。
生物技术样品污染与完整性调查
使用本实验室事件管理系统调查样品污染或混淆事件，确定影响范围，并管理重新取样和重新检测工作流程。
制药及生物技术洁净室环境偏差
在本GxP合规实验室事件报告系统中采集环境监测偏差，评估对受影响区域样品和产品的影响，并触发纠正措施。
试剂与对照标准品失败调查
通过本GMP实验室事件管理平台，管理涉及过期、污染或制备不当的试剂和对照标准品的事件，评估对检测结果的影响。
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
实验室事件管理软件常见问题解答
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Melange Tower, 2nd Floor, Wing-C, Patrika Nagar, HITEC City, Madhapur, Hyderabad - 500081, Telangana, India
爱尔兰（都柏林）
Block 1, Blanchardstown Corporate Park Ballycoolen Road, Dublin, D15 AKK1
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