OOS Management Software
Manage Out-of-Specification investigations with structured laboratory and manufacturing review, action tracking, and quality approval.
Business Challenge
OOS investigations require disciplined, traceable workflows
Laboratory and manufacturing teams need consistent processes to investigate OOS results, document findings, and route records for quality review.
AmpleLogic supports OOS investigation workflows from initiation through closure with linked actions and audit history.
端到端流程
OOS调查工作流程：符合FDA的检测到处置
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。
OOS Result
Record OOS events with test, batch, and specification context.
Investigation
Initiate structured OOS investigations with assigned responsibilities.
Laboratory Assessment
Document laboratory-phase review, testing, and findings.
Manufacturing/Process Review
Extend investigation to manufacturing or process factors where applicable.
Root Cause
Document root-cause conclusions reviewed by authorized personnel.
Action
Assign corrective actions with tracking and due dates.
Quality Review
Route investigations through quality review and approval.
Closure
Close OOS records with complete investigation history.
能力
OOS管理软件——符合21 CFR Part 11及GLP
专为生命科学法规要求和卓越运营而设计的全面能力。
OOS event recording and investigation initiation
Laboratory investigation workflows
Manufacturing or process review support
Root-cause documentation and action tracking
Quality review and approval routing
Linkage to deviations, CAPA, and complaints
Investigation history and status reporting
Due-date management and escalations
Audit trail across OOS lifecycle
实际应用
制药及生物技术QC实验室中的OOS调查应用场景
该模块在生命科学运营中提供可衡量价值的经验证场景。
成品放行检测
使用本实验室偏差调查系统对批次放行检测中的OOS结果进行调查，确定根本原因，并做出有科学依据的批次处置决策。
稳定性研究失败
通过FDA合规OOS管理，管理稳定性研究中的超标调查结果，评估对有效期、法规申报和已上市产品的影响。
原料检测
使用GxP实验室调查软件对进料的OOS结果进行调查，与供应商协调，并评估对计划生产批次的影响。
过程控制失败
在本GMP OOS调查软件中，利用实时批次影响评估、工艺暂停决策和根本原因调查处理过程中的OOS结果。
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
OOS调查软件常见问题解答
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印度
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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