Product Recall Management Software
Initiate and manage product recalls with batch traceability, planning, execution tracking, effectiveness review, and documented closure.
Business Challenge
Recall events require rapid coordination and traceable records
When a quality issue may require product action, teams need structured recall assessment, batch identification, and coordinated execution tracking.
AmpleLogic supports recall workflows from assessment through effectiveness review without replacing quality decision-making.
端到端流程
产品召回工作流程：AI辅助启动到法规有效性
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。
Issue Identified
Document the triggering quality issue and initial assessment.
Recall Assessment
Evaluate recall scope, classification, and required actions.
Product/Batch Identification
Identify affected products, lots, and distribution context.
Recall Planning
Define recall plan, responsibilities, and communication steps.
Execution
Track recall execution activities and stakeholder coordination.
Tracking
Monitor recall status, responses, and reconciliation progress.
Effectiveness Review
Review recall effectiveness and document outcomes.
Closure
Close recall records with complete history and linked quality events.
能力
产品召回软件——符合FDA、EU及全球法规
专为生命科学法规要求和卓越运营而设计的全面能力。
Recall initiation and classification
Product and batch/lot traceability support
Recall planning and task coordination
Stakeholder communication tracking
Execution and status monitoring
Effectiveness review workflows
Linkage to complaints, deviations, and CAPA
Recall reporting and history
Audit trail across recall lifecycle
实际应用
制药、生物技术及医疗器械中的产品召回应用场景
该模块在生命科学运营中提供可衡量价值的经验证场景。
制药及生物技术产品质量缺陷召回
在规定时限内，通过批次特定可追溯性、客户通知和法规报告，执行产品质量缺陷召回。
受管制产品标签错误召回
通过影响评估、法规通知和分销渠道协调纠正，管理标签错误引起的召回。
I类安全相关召回（FDA及EU）
对安全关键问题执行I类召回，包括加急法规通知、紧急客户沟通和全面产品回收。
生命科学产品自愿撤市
通过结构化沟通、产品回收跟踪和监管透明度文件，管理自愿撤市。
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
产品召回管理软件常见问题解答
我们的 全球 办事处
我们在您需要的地方。全球联通，本地交付。
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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