CAPA Management Software
Drive corrective and preventive actions from quality issues through investigation, implementation, effectiveness verification, and closure.
Business Challenge
CAPA programs lose momentum without structured follow-through
Corrective and preventive actions often stall when assignments, evidence, and effectiveness checks are tracked outside the quality system.
AmpleLogic supports closed-loop CAPA management with defined workflows from initiation through effectiveness verification and approval.
端到端流程
工作原理
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 Issue
Initiate CAPA from deviations, complaints, audits, OOS/OOT, or other quality events.
Investigation
Document investigation findings, contributing factors, and supporting evidence.
Root Cause
Record root-cause analysis outcomes reviewed by authorized personnel.
Corrective/Preventive Action
Define corrective and preventive actions with owners and due dates.
Assignment
Assign implementation tasks across functions with accountability and timelines.
Implementation
Track action completion with evidence and status updates.
Effectiveness Check
Verify whether actions addressed the issue through documented effectiveness review.
Approval
Route CAPA for quality approval after implementation and effectiveness review.
Closure
Close CAPA with retained history, linked source events, and audit trail.
能力
核心功能
专为生命科学法规要求和卓越运营而设计的全面能力。
CAPA creation from linked quality events
Root-cause investigation documentation
Corrective and preventive action planning
Task assignment with due dates and escalations
Effectiveness check workflows separate from action closure
Multi-level review and approval
Linkage to deviations, complaints, audits, and OOS/OOT
CAPA aging and status reporting
Audit-ready CAPA history and documentation
实际应用
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。
Recurring Deviation Pattern
Identify recurring deviations, group them into a systemic CAPA, conduct comprehensive root cause analysis, and implement preventive measures.
Audit Finding Remediation
Convert critical and major audit findings into tracked CAPAs with defined timelines, responsible parties, and effectiveness verification.
AI-Driven Effectiveness Overlap Detection
When a new CAPA is created, AI automatically scans all open effectiveness-check CAPAs of similar nature — flagging potential duplicates, recommending cross-references, and surfacing existing corrective actions that may already address the same root cause.
Regulatory Inspection Response
Rapidly create and track CAPAs in response to regulatory observations with documented evidence and timeline compliance.
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
常见问题解答
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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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