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.
엔드투엔드 프로세스 흐름
작동 방식
모든 단계에서 내장 규정 준수 체크포인트와 규제 방어력을 갖춘 개시부터 종결까지의 구조화된 워크플로우.
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.
기능
주요 기능
생명과학 규제 요구사항 및 운영 우수성을 위해 설계된 종합 기능.
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
실제 적용
사용 사례
이 모듈이 생명과학 운영 전반에서 측정 가능한 가치를 제공하는 입증된 시나리오.
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.
자주 묻는 질문
자주 묻는 질문
우리의 글로벌 오피스
필요한 곳에 우리가 있습니다. 글로벌로 연결하고, 로컬로 전달합니다.
인도
Melange Tower, 2nd Floor, Wing-C, Patrika Nagar, HITEC City, Madhapur, Hyderabad - 500081, Telangana, India
아일랜드 (더블린)
Block 1, Blanchardstown Corporate Park Ballycoolen Road, Dublin, D15 AKK1
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