CAPA 관리
Drive closed-loop corrective and preventive actions from initiation through effectiveness verification — with AI-powered effectiveness intelligence that automatically compares new CAPAs against open effectiveness checks of similar nature, AI-assisted root cause analysis, automated task tracking, and audit-ready documentation.
40%
Faster CAPA Closure
100%
Source-to-Closure Tracing
AI
Effectiveness Intelligence
Zero
Missed Effectiveness Checks
엔드투엔드 프로세스 흐름
작동 방식
모든 단계에서 내장 규정 준수 체크포인트와 규제 방어력을 갖춘 개시부터 종결까지의 구조화된 워크플로우.
CAPA Initiation
Auto-initiate CAPA from deviations, complaints, audit findings, or OOS events with pre-linked source records and AI-powered duplicate detection against existing open CAPAs.
Root Cause Analysis
AI-assisted RCA with pattern matching from historical data, guided investigation tools, and evidence collection.
Action Planning
Build corrective and preventive action plans with task assignments, risk priority, due dates, and evidence requirements.
Implementation
Execute actions with milestone tracking, evidence capture, and automatic updates to linked quality records.
AI Effectiveness Intelligence
AI continuously monitors open effectiveness-check CAPAs and automatically compares every incoming CAPA of similar nature — flagging overlaps, recommending consolidation, and preventing redundant investigations.
Closure & Archive
Final approval with completeness validation, regulatory-ready documentation, and archival for inspection readiness.
기능
주요 기능
생명과학 규제 요구사항 및 운영 우수성을 위해 설계된 종합 기능.
Auto-initiation of CAPA from linked deviations, complaints, audit findings, and OOS events — a unified quality event CAPA management system
AI-powered root cause analysis software for pharma CAPA investigations, with pattern matching from historical CAPA data to prevent recurring deviations
CAPA workflow automation with configurable task assignments, due dates, risk priority, and evidence requirements — replacing manual CAPA tracking and spreadsheet-based CAPA management
Parallel corrective and preventive action tracking with separate owners, timelines, and CAPA documentation management for full regulatory defensibility
Built-in CAPA effectiveness check software with predefined success criteria, re-testing protocols, and automated CAPA closure and effectiveness tracking
AI-powered effectiveness intelligence — automatically compares every new CAPA against open effectiveness-check CAPAs of similar nature, flags potential duplicates, and recommends consolidation or cross-referencing to prevent redundant investigations
Extension management with documented justification, multi-level approval chains, and complete audit trail for GxP compliant CAPA processes
Real-time dashboards showing CAPA aging, overdue actions, CAPA effectiveness tracking, and recurring deviation management insights across all sites
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.
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
생명과학 분야의 최신 정보를 받아보세요
최신 제품 업데이트, 규정 준수 뉴스, 업계 인사이트를 받은 편지함으로 직접 받아보세요.