Quality Risk Management Software
Identify, assess, mitigate, and review quality risks with configurable scoring, action tracking, and documented risk history.
Business Challenge
Quality risks are hard to manage without structured assessment records
Teams need a consistent way to document risk identification, evaluation, mitigation actions, and residual risk review.
AmpleLogic supports configurable quality risk workflows without replacing expert risk judgment.
端到端流程
质量风险管理工作流程：AI驱动的识别到生命周期审查
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。
Risk Identification
Document identified quality risks with context and ownership.
Assessment
Record risk assessment inputs using configurable methodologies.
Risk Evaluation
Evaluate and classify risks reviewed by authorized personnel.
Mitigation Planning
Define risk controls and mitigation actions.
Action
Track mitigation actions with due dates and evidence.
Review
Review mitigation progress and control effectiveness.
Residual Risk Assessment
Document residual risk after mitigation activities.
Approval
Route risk records through required approval steps.
能力
QRM软件——符合21 CFR Part 11、EU Annex 11及ICH Q9
专为生命科学法规要求和卓越运营而设计的全面能力。
Risk identification and documentation
Configurable risk scoring and classification
Risk mitigation planning and action tracking
Residual risk review and approval
Risk history and reporting
Linkage to change control and CAPA
Role-based review and approval
Audit trail across risk records
Dashboards for open risks and actions
实际应用
制药、生物技术及医疗器械中的质量风险管理应用场景
该模块在生命科学运营中提供可衡量价值的经验证场景。
药品风险评估（FMEA、ICH Q9）
使用药品风险矩阵软件和FMEA风险分析软件，对新产品上市进行全面风险评估，涵盖工艺、分析、供应链和法规风险，并进行药品风险评分与优先排序。
生命科学根本原因与鱼骨图分析
使用鱼骨图分析软件、石川图风险分析、质量鱼骨分析软件、因果图分析、鱼骨图根本原因分析工具和五问法分析软件调查质量事件，以识别系统性根本原因。
AI驱动的企业风险分析与合规报告
在企业风险管理组合中利用风险分析与报告——风险评分系统仪表板、热图、RPN趋势和AI驱动风险管理软件洞察，用于制药质量风险管理。
GMP合规风险监控（21 CFR Part 11）
GMP风险监控系统和符合GMP的风险管理系统，实时跟踪产品、工艺和设施中的质量风险指标，具有自动升级和制药行业云风险管理软件部署能力。
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
质量风险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
引领生命科学前沿
获取最新产品更新、合规动态及行业洞察，直接发送至您的邮箱。