Audit Management Software
Plan, execute, and close audits with structured checklists, findings management, action tracking, and audit history.
Business Challenge
Audit programs are difficult to coordinate without centralized records
Quality teams need consistent planning, execution, and follow-up across internal audits, supplier audits, and other audit types.
AmpleLogic supports audit planning through closure with linked findings, actions, and retained audit records.
端到端流程
审计管理工作流程：从计划到法规报告
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。
Audit Planning
Define audit scope, objectives, and schedule.
Scheduling
Assign auditors, sites, and timelines for planned audits.
Preparation
Prepare checklists, documents, and audit logistics.
Audit Execution
Record observations, evidence, and findings during the audit.
Findings
Classify findings and observations with required documentation.
Actions
Assign corrective actions and track responses to findings.
Review
Review audit outcomes and response adequacy.
Closure
Close audit records with complete history and linked actions.
能力
审计管理软件——符合21 CFR Part 11及EU Annex 11
专为生命科学法规要求和卓越运营而设计的全面能力。
Audit planning and scheduling
Auditor assignment and checklist management
Audit execution with findings and observations
Finding classification and action assignment
Audit response tracking and review
Support for internal and supplier audit workflows
Linkage to CAPA and deviation records
Audit history and trend reporting
Inspection readiness visibility for open findings
实际应用
制药、生物技术及医疗器械中的审计管理应用场景
该模块在生命科学运营中提供可衡量价值的经验证场景。
内部GMP审计
使用本制药质量体系审计管理软件安排并执行定期GMP审计——标准化检查表和自动化审计发现与CAPA集成工作流程。
供应商与经销商资质审计
通过供应商审计管理、经销商审计跟踪、资质评分、发现项跟踪和再资质排程，开展现场或桌面供应商质量审计。
法规检查准备
使用制药检查就绪软件仪表板识别差距、关闭待处理CAPA，并确保所有文件已为FDA、EU GMP或MHRA检查做好审计准备。
第三方与外部审计
通过内外部审计管理工作流程、文件共享、虚拟观察和电子证据收集，管理合同审计员的第三方审计管理。
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
审计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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