Change Control Software
Manage planned and unplanned changes with structured impact assessment, review, approval, implementation, and verification.
Business Challenge
Uncontrolled changes create quality and compliance risk
Changes to processes, equipment, materials, or systems need documented assessment, stakeholder review, and traceable implementation.
AmpleLogic helps teams manage change requests through configurable workflows from initiation to verification and closure.
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。
Change Request
Initiate change requests with classification and supporting documentation.
Classification
Categorize changes using configurable criteria reviewed by quality teams.
Impact/Risk Assessment
Document impact and risk considerations across affected areas.
Review
Route changes to stakeholders for structured review and input.
Approval
Obtain required approvals before implementation begins.
Implementation
Track implementation tasks, milestones, and evidence.
Verification
Verify that the change was implemented as approved.
Closure
Close the change record with retained history and linked actions.
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。
Change request initiation and classification
Impact and risk assessment documentation
Multi-stakeholder review and approval routing
Implementation planning and task tracking
Post-implementation verification workflows
Change history and traceability
Linkage to CAPA, deviations, and training where applicable
Configurable forms for different change types
Reporting on open and overdue changes
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。
Manufacturing Process Change
Manage changes to manufacturing parameters, assess impact on product quality, update SOPs, and retrain operators with tracked timelines.
Equipment Replacement
Control equipment changes from qualification through validation, with linked IQ/OQ/PQ protocols and impact on existing product registrations.
Regulatory-Driven Change
Implement changes required by new regulations, track multi-site rollout, and ensure all affected processes are updated and validated.
Raw Material Supplier Change
Manage supplier changes with qualification requirements, stability testing, and regulatory notification workflows.
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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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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