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.
エンドツーエンドのプロセスフロー
仕組み
開始からクローズまでの体系的なワークフロー。すべての段階に組み込まれたコンプライアンスチェックポイントと規制上の正当性を備えています。
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.
機能・能力
主要機能
ライフサイエンスの規制要件と業務卓越性のために設計された包括的な機能。
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
実際の活用事例
ユースケース
ライフサイエンスオペレーション全体で測定可能な価値を提供するモジュールの実証済みシナリオ。
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.
よくある質問
よくある質問
私たちの グローバル オフィス
必要な場所に、私たちがいます。グローバルにつながる、ローカルに届ける。
インド
Melange Tower, 2nd Floor, Wing-C, Patrika Nagar, HITEC City, Madhapur, Hyderabad - 500081, Telangana, India
カナダ（ノースヨーク、トロント）
5255 Yonge Street Suite 201, North York, ON, M2N 6P4
アイルランド（ダブリン）
Block 1, Blanchardstown Corporate Park Ballycoolen Road, Dublin, D15 AKK1
シンガポール
1 Scotts Road, #24-10 Shaw Centre, Singapore, Singapore, 228208
ライフサイエンスの最前線へ
最新の製品アップデート、コンプライアンスニュース、業界インサイトをお届けします。