60%
Cycle Time Reduction
100%
Audit Trail Coverage
Zero
Uncontrolled Changes
Auto
SOP & Training Updates
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 configurable forms for process, equipment, material, or regulatory change types.
Impact Assessment
Multi-department impact analysis covering quality, regulatory, production, validation, and supply chain considerations.
Risk Classification
Risk-based classification (Minor, Major, Critical) with automated approval routing based on change severity.
Approval Routing
Multi-stakeholder approval workflow with electronic signatures, comments, and conditional routing logic.
Implementation
Task tracking with milestone-based progress monitoring, evidence capture, and auto-trigger of SOP revisions and training.
Effectiveness Review
Post-implementation review with predefined KPIs, success metrics, and documented evidence of change effectiveness.
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 with configurable forms for different change types (process, equipment, material, regulatory)
Multi-department impact assessment covering quality, regulatory, production, validation, and supply chain
Risk-based classification (Minor, Major, Critical) with automated approval routing
AI-powered change impact prediction based on historical change data and deviation patterns
Implementation task tracking with milestone-based progress monitoring and evidence capture
Post-implementation effectiveness review with predefined KPIs and success metrics
Auto-trigger of DMS SOP revisions and LMS training assignments on change approval
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.
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。