The Change Controls module centralizes the evaluation and implementation of changes across processes, products, or systems. By integrating risk assessments, regulatory requirements, and tracking workflows, it ensures that modifications are executed efficiently while maintaining compliance.
Standardized Workflows: Define clear steps for evaluating, approving, and implementing changes.
Risk and Impact Assessment: Identify potential effects on quality, timelines, and compliance before rollout.
Documentation and Traceability: Maintain a transparent record of decisions, justifications, and approvals.
Notifications and Alerts: Keep stakeholders informed of pending tasks, approvals, and deadlines.
Cross-Module Integration: Connect with CAPA, Document Control, and other QMS components for cohesive change management.