How does Scilife handle version control for documents, and how do we ensure no one is using outdated versions?
Scilife uses automated version control to ensure that all documents are properly managed and updated. The system keeps track of all document versions, maintaining a clear history of versions with timestamps and user activity logs. Scilife ensures no one is using outdated versions by providing real-time access to only the latest approved and effective versions. Outdated versions are subsituted but remain accessible for audit purposes, ensuring compliance. Notifications are sent to inform users of updated documents.
Can Scilife integrate with our existing systems (e.g., ERP or LIMS) to centralize our documentation further?
Yes, Scilife supports integrations with external systems like ERP or LIMS . Using APIs and/or database, Scilife can synchronize data with your existing systems. This enables centralized documentation and seamless collaboration across platforms, reducing data silos and improving operational efficiency.
What happens if someone misses a document review or approval deadline?
If a deadline for document review or approval is missed, Scilife automatically sends notifications and reminders to the responsible users. The dashboard highlights overdue tasks, ensuring visibility. This process minimizes bottlenecks and ensures critical tasks are prioritized.
Can Scilife help us link identified risks to CAPAs to ensure proper follow-through?
Yes, Scilife allows you to link identified risks directly to CAPAs. This ensures traceability and accountability throughout the risk management process. You can create risk assessments, map them to CAPAs, and monitor progress in real-time. Scilife also provides tools to track CAPA effectiveness, helping to close the loop on risks effectively.
Does Scilife provide analytics or reports to monitor trends in deviations, NC’s or CAPAs across departments?
Scilife offers robust analytics and reporting features. You can obtain reports to track trends in deviations, non-conformities, or CAPAs across departments. The system provides dashboards and visualizations that help identify recurring issues, assess root causes, and evaluate the effectiveness of corrective actions. This helps improve decision-making and supports a culture of continuous improvement.
How does Scilife ensure visibility and accountability for tasks when multiple departments are involved?
Scilife provides a centralized platform with role-based access controls and task management to ensure visibility and accountability. Each task is assigned to specific users, with clear deadlines and responsibilities. Progress can be tracked in real-time via dashboards, and audit trails ensure transparency. Notifications and reminders ensure nothing is missed when multiple departments are involved.
How does Scilife help ensure regulatory compliance (e.g., FDA, EMA) while making processes more efficient?
Scilife is 21 CFR Part 11 compliant and aligned with GAMP5 for CSV. Scilife’s eQMS automates quality key processes, centralizes documented information to keep a single source of truth, avoiding silos of info. It provides tools for deviations management, training, audit management, change control, and offers analytics for continuous improvement. All electronic records are tracked securely ensuring data integrity.
