SMARTeAM – Simplifying GMP Equipment Compliance and Traceability
By Digital Flows SRL
SMARTeAM is a comprehensive Smartsheet Solution toolkit (sheets, reports and dashboards) designed to manage the full equipment lifecycle—commissioning, qualification, maintenance, calibration, and decommissioning—with full GMP audit-ready documentation.
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SMARTeAM streamlines GMP equipment management with validated, compliant digital workflows aligned with FDA 21 CFR Part 11 and EU Annex 11.
The solution emphasizes data integrity and traceability, two critical pillars of GMP compliance. It is ready to be validated in accordance with 21 CFR Part 11 and EudraLex Volume 4 guidelines, ensuring adherence to both US and EU regulatory requirements. Key benefits include: Compliance Assurance: Prevents use of non-qualified equipment and supports regulatory audits. Operational Efficiency: Simplifies scheduling and execution of maintenance and calibration tasks. Complete Traceability: Provides a transparent record of equipment status, qualification, and interventions. Lifecycle Management: Covers all stages from procurement to decommissioning. Ideal for QA/QC teams, manufacturing, maintenance, and calibration specialists, SMARTeAM delivers a reliable, scalable solution.
This dashboard provides a centralized view of your equipment fleet, offering key metrics on compliance, status, and departmental distribution. It serves as a hub to navigate to more detailed dashboards for specific equipment conditions. Integrated with Power BI, the dashboard delivers interactive charts and real-time insights, enabling users to filter data by compliance, status, or department. A dropdown list allows quick access to detailed information for individual equipment. By leveraging Smartsheet’s connectors, this solution integrates seamlessly with other tools and systems, automates workflows, and ensures data accuracy without duplication. The dashboard helps teams maintain compliance, prevent risks of malfunction, and reduce downtime—keeping your equipment fleet running efficiently.
The In Use Dashboard provides a clear, real-time view of all equipment currently in operation, along with their compliance status. This helps equipment users, QA teams, and management ensure that every piece of equipment is ready for production or analysis activities, minimizing downtime and maintaining quality standards. With this centralized view, teams can quickly identify risks, take corrective actions, and keep operations running smoothly.
This dashboard provides a centralized view of your equipment fleet, offering key metrics on compliance, status, and departmental distribution. It serves as a hub to navigate to more detailed dashboards for specific equipment conditions. Integrated with Power BI, the dashboard delivers interactive charts and real-time insights, enabling users to filter data by compliance, status, or department. A dropdown list allows quick access to detailed information for individual equipment. By leveraging Smartsheet’s connectors, this solution integrates seamlessly with other tools and systems, automates workflows, and ensures data accuracy without duplication. The dashboard helps teams maintain compliance, prevent risks of malfunction, and reduce downtime—keeping your equipment fleet running efficiently.
This dashboard centralizes all qualification activities—scheduled, ongoing, and completed—providing full visibility and control over the process. It ensures that performance and completion dates are tracked, along with qualification report references and conclusions. Using the Smartsheet Calendar App, upcoming qualification activities are displayed in a calendar view, allowing teams to monitor progress and update information directly. Smartsheet reports complement this by enabling easy updates and tracking of ongoing tasks. Once all qualification steps are completed, the equipment status automatically switches to In Use, ensuring compliance and readiness. Historical qualification data is available through a dedicated report for completed activities. Maintenance and calibration requests follow the same streamlined process, creating a unified approach to equipment lifecycle management.