SharePoint and Power Platform for Quality Management System (eQMS)

Your Microsoft Environment Fully Equipped for eQMS

SharePoint: Enterprise-Grade Infrastructure for Your Digital QMS

• Centralized Document Management
  SharePoint enables organizations to leverage an infrastructure they already know and trust. There is no need for a disruptive migration, teams can build workflows and automate processes step-by-step on top of their existing data. Used by thousands of businesses globally for storing and managing all types of documents, SharePoint is the perfect base for your eQMS.
• Collaboration with Security
  SharePoint provides an enterprise-grade level of security, access control, and reliability. Advanced permission management, real-time collaboration, and seamless integration with Microsoft apps allow teams to work on QMS content securely, with complete visibility on changes and communication.
• Long-Term Reliability
  With Microsoft’s ongoing support, backup strategies, and proven business continuity and disaster recovery measures, SharePoint offers unmatched reliability. Choosing SharePoint means partnering with a company whose infrastructure and commitment will remain dependable for years to come.

Ensuring Regulatory Compliance with SharePoint as Your eQMS

SharePoint Compliance Foundations

• Data Security & Access Control
  SharePoint leverages Microsoft 365 enterprise-grade security,including encryption at rest and in transit, multi-factor authentication, and role-based access control.
• Audit Trails & Version Control
  SharePoint tracks document changes, approvals, and user activity, enabling traceable audit trails critical for regulatory inspections.
• Data Retention & Records Management
  SharePoint’s information management policies allow organizations to define retention schedules, record types, and lifecycle rules supporting regulatory documentation requirements.
• Integration with Compliance Tools
  SharePoint works seamlessly with Microsoft Purview, Teams, and Power Platform to ensure comprehensive data governance and compliance monitoring.

Regulatory Standards Supported

• ISO 13485: Quality management systems for medical devices
• FDA 21 CFR Part 11: Electronic records and signatures for FDA-regulated industries
• EU MDR & IVDR: Medical Device and In Vitro Diagnostic Regulation requirements
• GxP (Good Practice) Standards: Including GMP, GLP, and GCP for life sciences industries
• HIPAA / GDPR: Data protection and privacy compliance for patient and sensitive data

How We Achieve Compliance

• Secure Configuration: Enforcing permissions, authentication, and encryption settings.
• Structured Document Management: Using libraries, metadata, and controlled versioning to manage SOPs, CAPAs, training records, and audit evidence.
• Automated Workflows: Power Automate ensures tasks such as approvals, notifications, and CAPA tracking follow pre-defined, auditable processes.
• Monitoring & Reporting: Power BI dashboards provide visibility into compliance metrics, overdue actions, and audit readiness.
• Governance Policies: Define roles, responsibilities, and standard operating procedures for system use.

Microsoft Power Platform: Extend and Elevate Your QMS

Power Apps: Custom Applications for QMS

Power Automate: Workflow Automation for Compliance

Power BI: Actionable Insights from Your QMS Data

A Connected Digital QMS Ecosystem

Power Apps Solutions: Tailored eQMS to Fit Your Business

Key Benefits of Power Apps for eQMS

• User-Friendly Interfaces – Build intuitive apps with modern UIs that simplify adoption across quality and compliance teams.
• Custom Workflows for Compliance – Support ISO 13485, FDA 21 CFR Part 11, EU MDR, and other regulations with workflows that reflect your exact processes.
• Adaptable & Future-Proof – Apps evolve with your business and regulatory requirements without the limitations of rigid off-the-shelf systems.

Strategic Benefits of Custom Power Apps in eQMS

• Accelerated Time-to-Value – Create and deploy fully functional QMS applications faster than traditional development, delivering business value sooner without compromising quality.
• Full Data Ownership & Security – All data stays within your Microsoft 365 environment, secured by Microsoft’s enterprise-grade standards.
• No Vendor Lock-In – If you ever move away from the solution, your apps and data remain yours, ensuring long-term flexibility and independence.

Power Apps Examples:

• Training Management App – Track employee certifications and send automated reminders for re-training.
• Audit & Inspection App – Collect audit findings, attach evidence, and sync results to SharePoint.
• Change Request App – Manage and track the lifecycle of change requests with automated approvals and full traceability.
• Deviation & CAPA Tracking App – Record deviations, escalate CAPAs, and monitor resolution status in real time.

Power Automate: Compliance-Driven Digitalization Customized to You

What our Automation Delivers:

• Event- and schedule-based triggers for actions and reminders
• Fully traceable, audit-ready process execution
• Streamlined document and task management across teams
• Real-time monitoring of deadlines and CAPA status
• Reduced manual effort and human error

Typical Automations in QMS and Operations:

• Automated Document Approval – Route SOPs or work instructions for review and approval with digital signatures.
• CAPA Escalation Alerts – Send automated reminders or escalation notices when CAPA deadlines are approaching or missed.
• Supplier Qualification – Automatically collect supplier responses, store documentation in SharePoint, and notify quality managers when action is required.
• Audit Preparation Workflows – Generate audit checklists, notify stakeholders, and compile evidence automatically.

Power BI: Turning QMS Data Into Intelligence

Examples in QMS and Operations:

• CAPA Effectiveness Dashboard – Track CAPA closures, overdue items, and long-term effectiveness metrics.
• Training Compliance Reports – Visualize training completion rates, upcoming expirations, and competency gaps across teams.
• Supplier Performance Dashboard – Monitor supplier quality, on-time delivery, and audit results.
• Regulatory Audit Readiness Dashboard – Compile key compliance indicators to demonstrate readiness for FDA, ISO, or notified body inspections.

For Larger Organizations

• Scalability: Power Platform is ideal for larger organizations that need scalable solutions to manage complex workflows, large amounts of data, and multiple teams. Manage complex, global workflows across multiple sites.
• Support for Distributed Teams: Whether your employees are in different locations or departments, SharePoint and Power Platform enable smooth collaboration across teams, ensuring consistency and productivity.
• Cost-Effective: With the ability to build custom solutions and automate processes, large companies can significantly reduce overhead costs and improve operational efficiency.

How SharePoint & Power Platform Work Together to Improve Your QMS

The Layers of the Microsoft Quality Ecosystem

• SharePoint as the Backbone
  SharePoint serves as the secure repository and collaboration hub, it centralizes documents, lists, and records while enforcing permissions, version control, and compliance rules.
• Power Apps as the User Experience Layer
  Instead of relying on SharePoint’s native forms, Power Apps provides flexible, mobile-ready interfaces. This makes complex quality processes intuitive for end users while still writing data directly back to SharePoint.
• Power Automate as the Connective Tissue
  Power Automate keeps processes in motion. Actions in SharePoint or Power Apps can trigger workflows that route approvals, send notifications, synchronize data, or connect with external systems.
• Power BI as the intelligence layer
  Once processes are running and data is flowing; Power BI turns it into actionable insights. Reports and dashboards can be embedded directly in SharePoint, providing managers with oversight and compliance monitoring in real time.

Practical QMS Interactions Across Platforms

• SharePoint + Power Automate
  An item is added to a SharePoint list (e.g., a new deviation record), and Power Automate automatically starts a workflow, routing it for approval, sending reminders, and logging every step for audit purposes.
• SharePoint + Power Apps
  Power Apps provides user-friendly forms and interfaces on top of SharePoint lists and libraries. For example, employees can log incidents via a mobile app, with all data securely stored in SharePoint for version control and compliance.
• SharePoint + Power BI
  Power BI dashboards can be embedded directly into SharePoint pages, allowing managers to track CAPA status, training compliance, or supplier performance in real time, all without leaving their QMS portal.
• Full Integration Across the Platform
  A change request entered in Power Apps is stored in SharePoint, routed through Power Automate for approvals, and visualized in Power BI dashboards. Every component works together, delivering a seamless, traceable QMS process.

Examples of QMS Software Solutions with SharePoint and Power Apps

• Incident Management – Track and resolve incidents such as quality deviations or workplace accidents.
• Approval Workflows – Automate approvals for documents, CAPAs, product designs, or change requests.
• KPI Monitoring Dashboards – Visualize real-time KPIs across departments to monitor compliance and efficiency.
• Change Control Management – Document, approve, and implement changes with full traceability.
• Document Review & Approval – Streamline document lifecycle management, from drafting to version control and regulatory submission.
• Internal Audit Tracker – Plan, execute, and monitor audits, including findings and corrective actions.
• Supplier Management – Track supplier qualifications, performance, and compliance requirements.
• Training & Competency Management – Ensure training records are current, certifications are valid, and managers are alerted to expirations.
• Customer Complaint Handling – Capture, investigate, and resolve complaints while documenting corrective actions.
• Equipment Calibration & Maintenance Logs – Schedule, track, and document calibration/maintenance for regulatory compliance.

Advantages of Using SharePoint & Power Platform for Quality Management

• Full Control by Your Organization
  With SharePoint and Power Platform, you retain full control over your applications and data. Data stays within your Microsoft 365 environment; no vendor lock-in.
• Modular & Scalable
  Build small, tailored solutions for each area of your QMS. Whether it’s project management, HR, or sales, you can customize the platform to meet your specific needs and expand as your QMS matures.
• Seamless Integration
  If your company already uses Microsoft products, the integration is seamless and cost-effective. These tools work with your existing Microsoft ecosystem, including Teams, Outlook, Excel, and other Microsoft 365 tools.
• Enterprise-Grade Security
  Powered by Microsoft’s robust security infrastructure, all your data is protected by enterprise-grade security. Authentication is managed through Microsoft, so your team can log in using the same credentials they use for Outlook and other Microsoft services.
• Minimal Disruption
  Incremental adoption ensures a smooth transition without interrupting critical QMS activities. There’s no need for a big bang solution; customize at your own pace, and scale as you grow.
• Cost-Effective Implementation
  Unlike specialized QMS software with high recurring license fees, SharePoint and Power Platform rely on your existing Microsoft 365 subscription. In most cases, the tools are already available in your organization, making digital QMS adoption faster and more budget-friendly.

Extending Beyond Power Platform

• Using External Connectors & APIs – Integrating with third-party systems like ERP, CRM, or MES.
• Leveraging the SharePoint Framework (SPFx) – Creating custom components and user experiences within SharePoint.
• Utilizing Microsoft Graph API – Enabling secure, scalable integrations across Microsoft 365 services.

Advanced Integrations for SharePoint & Power Platform

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