50 enhanced and innovative prompts tailored for leveraging GenAI in quality and compliance:
Supplier Management
- Supplier Qualification Assessment
⭐ Use Case: Ensure Suppliers Meet ISO 13485 Requirements
💻 Prompt:
Role: Supplier Quality Manager
Inputs: Supplier certifications, audit scores, and performance data.
Steps: Evaluate documentation, compare to ISO 13485 standards, and highlight deficiencies.
Expectations: Deliver a report with required corrective actions and approval status. - Supplier Risk Profile Analysis
⭐ Use Case: Develop a Comprehensive Risk Assessment
💻 Prompt:
Role: Risk Assessment Expert
Inputs: Supplier financial ratings, geographic data, and quality metrics.
Steps: Assign risk levels for each input and recommend mitigation strategies.
Expectations: Provide a risk matrix and actionable recommendations. - Supplier Audit Preparation
⭐ Use Case: Create a Pre-Audit Checklist
💻 Prompt:
Role: Audit Preparation Consultant
Inputs: Supplier type and regulatory requirements.
Steps: Generate a checklist tailored to the supplier type and regulatory focus.
Expectations: Provide a detailed checklist with instructions for each audit step. - Supplier Relationship Optimization
⭐ Use Case: Improve Communication and Performance
💻 Prompt:
Role: Relationship Management Advisor
Inputs: Supplier performance data and feedback.
Steps: Identify communication gaps and recommend improvement strategies.
Expectations: Deliver a supplier relationship action plan. - Track Supplier Performance Over Time
⭐ Use Case: Visualize Key Trends in Supplier Metrics
💻 Prompt:
Role: Data Analyst
Inputs: Historical performance data (e.g., delivery times, defect rates).
Steps: Identify trends, flag anomalies, and suggest improvements.
Expectations: Create a performance dashboard with visual insights.
Audit Readiness
- Mock Audit Simulation
⭐ Use Case: Identify Potential Gaps in Compliance
💻 Prompt:
Role: Mock Auditor
Inputs: Quality management system (QMS) documentation.
Steps: Simulate a regulatory audit and identify weaknesses.
Expectations: Provide a report of mock findings with remediation strategies. - Audit Response Review
⭐ Use Case: Evaluate Audit Response Letters
💻 Prompt:
Role: Audit Response Specialist
Inputs: Draft response letters and audit findings.
Steps: Assess tone, completeness, and accuracy of the response.
Expectations: Suggest edits to ensure regulatory approval. - Audit Finding Categorization
⭐ Use Case: Classify Audit Observations by Severity
💻 Prompt:
Role: Compliance Specialist
Inputs: Audit findings.
Steps: Assign severity levels to each finding and prioritize corrective actions.
Expectations: Deliver a categorized audit findings summary. - Generate On-the-Spot Audit Responses
⭐ Use Case: Provide Real-Time Answers During an Audit
💻 Prompt:
Role: Compliance Officer
Inputs: Questions from auditors and company documentation.
Steps: Craft clear, compliant responses based on the provided information.
Expectations: Deliver concise, regulatory-appropriate responses. - Post-Audit Improvement Plan
⭐ Use Case: Address Audit Weaknesses Systematically
💻 Prompt:
Role: Improvement Strategist
Inputs: Audit report and company resources.
Steps: Create a prioritized improvement roadmap with timelines.
Expectations: Provide a detailed action plan for closing gaps.
Risk Management
- Design a Risk Mitigation Plan
⭐ Use Case: Reduce High-Risk Areas in Processes
💻 Prompt:
Role: Risk Management Consultant
Inputs: Identified risks and current controls.
Steps: Propose additional controls and verify their effectiveness.
Expectations: Deliver a robust risk mitigation strategy. - FMEA Gap Analysis
⭐ Use Case: Evaluate Existing Failure Modes
💻 Prompt:
Role: Risk Specialist
Inputs: Existing FMEA records and process updates.
Steps: Identify outdated or missing failure modes and recommend updates.
Expectations: Deliver an updated FMEA table with recommendations. - Continuous Risk Monitoring Setup
⭐ Use Case: Automate Risk Identification
💻 Prompt:
Role: Risk Analyst
Inputs: Real-time process data and historical incidents.
Steps: Build a system for flagging risks as they arise.
Expectations: Deliver a risk dashboard with real-time alerts. - Regulatory Risk Trend Analysis
⭐ Use Case: Assess Industry-Wide Risks
💻 Prompt:
Role: Industry Analyst
Inputs: Recent warning letters and FDA 483 observations.
Steps: Identify common themes and suggest preventive measures.
Expectations: Provide a risk trends report with actionable insights. - Risk Assessment Automation
⭐ Use Case: Streamline Initial Risk Assessments
💻 Prompt:
Role: Automation Designer
Inputs: List of potential hazards and regulatory requirements.
Steps: Automate the risk scoring process based on inputs.
Expectations: Generate a complete risk assessment matrix.
Quality Management
- QMS Effectiveness Review
⭐ Use Case: Benchmark QMS Performance
💻 Prompt:
Role: QMS Auditor
Inputs: QMS metrics and industry standards.
Steps: Identify weak points in QMS processes and suggest improvements.
Expectations: Provide a QMS performance score and action items. - Complaint Handling System Review
⭐ Use Case: Evaluate Post-Market Processes
💻 Prompt:
Role: Complaint Analyst
Inputs: Complaint logs and resolution records.
Steps: Assess handling times, resolution effectiveness, and trends.
Expectations: Deliver a report with KPIs and recommendations. - Cross-Functional Process Mapping
⭐ Use Case: Visualize Quality Workflows
💻 Prompt:
Role: Process Designer
Inputs: Workflow descriptions and organizational structure.
Steps: Map processes to identify inefficiencies and overlaps.
Expectations: Provide a detailed workflow diagram. - Real-Time CAPA Tracking System
⭐ Use Case: Monitor Corrective Actions Progress
💻 Prompt:
Role: CAPA Tracker
Inputs: CAPA logs and deadlines.
Steps: Flag overdue actions and track completion rates.
Expectations: Deliver a live CAPA tracking dashboard. - Predictive Analytics for Quality Failures
⭐ Use Case: Forecast Defects Before They Occur
💻 Prompt:
Role: Data Scientist
Inputs: Historical defect data and process variables.
Steps: Build a predictive model for defect likelihood.
Expectations: Provide predictions and recommendations for prevention.
Regulatory Submissions
Regulatory Submissions
21. Accelerate EU MDR Technical Documentation
⭐ Use Case: Streamline the creation of technical documentation for EU MDR compliance
💻 Prompt:
Role: Regulatory Affairs Specialist
Inputs: Product specifications, existing technical files, EU MDR requirements
Steps: Analyze current documentation, identify gaps per MDR, update files accordingly
Expectations: Provide a complete MDR-compliant technical file ready for submission
22. Evaluate Clinical Study Reports for 510(k) Submissions
⭐ Use Case: Ensure Clinical Data Meets FDA Requirements for 510(k) Submission
💻 Prompt:
Role: Clinical Data Reviewer
Inputs: Clinical study reports, FDA 510(k) guidelines
Steps: Review clinical data for completeness and compliance, identify deficiencies, recommend amendments
Expectations: Deliver a report highlighting compliance status and suggesting improvements
23. Verify IFU Compliance for Global Markets
⭐ Use Case: Ensure Instructions for Use Meet Regulatory Standards Across Regions
💻 Prompt:
Role: Regulatory Compliance Analyst
Inputs: Current IFU documents, regional regulatory requirements
Steps: Compare IFU content with regulatory standards, identify discrepancies, recommend changes
Expectations: Provide a revised IFU compliant with all targeted global markets
24. Optimize De Novo Submissions for FDA
⭐ Use Case: Streamline De Novo Classification Requests
💻 Prompt:
Role: Regulatory Submission Strategist
Inputs: Device information, prior submissions, FDA De Novo guidelines
Steps: Analyze device novelty, prepare documentation, structure submission per FDA requirements
Expectations: Deliver a complete and optimized De Novo submission package
25. Compare Global Regulatory Pathways
⭐ Use Case: Determine the Most Efficient Regulatory Strategies for Multiple Markets
💻 Prompt:
Role: Global Regulatory Advisor
Inputs: Device type, target markets, regulatory requirements
Steps: Analyze pathways in each market, compare timelines and costs, recommend optimal strategies
Expectations: Provide a comparative report with recommended pathways for each market
Training and Competency
26. Create Competency Matrices for ISO Roles
⭐ Use Case: Define Required Competencies for Roles Under ISO Standards
💻 Prompt:
Role: Training and Development Coordinator
Inputs: Job descriptions, ISO competency requirements
Steps: Map required skills per role, identify gaps, create competency matrix
Expectations: Deliver a matrix aligning roles with ISO competencies
27. Review Employee Training Gaps Against SOPs
⭐ Use Case: Identify Training Deficiencies Related to SOPs
💻 Prompt:
Role: Training Compliance Auditor
Inputs: Employee training records, SOPs
Steps: Cross-reference training records with SOP requirements, identify gaps
Expectations: Provide a report highlighting training gaps and corrective actions
28. Automate Training Record Validation
⭐ Use Case: Ensure Training Records Are Up-to-Date and Compliant
💻 Prompt:
Role: Training System Analyst
Inputs: Digital training records, role-based training requirements
Steps: Develop a system to automatically validate records against requirements
Expectations: Deliver an automated validation tool with compliance status dashboard
29. Generate Role-Specific Training Plans
⭐ Use Case: Customize Training Programs for Individual Roles
💻 Prompt:
Role: Learning and Development Specialist
Inputs: Role descriptions, required competencies, available training modules
Steps: Match training modules to role requirements, create individualized plans
Expectations: Provide role-specific training plans outlining courses and timelines
30. Track Training Effectiveness with KPIs
⭐ Use Case: Measure the Impact of Training Programs
💻 Prompt:
Role: Performance Analyst
Inputs: Training completion data, employee performance metrics
Steps: Define KPIs for training effectiveness, analyze data, report findings
Expectations: Deliver a performance report showing training impact on KPIs
Cybersecurity in Medical Devices
31. Validate Cybersecurity Measures for SaMD
⭐ Use Case: Ensure Software as a Medical Device Meets Cybersecurity Standards
💻 Prompt:
Role: Cybersecurity Specialist
Inputs: SaMD architecture, cybersecurity guidelines (e.g., FDA, ISO 62304)
Steps: Assess current measures, identify vulnerabilities, recommend enhancements
Expectations: Provide a validation report with compliance status and strategies
32. Automate Threat Modeling for Connected Devices
⭐ Use Case: Identify Potential Cyber Threats Automatically
💻 Prompt:
Role: Security Analyst
Inputs: Device connectivity features, network diagrams
Steps: Use automated tools for threat modeling, identify risks, prioritize them
Expectations: Deliver a threat model report with countermeasures
33. Assess Compliance with ISO 27001
⭐ Use Case: Evaluate ISMS Against ISO 27001
💻 Prompt:
Role: Information Security Auditor
Inputs: ISMS documentation, ISO 27001 requirements
Steps: Compare ISMS with standards, identify non-conformities
Expectations: Provide an audit report with findings and recommendations
34. Perform Vulnerability Scans on IoMT Devices
⭐ Use Case: Detect Security Weaknesses in IoMT Devices
💻 Prompt:
Role: Penetration Tester
Inputs: Device specifications, network configurations
Steps: Conduct scans, analyze results, suggest remediation
Expectations: Deliver a vulnerability assessment with prioritized recommendations
35. Develop a Real-Time Cybersecurity Risk Dashboard
⭐ Use Case: Monitor Cybersecurity Risks Continuously
💻 Prompt:
Role: Cybersecurity Dashboard Developer
Inputs: Security logs, risk assessment data
Steps: Design a dashboard displaying real-time risks and alerts
Expectations: Provide an operational dashboard with risk visualization
Post-Market Surveillance
36. Create Adverse Event Reporting Templates
⭐ Use Case: Standardize Adverse Event Reporting
💻 Prompt:
Role: Post-Market Surveillance Coordinator
Inputs: Regulatory reporting requirements, previous reports
Steps: Design templates capturing all required information for each market
Expectations: Deliver standardized templates for global compliance
37. Trend Analysis for Device Failures
⭐ Use Case: Identify Patterns in Device Failures Over Time
💻 Prompt:
Role: Data Analyst
Inputs: Historical failure data, performance metrics
Steps: Analyze data to find trends, root causes, suggest preventive measures
Expectations: Provide a trend analysis report with actionable insights
38. Optimize Market Feedback Loops
⭐ Use Case: Enhance Feedback Mechanisms from Users
💻 Prompt:
Role: Customer Experience Analyst
Inputs: Customer feedback, service reports
Steps: Evaluate current processes, identify bottlenecks, propose improvements
Expectations: Deliver a plan to optimize feedback loops for quicker resolutions
39. Visualize Recall Data for Risk Mitigation
⭐ Use Case: Use Recall Data to Improve Future Products
💻 Prompt:
Role: Quality Improvement Specialist
Inputs: Recall records, root cause analyses
Steps: Visualize data to identify common issues, recommend design changes
Expectations: Provide visual reports and improvement recommendations
40. Automate PMS Report Creation for EU MDR
⭐ Use Case: Streamline Post-Market Surveillance Reporting
💻 Prompt:
Role: PMS Automation Engineer
Inputs: Surveillance data, EU MDR requirements
Steps: Develop an automated system to collect data and generate reports
Expectations: Deliver an automated tool compliant with EU MDR
Innovation and Future Trends
41. Leverage AI for Wearable Medical Device Data Insights
⭐ Use Case: Extract Valuable Insights from Wearable Device Data
💻 Prompt:
Role: AI Data Scientist
Inputs: Datasets from wearables, patient demographics
Steps: Apply AI algorithms to analyze data, identify patterns, correlate with outcomes
Expectations: Provide a report with insights and care improvement recommendations
42. Streamline 3D Printing Validation with AI Tools
⭐ Use Case: Optimize Validation Processes for 3D-Printed Devices
💻 Prompt:
Role: Validation Engineer
Inputs: 3D printing parameters, validation protocols
Steps: Use AI to predict optimal settings, validate device integrity
Expectations: Deliver a validation report with optimized parameters and compliance evidence
43. Develop Sustainability Metrics for QMS
⭐ Use Case: Incorporate Sustainability into Quality Management Systems
💻 Prompt:
Role: Sustainability Analyst
Inputs: QMS processes, environmental impact data
Steps: Define sustainability KPIs, integrate into QMS, monitor performance
Expectations: Provide metrics and an integration plan
44. Explore Blockchain for Supply Chain Transparency
⭐ Use Case: Enhance Traceability in the Supply Chain
💻 Prompt:
Role: Blockchain Specialist
Inputs: Supply chain data, blockchain platforms
Steps: Assess feasibility, design a blockchain solution, outline implementation
Expectations: Deliver a proposal for blockchain integration
45. Integrate Predictive Analytics in Process Control Systems
⭐ Use Case: Prevent Process Deviations Before They Occur
💻 Prompt:
Role: Process Control Analyst
Inputs: Historical process data, control parameters
Steps: Develop predictive models, integrate alerts into systems
Expectations: Provide a predictive analytics solution with real-time monitoring
Scorecards and Dashboards
46. Develop KPIs for Supplier Performance
⭐ Use Case: Measure and Monitor Supplier Performance
💻 Prompt:
Role: Supplier Performance Analyst
Inputs: Supplier data, business objectives
Steps: Define KPIs, design scorecards, set benchmarks
Expectations: Deliver KPIs with scorecards to track performance
47. Visualize NCR Trends Across Facilities
⭐ Use Case: Identify Non-Conformance Trends
💻 Prompt:
Role: Quality Data Analyst
Inputs: NCR data from facilities
Steps: Aggregate data, create visualizations to highlight trends
Expectations: Provide dashboards showing trends and areas of concern
48. Track Real-Time Process Deviations with AI
⭐ Use Case: Monitor Processes for Immediate Deviations
💻 Prompt:
Role: AI Monitoring Specialist
Inputs: Live process data, deviation thresholds
Steps: Implement AI models to detect anomalies, alert operators
Expectations: Deliver an AI-powered monitoring system with real-time alerts
49. Create Heat Maps for Audit Findings
⭐ Use Case: Visual Representation of Audit Findings Severity
💻 Prompt:
Role: Audit Data Visualizer
Inputs: Audit findings data, severity levels
Steps: Develop heat maps illustrating concentration and severity
Expectations: Provide heat maps to support decision-making
50. Build a Compliance Dashboard for Global Operations
⭐ Use Case: Centralize Compliance Status Across Regions
💻 Prompt:
Role: Compliance Dashboard Developer
Inputs: Compliance data, regulatory requirements
Steps: Design a dashboard aggregating data, displaying status by region
Expectations: Deliver a comprehensive dashboard for global monitoring
These prompts aim to maximize time-saving, enhance compliance, and support continuous improvement in quality and regulatory functions.
