20 unique prompts to enhance your quality systems
- Optimize Audit Readiness with AI
⭐ Use Case: Compare Internal Audit Findings with Regulatory Requirements
💻 Prompt:
Role: Act as a regulatory compliance expert in ISO 13485 and FDA 21 CFR Part 820.
Inputs: Provide internal audit findings and corresponding regulatory requirements.
Steps: 1) Match findings to specific regulatory clauses. 2) Highlight compliance gaps. 3) Suggest immediate corrective actions.
Expectations: Generate a prioritized action plan to close identified gaps.
- Automate Supplier Qualification
⭐ Use Case: Compare Supplier Documentation Against Qualification Criteria
💻 Prompt:
Role: Supplier Quality Manager
Inputs: Supplier documentation (certifications, process validations, audit results).
Steps: 1) Verify compliance with predefined qualification criteria. 2) Highlight missing or insufficient documentation. 3) Suggest additional actions based on criticality.
Expectations: Produce a checklist of approved and unapproved items with recommendations.
- Enhance Risk Management Processes
⭐ Use Case: Conduct a Failure Mode and Effects Analysis (FMEA)
💻 Prompt:
Role: Act as a quality risk management consultant.
Inputs: List potential failure modes and their severity, occurrence, and detection ratings.
Steps: 1) Calculate Risk Priority Numbers (RPNs). 2) Recommend mitigation actions for high-risk areas. 3) Provide updated risk scores post-mitigation.
Expectations: Deliver a completed FMEA table with actionable insights.
- Streamline Corrective Action Validation
⭐ Use Case: Assess CAPA Effectiveness
💻 Prompt:
Role: CAPA Specialist
Inputs: CAPA plan, implementation records, and outcome metrics.
Steps: 1) Verify CAPA implementation against the plan. 2) Evaluate effectiveness based on predefined metrics. 3) Identify residual risks.
Expectations: Create a summary report of CAPA validation findings and residual risks.
- Optimize Complaint Handling
⭐ Use Case: Review Customer Complaints for Trends
💻 Prompt:
Role: Post-Market Surveillance Analyst
Inputs: Complaint records over the last year.
Steps: 1) Categorize complaints by type and severity. 2) Identify recurring issues and root causes. 3) Recommend actions to address systemic problems.
Expectations: Provide a summary of trends, root causes, and corrective actions.
- Validate Process Changes
⭐ Use Case: Evaluate Change Control Impact
💻 Prompt:
Role: Change Control Specialist
Inputs: Proposed change control documentation and risk assessments.
Steps: 1) Assess the impact on current processes and products. 2) Verify compliance with regulatory requirements. 3) Recommend approval or rejection with justification.
Expectations: Deliver a comprehensive impact analysis report.
- Automate Document Review for Quality Manuals
⭐ Use Case: Compare Quality Manual to ISO 13485 Standards
💻 Prompt:
Role: Quality System Auditor
Inputs: Quality Manual and ISO 13485 requirements.
Steps: 1) Map Quality Manual sections to standard requirements. 2) Identify gaps or non-compliances. 3) Suggest updates to meet standards.
Expectations: Provide a gap analysis report with recommended revisions.
- Streamline Design Control Reviews
⭐ Use Case: Review Design History Files (DHF) for Completeness
💻 Prompt:
Role: Design Control Specialist
Inputs: Design History File documents.
Steps: 1) Check for completeness against FDA design control requirements. 2) Identify missing elements. 3) Propose corrective actions.
Expectations: Deliver a checklist of missing items and compliance status.
- Improve Training Effectiveness
⭐ Use Case: Review Training Records for Compliance
💻 Prompt:
Role: Training Records Auditor
Inputs: Employee training records and training program details.
Steps: 1) Verify training completion for all employees. 2) Identify gaps in competency or documentation. 3) Recommend remediation steps.
Expectations: Generate a training compliance summary report.
- Simplify Supplier Risk Assessment
⭐ Use Case: Evaluate Supplier Audit Scores and Risk Profiles
💻 Prompt:
Role: Supplier Risk Assessor
Inputs: Supplier audit scores, geographic data, and financial ratings.
Steps: 1) Assign risk levels to each supplier. 2) Identify suppliers requiring mitigation plans. 3) Recommend actions for high-risk suppliers.
Expectations: Deliver a supplier risk matrix with recommended actions.
- Optimize Complaint Trending Analysis
⭐ Use Case: Analyze Nonconformance Reports (NCRs)
💻 Prompt:
Role: Compliance Specialist
Inputs: NCR records.
Steps: 1) Categorize NCRs by root cause. 2) Trend analysis for recurrence. 3) Propose systemic corrective actions.
Expectations: Provide a detailed NCR trend analysis with actionable insights.
- Audit Cybersecurity Controls
⭐ Use Case: Verify Cybersecurity Compliance for SaMD
💻 Prompt:
Role: Cybersecurity Auditor
Inputs: Software specifications and security controls documentation.
Steps: 1) Assess compliance with cybersecurity standards. 2) Identify vulnerabilities. 3) Recommend mitigation strategies.
Expectations: Provide a cybersecurity compliance report.
- Accelerate Regulatory Submission Reviews
⭐ Use Case: Review 510(k) Submissions for Completeness
💻 Prompt:
Role: Regulatory Reviewer
Inputs: 510(k) submission documents.
Steps: 1) Verify all required sections are included. 2) Cross-check data against guidance documents. 3) Highlight any deficiencies.
Expectations: Deliver a checklist of compliant and non-compliant sections.
- Monitor Supplier Performance
⭐ Use Case: Develop a Supplier Scorecard
💻 Prompt:
Role: Supplier Performance Analyst
Inputs: On-time delivery, quality metrics, and audit scores.
Steps: 1) Calculate scores for each performance area. 2) Identify underperforming suppliers. 3) Recommend improvement plans.
Expectations: Provide a detailed supplier scorecard template.
- Evaluate Risk Management Files
⭐ Use Case: Assess Risk Management Documentation for ISO 14971 Compliance
💻 Prompt:
Role: Risk Management Specialist
Inputs: Risk management files.
Steps: 1) Check for compliance with ISO 14971 requirements. 2) Identify gaps in hazard analysis or risk controls. 3) Recommend updates.
Expectations: Deliver a compliance checklist with improvement suggestions.
- Simplify Clinical Evaluation Report Reviews
⭐ Use Case: Verify EU MDR Clinical Evidence Requirements
💻 Prompt:
Role: EU MDR Specialist
Inputs: Clinical Evaluation Reports and clinical study data.
Steps: 1) Assess evidence against EU MDR requirements. 2) Highlight deficiencies. 3) Recommend additional data collection.
Expectations: Provide a compliance assessment and action plan.
- Streamline Equipment Qualification
⭐ Use Case: Verify Equipment Qualification Documentation
💻 Prompt:
Role: Validation Engineer
Inputs: IQ, OQ, PQ documentation.
Steps: 1) Check for completeness and accuracy. 2) Identify gaps in testing. 3) Propose additional qualifications if necessary.
Expectations: Deliver a summary of qualification gaps and recommendations.
- Enhance Post-Market Surveillance
⭐ Use Case: Evaluate Post-Market Surveillance Reports
💻 Prompt:
Role: Post-Market Surveillance Expert
Inputs: PMS reports and regulatory requirements.
Steps: 1) Verify alignment with regulations. 2) Highlight data trends or compliance gaps. 3) Suggest corrective actions.
Expectations: Provide a PMS compliance report with action items.
- Audit Device History Records
⭐ Use Case: Compare DHRs to Device Master Records (DMRs)
💻 Prompt:
Role: Quality Inspector
Inputs: DHRs and DMRs.
Steps: 1) Cross-check for alignment. 2) Highlight inconsistencies or missing records. 3) Recommend corrections.
Expectations: Deliver a discrepancy report with prioritized actions.
- Analyze Process Validation Data
⭐ Use Case: Validate Process Validation Results Against Protocols
💻 Prompt:
Role: Validation Specialist
Inputs: Process validation results and original protocol.
Steps: 1) Verify adherence to protocol steps. 2) Identify deviations. 3) Recommend corrective actions for validation failures.
Expectations: Provide a detailed process validation review report.
Each prompt is crafted to save time and improve compliance outcomes using GenAI tools