AI Assistant

The AI Assistant provides intelligent automation across your quality management workflows. It generates content such as SOPs and investigation reports, offers real-time form field suggestions, validates compliance against regulatory standards, and recommends corrective and preventive actions.

What You Can Do

• Generate content — Create SOPs, reports, investigations, CAPA plans, and training materials with AI
• Get form suggestions — Receive AI-powered suggestions for form fields with confidence scoring
• Run compliance checks — Validate documents, processes, and workflows against regulatory standards
• Review CAPA recommendations — Get AI-generated corrective and preventive action recommendations
• Provide feedback — Accept, reject, or modify AI suggestions to improve future results

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AI-Generated Content

The AI Content module generates quality documents with built-in compliance validation.

Generating Content

1. Navigate to the AI Assistant page from the main menu.
2. Select the content type you want to generate:
   • Standard Operating Procedure (SOP)
   • Report
   • Investigation
   • CAPA Plan
   • Training Material
3. Provide source context or reference documents as prompted.
4. Click Generate to create the content.
5. Review the generated text along with the Quality Score (displayed as a percentage).

Reviewing and Editing Content

1. View the generated content in the preview panel.
2. Check the Quality Score — scores are color-coded:
   • Green (90%+): High quality
   • Yellow (70—89%): Acceptable quality
   • Red (below 70%): Needs improvement
3. Review the Regulatory Standards badges to see which standards were considered.
4. Click the Edit button to modify the generated text.
5. While editing, select a Review Status:
   • Pending
   • Approved
   • Rejected
   • Needs Revision
6. Add review notes to document your feedback.
7. Click Save Changes to update, or Cancel to discard edits.

Downloading Content

1. Click the Download button in the content header.
2. The content is saved as a plain text file named with the content ID.

Tip

Review the Compliance Check section at the bottom of each generated content item. It shows detailed validation results against applicable regulatory standards.

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Form Suggestions

The AI Form Suggestions feature provides intelligent auto-completion for form fields across the system.

Using Form Suggestions

1. Open any form that supports AI suggestions (deviations, CAPAs, documents).
2. Look for the magic wand icon near form fields.
3. Click the wand to generate suggestions for the current field context.
4. Review the suggestions panel that appears, showing:
   • Suggestion text
   • Confidence score (percentage)
   • Suggestion type (content, validation, completion, or optimization)

Applying Suggestions

1. Click Apply next to any individual suggestion to insert it into the field.
2. To apply all high-confidence suggestions at once, click the Auto-apply button (applies suggestions with 80%+ confidence).
3. Suggestions are sorted by confidence score, with the highest-confidence suggestions listed first.

Note

AI suggestions are generated based on the context of your current form data, including the title, description, root cause, and priority fields. The more information you provide, the better the suggestions.

Providing Feedback

1. After reviewing a suggestion, choose one of the feedback options:
   • Accept — The suggestion was helpful and accurate
   • Reject — The suggestion was not relevant
   • Modified — You used the suggestion but changed it
   • Ignore — You chose not to use or evaluate the suggestion
2. Optionally add feedback notes to explain your choice.
3. Click Copy to copy suggestion text to your clipboard.
4. Click Regenerate to request a new suggestion for the same context.

Tip

Your feedback improves the AI model over time. Consistently providing feedback helps the system generate more accurate suggestions for your organization.

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Compliance Checking

Automated compliance checks validate your documents, processes, and workflows against regulatory standards.

Running a Compliance Check

1. Navigate to the compliance check section of the AI Assistant.
2. Select or view an existing compliance check for an entity.
3. Review the check results:
   • Compliance Score — Overall compliance percentage
   • AI Confidence — How confident the AI is in its assessment
   • Compliance Status — Compliant, Non-Compliant, Under Review, or Pending

Understanding Findings

Findings are organized into three categories:

1. Critical Issues (red) — Serious compliance gaps that require immediate attention.
2. Minor Issues (yellow) — Non-critical findings that should be addressed.
3. Recommendations (green) — Suggested improvements to strengthen compliance.

If no issues are found, a “fully compliant” message is displayed.

Updating Compliance Status

1. Review the findings and validation details.
2. Add notes in the Status Notes field to document your assessment.
3. Click one of the status action buttons:
   • Mark Compliant — Entity meets all requirements
   • Mark Non-Compliant — Entity has unresolved compliance gaps
   • Under Review — Entity is being evaluated

Downloading a Compliance Report

1. Click the Download button in the check header.
2. A JSON report is generated containing the check ID, entity details, status, score, findings, and validation details.

Rechecking Compliance

1. Click the Refresh button to initiate a new compliance check.
2. The button animates while the recheck is in progress.
3. Results update automatically when the recheck completes.

Caution

Compliance checks are AI-assisted assessments and should be reviewed by qualified personnel before making regulatory decisions. Always verify critical findings manually.

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CAPA Recommendations

The AI generates comprehensive recommendations for Corrective and Preventive Actions across six categories.

Viewing Recommendations

1. Open a CAPA record to see AI-generated recommendations.
2. Recommendations are organized by category:
   • Corrective Action — Steps to address the immediate issue
   • Preventive Action — Measures to prevent recurrence
   • Verification — Methods to confirm the actions are effective
   • Effectiveness — Criteria for measuring long-term success
   • Timeline — Suggested implementation schedule
   • Resource — Required personnel, equipment, or budget
3. Use the category filter buttons to focus on specific recommendation types.

Evaluating Recommendations

Each recommendation includes:

• Priority — Importance level of the recommendation
• Confidence — AI confidence score for the recommendation
• Cost Impact — Estimated resource cost (when available)
• Impact Score — Expected positive impact on quality
• Timeline — Suggested implementation timeframe
• Resources — Required resources for implementation
• Success Metrics — How to measure successful implementation

Acting on Recommendations

1. Click Apply to accept and implement a recommendation.
2. Click Dismiss to remove a recommendation you do not plan to follow.
3. Click View Details to expand the full recommendation with all metadata.
4. The summary section at the top shows the total count of recommendations by category.

Note

CAPA recommendations consider historical data, industry best practices, and your organization’s quality patterns. Review them alongside your team’s domain expertise.

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Permissions

Action	Required Role
View AI-generated content	Any authenticated user
Generate new content	Any authenticated user
Edit and approve content	QA_Team, Admin
Run compliance checks	QA_Team, Admin
Apply CAPA recommendations	QA_Team, Admin

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Tips

Tip

Use the Quality Score as a quick indicator of content reliability. Scores above 90% typically require minimal editing, while scores below 70% may need significant revision.

Tip

When generating SOPs or investigation reports, provide as much source context as possible. The AI uses this context to produce more relevant and accurate content.

Tip

Download compliance reports regularly to maintain an audit trail of your compliance assessments. The JSON format makes it easy to integrate with other reporting tools.