AI Assistant

The AI Assistant helps you draft SOPs, analyze documents for compliance gaps, and get instant answers about quality management topics through a conversational interface.

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Chat with the AI assistant

1. On the left sidebar, select AI Assistant.
2. Select the Chat tab.
3. In the text area at the bottom, type your question about quality management, deviations, CAPAs, compliance, or any EQMS topic.
4. Select Send or press Enter.
5. Review the assistant’s response in the chat window.
6. Continue the conversation as needed — the assistant retains context from the last several messages.

Tip

Ask natural-language questions such as “What is the correct procedure for handling a critical deviation?” or “Summarize the requirements for 21 CFR Part 11.”

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Generate quality content

Create a new document draft

1. On the left sidebar, select AI Assistant.
2. Select the Generate Content tab.
3. Under Content Type, select the type of document to generate:
   • Standard Operating Procedure
   • Deviation Report
   • CAPA Plan
   • Audit Checklist
   • Training Material
4. Optionally, enter a Title for the document.
5. In the Description / Context field, describe what you need. Include details about the process, department, or regulatory requirements.
6. Select Generate.
7. Review the generated content in the Generated Content card that appears below.

Copy generated content

1. After generating content, locate the Generated Content card.
2. Review the Quality percentage and Compliant / Review needed status shown in the card header.
3. Select Copy to Clipboard to copy the text for use in other documents or forms.

Tip

Provide as much context as possible in the description field. The AI uses this context to produce more relevant and accurate content.

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Analyze a document

Run a compliance, quality, or risk analysis

1. On the left sidebar, select AI Assistant.
2. Select the Analyze Document tab.
3. Under Analysis Type, select one of:
   • Compliance Check
   • Quality Review
   • Risk Assessment
4. In the Document Text field, paste the document content you want to analyze.
5. Select Analyze.
6. Review the Analysis Results card that appears, which includes:
   • A Risk level badge (High, Medium, or Low)
   • A Summary of the analysis
   • A list of Findings
   • A list of Recommendations

Caution

AI analysis results are machine-generated assessments. Always have qualified personnel review findings before making regulatory decisions.

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Use AI form suggestions

AI form suggestions are available on forms throughout the system (deviations, CAPAs, documents).

Apply a suggestion

1. Open any form that supports AI suggestions.
2. Look for the magic wand icon near form fields.
3. Select the wand to generate suggestions for the current field.
4. Review the suggestions panel showing each suggestion’s text, confidence score, and type.
5. Select Apply next to an individual suggestion to insert it into the field.
6. To apply all high-confidence suggestions at once, select Auto-apply (applies suggestions with 80%+ confidence).

Provide feedback on suggestions

1. After reviewing a suggestion, select 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 evaluate the suggestion
2. Optionally, add feedback notes to explain your choice.
3. Select Copy to copy the suggestion text to your clipboard.
4. Select Regenerate to request a new suggestion for the same context.

Tip

Consistently providing feedback improves the AI model over time, producing more accurate suggestions for your organization.

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Review and edit AI-generated content

When working with AI-generated content items (from the AIContent component):

Edit content and set review status

1. Select the Edit button (pencil icon) in the content card header.
2. Modify the generated text in the text area.
3. Select a Review Status from the dropdown:
   • Pending
   • Approved
   • Rejected
   • Needs Revision
4. Add review notes to document your feedback.
5. Select Save Changes to update, or Cancel to discard edits.

Download content

1. Select the Download button (download icon) in the content card header.
2. The content is saved as a plain text file named with the content ID.

Tip

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

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Permissions

Action	Required Role
View AI-generated content	Any authenticated user
Generate new content	Any authenticated user
Chat with AI assistant	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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Practical example: Using AI to generate SOP content for a new process

Scenario: A Process Engineer needs to draft an SOP for a newly validated lyophilization (freeze-drying) cycle for an injectable drug product. Instead of starting from a blank document, they use the AI Assistant to generate a first draft.

1. Navigate to AI Assistant and select the Generate Content tab.
2. Set Content Type to Standard Operating Procedure.
3. Enter the title: Lyophilization Cycle Operation and Monitoring.
4. In the Description / Context field, provide specific details:

   Generate an SOP for operating the SP Scientific LyoStar 3 freeze dryer for injectable vials. The cycle includes freezing at -45C for 4 hours, primary drying at -25C / 100 mTorr for 18 hours, and secondary drying at 30C / 50 mTorr for 6 hours. Include shelf temperature monitoring, chamber pressure checks, and moisture content verification per USP <921>. The SOP must address GMP requirements and include acceptance criteria for each phase.

5. Select Generate. The AI produces a structured SOP draft with sections for Purpose, Scope, Responsibilities, Equipment, Procedure (with numbered steps for each cycle phase), Acceptance Criteria, and References.
6. Review the Quality Score in the Generated Content card header — it shows 87% with a “Review needed” status, indicating the content is a strong starting point but requires expert review.
7. Select Copy to Clipboard and paste the content into an SOP document created from the “Standard Operating Procedure” template in the Templates module.
8. Now switch to the Analyze Document tab. Select Compliance Check as the analysis type and paste the generated SOP text.
9. Select Analyze. The results show:
   • Risk level: Medium
   • Finding: “No deviation handling procedure specified for out-of-range shelf temperature”
   • Recommendation: “Add a section describing actions when monitored parameters exceed acceptance criteria, including batch disposition decision tree”
10. Return to the SOP editor and add the missing deviation handling section based on the AI recommendation.
11. Submit the revised SOP for peer review by the Validation Manager and QA team.

The AI Assistant reduced the initial drafting effort from several hours to minutes, and the compliance analysis caught a gap that might otherwise have been identified only during formal review or, worse, during an audit.