AI Assistant

The AI Assistant helps you draft SOPs and get instant answers about quality management topics through a conversational interface. To analyse an existing document, use the AI Compliance Officer on Regulatory Checks.

---

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.

Note

The assistant answers questions about quality management and about using the EQMS. A message about anything else — the weather, a recipe, a poem, general chat — is declined with a short notice instead of an answer. The Generate tab applies the same rule to its prompt.

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.”

---

Generate quality content

Create a new document draft

1. On the left sidebar, select AI Assistant.
2. Select the Generate 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 Draft badge in the card header. It shows the draft’s completeness — for example Draft · completeness 87%, or Draft · needs work 25% when the figure is below 70%. The figure is a heuristic on the text (whether the expected topics — purpose, procedure, roles, references, records, review — are mentioned); it is not a compliance assessment. Compliance is established when the document is reviewed and approved.
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.

---

Analyze a document

Document analysis has moved to the AI Compliance Officer on the Regulatory Checks page. It no longer works on pasted text: you pick a document from your register, and the result is saved to that document so you can read it again later.

See Analyse a document for the steps.

---

AI suggestions on other forms

Two forms outside the AI Assistant page offer their own, purpose-built AI suggestions — not a generic feature available everywhere:

• Deviations: reporting a new deviation shows a Suggested Severity Classification and up to three Similar Historical Deviations as you type the title and description. See Reporting Deviations — Review AI suggestions.
• CAPA: the CAPA detail page can suggest corrective/preventive actions for a CAPA record. See the CAPA module documentation.

Neither surface uses a magic-wand icon, a per-suggestion confidence score, or Accept/Reject/Modified/Ignore feedback buttons — those describe an earlier, unshipped design and have been removed from this page. Suggestions are recommendations only; you always have final control over what’s saved.

---

Usage limits

AI features (Chat, Generate, document analysis, and the AI suggestions on other forms) draw against two limits:

• Your organization’s monthly plan allowance. Compliance and Growth plans have a monthly token allowance; Enterprise is unlimited.
• A platform-wide daily and monthly ceiling, independent of plan, that protects the service for everyone.

If either limit is reached, the request is declined with a clear message asking you to try again later or contact your administrator — it never fails silently or returns an empty answer. Your organization’s Admin can review usage on Admin → Monitoring → AI Usage (Enterprise plan).

---

Permissions

Action	Required Role
Generate new content	Any authenticated user
Chat with AI assistant	Any authenticated user
Analyse a document (on Regulatory Checks)	QA_Team, Admin — needs compliance.regulatory_review
Review deviation severity/similarity suggestions	Any authenticated user who can report a deviation
Apply CAPA recommendations	QA_Team, Admin

---

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 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 Draft badge in the Generated Content card header — it shows Draft · completeness 87%, indicating the content is a strong starting point that still requires expert review before it can be approved.
7. Select Copy to Clipboard and paste the content into an SOP document created from the “Standard Operating Procedure” template in the Templates module, then save it as a document in the register.
8. Go to Regulatory Checks and pick the new SOP document, then select Compliance Check as the analysis type (see Analyse a document).
9. Run the analysis. The results show, for example:
   • 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 document 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.