Qualio’s AI Copilot helps you access and interact with your Qualio content across Documents, Events, and Compliance Intelligence. Rather than manually searching through your QMS, you can ask questions and get instant answers from your organization's documentation, create new drafts of documents or events, and gain insights into your compliance progress.
Note for enabling in Production instances: Because this feature is still in closed beta, it is not yet reflected in the current validation documentation. Please contact your CS Manager for more information about AI Copilot feature.
What Can the AI Copilot Do?
The AI Copilot supports a wide range of use cases across your QMS:
Documents
Answer questions from your controlled documents, draft new ones, and compare content across them.
"Which SOPs cover our supplier qualification process?"
"Draft an SOP for handling out-of-spec results, using our standard template."
Events
Log any event type with its step details in one conversation, and answer questions on trends and status.
"Log a complaint: cracked vial seal, lot 4471, received today. Assign the investigation to Dana, due in 5 days."
"How many deviations did we open last quarter, and what were the top causes?"
Training
See who's up to date, who's overdue, and prompt the people who need it.
"Who's overdue on training, and on what?"
“Send a reminder to everyone with outstanding training on the new quality policy.”
Suppliers
Review your supplier base by status and risk, and prepare for supplier audits.
"Which suppliers are overdue for review?"
"Pull together everything on Acme Plastics before Thursday's audit."
Design Controls
Surface traceability gaps across requirements and test cases, and build out your product record.
"Which requirements on the CardioSync product have no test cases?"
"Which test cases are failing or have outdated results?"
Compliance Intelligence
Track progress against your enabled frameworks, and understand what's blocking each control.
"Show me open high-severity gaps against ISO 13485."
“What's missing on control QMC-4 - no evidence, or evidence that's gone stale?”
This isn't a complete list, and it won't stay still. The Copilot's coverage across Qualio expands continuously. If it's something you'd do in Qualio, it's worth asking.
What Can the AI Copilot NOT do?
It's important to understand the difference between the AI Copilot and Qualio's support chat.
AI Copilot: Helps you understand and work with your own organization's content within Qualio. Use it to find information in your documents, create content, or understand your compliance status.
Support Chat: Connects you with Qualio support for help using the platform itself. Use it for questions about how to navigate Qualio features, troubleshoot issues, or learn about platform capabilities.
How is the AI Copilot Trained?
Customer data entered into Al prompts or generated outputs is not used to train Qualio's Al models.
Data Isolation & Non-Training Policy
Customer data remains isolated - All Al processing occurs within Qualio's AWS Bedrock environment and does not leave your AWS infrastructure.
No model training - The Al models are not trained on customer data and do not retain information after processing prompts.
Static models - The Al models are static and do not learn from user interactions.
Third-Party Provider Context
AWS Bedrock: Qualio uses AWS Bedrock (Claude and Titan models) within our own AWS environment.
Data doesn't leave Qualio's environment: Customer data sent to AWS Bedrock for analysis does not get sent back to Anthropic or any other third-party model provider.
Supplier qualification: Third-party providers are subject to Qualio's supplier qualification process to ensure compliance with data governance and security standards.
Note: Only the minimum data necessary is processed for Al functionality. Data is used solely for generating Al responses, not for any other purpose, and customers can enable or disable Al functionality for their accounts.
How to Enable the Copilot for your Instance
Check with your Customer Success Manager (CSM) to see if the Qualio Copilot is included in your package. Once the CSM enables the “Qualio Copilot” capability, admin users will be able to see this option under Admin Settings > Permissions.
Note: Once that is enabled in Admin Settings, you can proceed with the setup.
Accessing the AI Copilot
From the Side Navigation Menu
The AI Copilot is available from the left navigation bar. Click "AI Copilot" to open the chat interface on the right side of your view. This allows you to continue working while chatting with the Copilot.
How to Use the AI Copilot
Using the AI Copilot is as simple as having a conversation. Type your question or request in the chat field and press enter. The Copilot will provide a response based on your organization's Qualio content.
Asking Questions
You can ask the Copilot questions about your documentation, processes, or compliance status. For example:
"Do I have a procedure for logging customer complaints?"
"What are the steps for creating a CAPA?"
"How many open NCRs do we have?"
"What compliance gaps do we have in 21 CFR Part 11?"
“Summarize SOP-42 for me.”
“Which policy covers our customers' complaint handling?”
Creating and Editing Content
The AI Copilot can help you create new documents or events. When you ask the Copilot to draft content or create an event, it will show you a preview of what it will create before taking any action.
For document drafts: The Copilot displays proposed changes as redlines in the chat window. You can review the suggested content and approve or request modifications before any changes are made to your actual document.
For event creation: The Copilot can populate event details based on your description, including information across individual event steps. It creates a starting point that you can then complete with any additional required information.
Note: There is always a human-in-the-loop element to any actions taken by the Copilot. You maintain full control over what gets created or modified in your QMS.
Tips for better results
The more specific you are, the more specific the AI Copilot can answer your question.
Reference document names or IDs when you know them.
Ask focused, single-topic questions and create a new session when the topic changes.
If the first attempt does not directly find what you need, try rephrasing with different keywords.
Access and Permissions
The AI Copilot respects your existing Qualio permissions and access controls:
User role restrictions: The Copilot can only access the same features that you have permission to use. For example, if you don't have access to Compliance Intelligence, the Copilot cannot query compliance data on your behalf.
Document privacy: The Copilot respects private tags on documents. If a document has been tagged to restrict visibility to specific user groups, the Copilot will not include that content in responses for users who shouldn't have access.
Organization-wide availability: Once enabled, the AI Copilot is available to all users in your organization, but each user's experience is scoped to their individual permissions.
Conversation Sessions
Your conversation with the AI Copilot is accessible throughout your current session. You can scroll back through previous questions and answers to reference earlier parts of your discussion.
Note: Conversations are not currently stored for long-term access. When you end your session, the conversation history will not be available in future sessions.