engamp® | intelligence
AI in Quality Management
– AI supported, always compliant
With engamp® | intelligence, the engamp® platform integrates controlled, transparent, and fully traceable AI functions directly into your existing quality management processes. Users receive AI-powered assistance in understanding, searching, and evaluating quality-related content—without altering existing responsibilities, approval processes, or compliance structures.
- Human made decision
- Audit Trail
- Complete even without AI
AI in the engamp® | software suite
Artificial Intelligence (AI) as a component of the engamp® | platform
In regulated companies, quality-related information must be readily available, traceable, and accurate at all times. At the same time, the scope and complexity of SOPs, work instructions, test procedures, manufacturing documents, and other quality management documents are constantly increasing.
engamp® | intelligence makes this knowledge accessible directly within the engamp® | platform. AI helps users understand documents more quickly, find relevant information more effectively, and efficiently identify quality-related connections.
Unlike standalone AI solutions, engamp® | intelligence is fully integrated into existing processes. Permissions, approval mechanisms, and audit trail functions are retained, ensuring that AI support can be used in a controlled, transparent, and regulatory-compliant manner.
AI as a support, not a prerequisite
Every feature remains fully available even without AI
In a regulated environment, another question takes precedence over the question of what an AI function can do: What happens if it is not used or is not allowed to be used? No regulated process step in engamp® requires an AI function. AI makes tasks faster and easier to perform; it is never a mandatory part of a process step.
Your benefits with engamp® | intelligence
That's why regulated companies choose engamp® | intelligence
engamp® | intelligence integrates AI into documents in a controlled, transparent, and fully traceable manner
and into the processes of the engamp® suite.
01.
Capture information faster
Extensive quality management documents can be grasped more quickly using AI-generated summaries. Users get a concise, easy-to-understand overview of the content without having to manually browse entire documents.
02.
Accurate answers based on approved high-quality information
The built-in AI chat answers questions based on approved documents to which the respective user has access. Answers are tagged with source anchors, making them verifiable.
03.
Regulatory control throughout the AI process
AI-generated content is not automatically accepted or published. Every output remains subject to review and does not become effective until it has been released by a human in the loop.
04.
Full traceability
AI actions are documented in the audit trail. This ensures that interactions, releases, and decisions remain transparent and auditable.
05.
Seamless integration into existing processes
engamp® | intelligence complements the existing system landscape. Permissions, roles, document versions, and approval processes remain unchanged.
AI that complies with regulatory requirements
Core principles of engamp® | intelligence
Every planned AI feature is evaluated against these six principles before it is implemented.
Features of engamp® | intelligence
Features of engamp® | intelligence at a glance
Smart AI features help you find relevant information faster, understand content better, and streamline workflows.
Understand documents at the touch of a button
Automatically generated summaries help users grasp lengthy SOPs, work instructions, or process instructions more quickly.
Your advantages:
✔ Manual trigger for each document
✔ Summary in the language of the document
✔ Verification and release by authorised users
✔ Version-based storage for each document version
✔ Documentation in the audit trail
Transparent AI responses
The AI flags automatically generated content and distinguishes facts from interpretations.
Smart questionnaires
Smart questionnaires for AI-assisted creation of structured questionnaires
Automatic history of changes
Automatic history of changes for the AI-generated description of changes between document versions
Ask questions and get substantiated answers
The built-in AI chat allows users to ask questions in natural language about approved documents in the QM system. Users receive clear answers that are directly linked to the source.
Particularly relevant in a regulated environment:
✔ Natural-language chat
✔ Source anchors
✔ Document ID and version
✔ Access rights are considered
Full auditability
All AI interactions remain traceable and verifiable.
Smart version comparison
Smart version comparison for automatically identifying relevant document changes
Data processing in engamp® | intelligence
What content reaches the AI and what doesn't
In regulated companies, it’s not just what AI can do that matters, but what data it is even allowed to access.
Regulatory Requirements for AI in Quality Management
AI developed for regulated industries
The use of AI in quality management requires more than just technical capabilities. Control, transparency, data integrity, and regulatory traceability are crucial.
Product logic of engamp® | intelligence
Not a module, but an extension that applies to all modules
Unlike the other solutions in the engamp® | software suite, engamp® | intelligence is not a standalone functional area. If the add-on is purchased, it unlocks the AI features in all deployed solutions, from Document Control to Training Management to Supplier Qualification.
This add-on logic stems from the principle that no function requires AI. That is the only reason intelligence can be offered as an optional add-on at all. Customers without intelligence don't receive an incomplete product; rather, they forgo the benefits of acceleration.
Responsibility of engamp® | intelligence
What always compliant means—and what it doesn't
Compliance of the QMS is a design requirement for our product. Every AI feature in engamp® is designed to ensure that approvals, audit trails, and accountability remain intact. You remain responsible for ensuring the compliance of your processes. engamp® is designed so that it never gets in the way.
Background on engamp® | intelligence
Why we build AI this way
To learn about the principles behind the AI features in engamp®, how the regulatory framework surrounding Annex 22, the EU AI Act, and the ISPE GAMP® Guide is evolving, and where companies have already faltered in their use of AI, read the technical article “AI in the QMS”.
FAQ on engamp® | intelligence
Frequently Asked Questions (FAQs) about AI Support
This guide will help you learn more about our services and their features
Expand FAQs
engamp® | intelligence is an AI integration within the engamp® platform. It helps users compile quality management documents and retrieve quality-related information via an integrated AI chat.
No. AI serves solely as a support tool. Decisions, verifications, and releases remain the responsibility of the designated individuals.
No. Each issue is verified and released by a designated person before it is used.
Yes. The AI chatbot references the document ID, version, and section.
No. Customer data is not used to train models; this commitment is contractually guaranteed. Only content that the user consciously selects is provided to the AI. Background data from the system is not included in the transmission.
Yes. No regulated process step in engamp® requires an AI function; the full range of features remains available without engamp® | intelligence. Companies whose internal policies currently restrict the use of AI can implement the expansion at a later date.
AI-driven actions are documented in the audit trail. Responses in the AI chat include source anchors with the document ID, version, and section.
By default, only released documents that the respective user has permission to access are included.
Companies use the existing role and authorization concept to define which user groups are granted access.
Yes. All interactions are recorded in the audit trail.
Annex 22, “Artificial Intelligence,” describes for the first time how AI models must be validated, monitored, documented, and managed on a risk-based basis when they affect product quality, patient safety, or data integrity. The draft was released for public comment in July 2025; the final version is expected by the end of 2026.
You remain responsible for ensuring that your processes comply with regulations. The QMS's compliance status is a design requirement for engamp®, not a guarantee to the customer. The software is designed so that it does not interfere with your compliance and so that AI results never take effect without being reviewed.
Contact engamp® | intelligence
AI for Quality Management—Without Compromising Compliance and Traceability
Learn how engamp® | intelligence can help make your quality management processes more efficient, easier to understand, and more compliant with regulations.
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