The module includes functionalities that use Artificial Intelligence (AI) to support users in executing defined business processes by generating proposals, extracting information, or assisting with data interpretation and preparation. These AI-supported capabilities are intended to improve efficiency, consistency, and usability, but they do not replace the need for qualified user oversight, procedural control, or business validation.
All AI-generated outputs must be reviewed, assessed, and approved by authorized users before they are accepted, imported, used operationally, or relied upon for GMP-relevant or business-critical decisions. The user remains responsible for verifying the completeness, correctness, and appropriateness of the proposed results in accordance with applicable procedures, internal controls, and regulatory requirements.
The Document Intelligence – Test group functionality can be used to support importing test group documents in the system, with AI assistance.