EMLIFE operates in a nutraceutical manufacturing environment where production, laboratory testing, and quality assurance rely on a combination of documented procedures, manual records, and tacit knowledge accumulated through experience. While some processes are supported by Standard Operating Procedures (SOPs) and digital tools, a significant part of daily operations still depends on individual expertise, informal guidance, and fragmented information sources. This creates variability in execution and makes it difficult to ensure consistent knowledge transfer across teams.

One of the main challenges is related to onboarding and workforce development. Training new employees requires intensive supervision by experienced staff, and the quality of onboarding may vary depending on who delivers it. As a result, the learning curve is long, productivity is reduced during training periods, and the risk of procedural errors is higher. In parallel, internal mobility between packaging, production, and laboratory roles is limited due to the complexity of processes and the absence of structured, guided learning pathways.

Quality assurance and traceability represent another critical challenge. The production of live probiotic formulations requires strict compliance with Good Manufacturing Practice (GMP) standards and Hazard Analysis and Critical Control Points (HACCP) food safety systems, as well as accurate documentation of microbiological and physicochemical tests. In practice, quality-related information is distributed across different systems, paper records, and personal knowledge, which increases the effort required to retrieve, validate, and reconcile data. This can affect audit readiness, traceability, and overall operational efficiency.

From a technical and data perspective, EMLIFE faces difficulties in consolidating heterogeneous information sources into a unified and reusable framework. Process parameters, scientific references, quality records, and inventory data are not fully integrated, limiting their use for real-time decision support. This fragmentation reduces the potential value of existing data and prevents systematic learning from past production batches.

These challenges directly affect competitiveness, scalability, and operational resilience. As the company grows, dependence on key individuals, manual processes, and fragmented knowledge increases business risk and limits the ability to adapt quickly to market and production demands. Addressing these issues through a structured, human-centric Digital Intelligent Assistant (DIA) is therefore essential to improve reliability, workforce sustainability, and long-term industrial performance.

Objective 1:

To build a structured and validated digital knowledge base that consolidates EMLIFE’s laboratory and production procedures, scientific references, and quality requirements into a single cognitive digital twin, making critical operational knowledge accessible, traceable, and reusable across teams.

Objective 2:

To develop and deploy a Digital Intelligent Assistant that provides real-time, context-aware guidance to operators during quality assurance, onboarding, and daily production activities, while preserving human responsibility and ensuring compliance with regulatory and safety standards.

Objective 3:

To validate the assistant in real production conditions and demonstrate its impact on workforce development, process reliability, and internal mobility, including the facilitation of cross-role transitions from packaging to production roles without disrupting plant operations.

The PROBIO-AI experiment is carried out in the nutraceutical biotechnology sector, specifically in the manufacturing of liquid probiotic formulations based on live microbial cultures. The experiment takes place at EMLIFE’s production and laboratory facilities in Spain, within a real operational environment that includes fermentation processes, microbiological and physicochemical testing, bottling, and quality assurance activities. The project is implemented directly in day-to-day operations rather than in a simulated or isolated pilot setting, ensuring that results reflect practical industrial conditions.

The operational environment combines laboratory and production workflows, where strict coordination is required between testing activities, process monitoring, and quality validation. The assistant is deployed to support operators during routine and non-routine tasks, including quality checks, onboarding procedures, and cross-role training. Validation activities are conducted using real equipment, real production batches, and existing operational systems, allowing the experiment to assess usability and reliability under normal workload and time constraints.

The primary target users are laboratory technicians, production operators, and newly onboarded employees involved in fermentation, testing, and quality control. Secondary users include production supervisors and quality managers responsible for process validation and compliance. Relevant stakeholders also include technology providers, the Digital Innovation Hub, regulatory bodies, and professional partners who rely on EMLIFE’s compliance with quality and safety standards.

The experiment operates under established regulatory and operational constraints, including compliance with Good Manufacturing Practice (GMP) standards and Hazard Analysis and Critical Control Points (HACCP) food safety systems. Access to operational and quality data is governed by internal policies and data protection regulations, including pseudonymisation and controlled access rights. Integration with existing documentation systems, quality records, and inventory tools is required to ensure continuity of operations and avoid disruption of certified processes. These constraints shape the technical design of the assistant and ensure that innovation is compatible with certified industrial environments.