HEITEC AG

Digital engineering, automation and qualification/validation for the industry

HEITEC stands for future-proof automation solutions in the pharmaceutical and packaging industries. Our focus: digital transformation, GMP-compliant systems, and intelligent robotics solutions for cleanrooms and production environments.
We provide comprehensive support to our customers—from concept development and URS creation through engineering and integration to qualification, validation, and operation.

Key areas of focus include:

• Mobile Cleanroom Robotics (H.U.G.S.)
• Contactless Authentication (Nymi®)
• MES/SCADA Integration
• GMP Compliance (Annex 1, Annex 11, GAMP 5)

As a systems integrator, we connect OT and IT to create a seamless, resilient, and validated process landscape.

Consulting & Design

• GMP Strategy (Annex 1 / 11 / 22)
• URS & Requirements Specifications
• Digitalization Roadmaps
• Process Analysis & Use Cases

Implementation & Integration

• SCADA / MES / HMI
• Robotics & Automation
• Connectivity (OPC UA, APIs)
• Data Integration & IIoT

Qualification & Validation

• GAMP 5-based Validation
• IQ / OQ / PQ
• Audit Trails & Data Integrity
• Documentation Packages

Operation & Services

• Lifecycle Management
• Remote Service & Support
• Cybersecurity (IEC 62443)
• Retrofit, Software Maintenance & Updates

Highlights

H.U.G.S. – Cleanroom Robotics

Mobile robotics solution for cleanrooms designed to perform environmental monitoring, material handling, and automated processes. Reduces human intervention and increases process reliability.

Contactless Authentication (Nymi®)

Secure, contactless authentication for GMP environments—ideal for MES, LIMS, and machine operation in cleanrooms.

Digital Batch & Data Integration

Integration of production, quality, and process data for complete transparency and auditability.

from left to right: H.U.G.S. – Cleanroom Robotics, Contactless Authentication (Nymi®), Digital Batch & Data Integration

Specifics

1. End-to-End System Integrator (OT + IT + GMP)
2. Validation- and audit-ready solutions
3. Innovations such as cleanroom robotics and contactless authentication solutions
4. Long-term partnerships and lifecycle support