AIS Automations- und Informationssysteme AG | Engineering, Software & Validation

// 01 / ENGINEERING

Engineering with mathematical precision.

CAx

CAx Software Development

Development of highly specialised, mathematical software solutions with seamless integration for CAD/CAM/CAE systems for computer-aided component design and the digitalisation of your manufacturing processes.

Below are three automation examples we have implemented:

RoBi, the pipe-bending system, fully automatically generates CAD-based drawings of pipes and complex hoses from specifications, for example from a measuring machine. Without the system, a CAD user needs an average of about 3 hours for such a drawing; with RoBi, this task is completed in 15 minutes at most.
Planschi, the floating stability program, can analyse any volume model with regard to its floating position and stability. Among other things, the calculation results include the submerged volume as a CAD model and stability diagrams with spatially assigned righting moments.
ToMaS, the tool management system, selects NC tools optimised for the machining case specified by the user. Already in the second year of use, tool costs amounting to three times the project volume were saved.

ENG

Engineering Services & Component Development

Project-based design and development support across the entire component lifecycle – from the initial concept through detailed design to a manufacturing-ready outcome.

Whether reinforcing your design team on an ongoing project or delivering a standalone development service – we bring proven engineering expertise, independent of the CAD system in use, and support components and assemblies reliably through to series production. Structured configuration management ensures traceable revision states, clear versioning and consistent bills of materials throughout – especially where many variants arise in prototyping.

// 02 / SOFTWARE

Software for regulated industries.

CODE

Integrated Software Development

System components in highly regulated industries demand uncompromising quality-assurance processes. We apply formal methods throughout the entire design and implementation phase.

This is complemented by comprehensive testing and integration measures, including formal methods such as model checking, the representation of system models in process algebras (e.g. CSP), and the systematic derivation of test cases from system models and source code.

IAC

Secure IT Infrastructures by IaC

For us, security in distributed infrastructures means consistently protecting interfaces and the information exchanged between them – through formal methods in design and implementation as well as comprehensive testing and integration measures.

We integrate and harden open-source components such as Kubernetes, Docker, as well as APIs (JSON, REST, OAuth) – with a focus on reliable, reproducible deployment in virtual environments, for example with Ansible, Packer and Proxmox.

// 03 / VALIDATION

Computer system validation and equipment qualification.

Qualification

Increasing automation is merging computer system validation with classic equipment qualification. Our expertise brings IT and process engineering together, applying agile IT validation methods to qualification projects to deliver a time and cost advantage for you.

Good Manufacturing Practice (GMP) stands for consistent quality and process standards in pharmaceutical manufacturing. This includes supporting our clients in creating GxP-compliant user requirements as well as qualification and validation plans, including risk analyses. We also support the planning and execution of the DQ, IQ, OQ and PQ phases, as well as risk-based qualification of change-control-relevant equipment or component changes and cleanroom facilities. Finally, we summarise and evaluate the qualification results in a clear and comprehensible way, with particular focus on the traceability of test results.

CSV

Computer System Validation

Legally compliant qualification and validation of computer-based systems in accordance with legal and regulatory requirements in the healthcare sector and the pharmaceutical industry.

We implement all standards and guidelines required in the GxP-regulated environment (e.g. GAMP5, 21 CFR Part 11) based on the classic V-model or agile variants – including data integrity in line with ALCOA+ and a risk-based approach that scales from a simple laboratory device to complex systems for clinical trials. As a competent partner, we offer GxP-compliant validation management, including the planning, organisation and execution of all validation activities. We relieve your specialist departments while ensuring compliance with regulatory requirements.

// CONTACT / LOCATIONS

Ready to start a project together?

Get in touch directly with one of our local teams.

Kassel

Harleshäuser Str. 92
34128 Kassel
Germany

+49 331 2012684

+49 331 2014794

info@ais-ag.de

Potsdam

Behlertstraße 21
14469 Potsdam
Germany

+49 331 2012684

+49 331 2014794

info@ais-ag.de