AKTS Microsystems supports industrial companies, laboratories, public authorities, operators of critical infrastructure and food manufacturers in the technical implementation of traceable, documentation-ready and long-term maintainable systems. Services range from customer-specific software and regulation-oriented IT infrastructures to sensor hardware and monitoring solutions for temperature, relative humidity, light, pressure and other technical parameters in climate, storage, production and laboratory rooms. Requirements for data integrity, audit trails, user and permission concepts, alarming, backup, recovery and long-term data retention are specified on a project- and risk-based basis. Binding compliance assessment, process approval and validation responsibility remain with the respective operator and are clearly delineated within the project.
Systems are not described generically as compliant or validated. Applicable requirements, system boundaries, responsibilities, evidence and acceptance criteria are defined on a customer-, process- and risk-based basis. This keeps technical commitments robust and traceable for operators, quality assurance and auditors.
Architecture, configuration, data flows, interfaces, user roles, tests, releases and changes can be structured and documented to support qualification, validation, acceptance and audit activities. Documentation is aligned with the actual system lifecycle and operating model.
Audit trails, role and permission concepts, timestamps, alarming, change tracking, and backup and restore evidence can be considered in software, infrastructure and monitoring systems. This also applies to long-term measurement series from climate and storage rooms, for example temperature and humidity monitoring in food, pharmaceutical and laboratory environments.
The technical depth is determined by criticality, data types, user groups, system boundaries, outage impact and regulatory context. For public authorities, critical infrastructure and regulated operations, security, availability, recovery and documentation requirements are integrated into the architecture and operating model at an early stage.
Depending on the process, risk analysis, data criticality and operator requirements, the following areas can be included in software, sensor, monitoring or infrastructure projects.
A robust implementation begins with clear system boundaries, data classification, role models, audit-trail requirements, measurement and alarm requirements, retention periods, backup objectives and documented acceptance criteria.
