Automation Services

Basic and Detail Automation Engineering

  • basic automation engineering, user requirement specifications, functional specifications
  • hardware and software design specification, description of technological run-off control
  • electrical and pneumatic engineering, layout and evaluation of field instrumentation, measurement and control equipment
  • selection of process control systems, PLC, SCADA, visualization systems, layout and specification of interfaces (third party systems)
  • layout of recipe handling, report management and remote access

Configuration and Programming

  • programming and configuration of technological sequences
  • design of visualizations including human machine interfaces are designed according to FDA guidelines and international standards
  • parameterization of measurement and control devices
  • set-up of operating systems (virtualized or non-virtualized )
  • custom specific extensions of existing automation systems, coverage of interfaces to systems not delivered by ISE
  • documented design methodologies are conceived according to the life cycle model
  • batch control according to ISA-S88.0 (physical or procedural model), DIN EN61512-1, Namur NE33

Installation and Start-Up

  • purchase and delivery of process control systems, electrical and pneumatic installations, field instruments  
  • field instrumentation, hardware and software line tests (end to end)
  • functional tests of hardware and software
  • factory acceptance tests have been carried out on various projects
  • setup of aumotation networks - centralized PCS/SCADA systems - decentralized PCS/SCADA systems - virtualized PCS/SCADA systems

Validation

  • compliance with FDA "21 CFR Part 11" regulation, according to GaMP 4.0 & GaMP 5.0, ISPE Records and Data Integrity Guide
  • extensive experience in the preparation of risk analysis and traceability matrix related to automation systems 
  • we optimize the validation of our systems by following the GaMP 4.0 & GaMP 5.0 guidelines. Our systems can be validated easily since we guarantee documented quality throughout the whole life cycle of our products.
  • GMP compliant by using a proven structure for specifications and documentation of hardware, software, measurement and control equipment which are all incorporated in our projects and quality plans.
  • this includes the execution of test regimes for our products, IQ/OQ protocols and reports, execution of IQ and OQ activities for automation systems
  • support with the preparation of automation SOPs
  • advice with the installation of computerized system validation concepts (prospective and retrospective)

Maintenance and Support

  • 24 h customer support for hardware and software, world-wide maintenance contracts
  • software service on site or teleservice via modem/ VPN/ remote administration software
  • guaranteed response times, conservation of the validated system status by means of a GaMP compliant on going life cycle
  • preparation of maintenance plans and operating manuals
  • software updates